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Takahashi K, Nosaka T, Murata Y, Sugata R, Akazawa Y, Tanaka T, Naito T, Matsuda H, Ohani M, Suto H, Nakamoto Y. Influence of antiplatelet drugs on gastric ulcer healing after endoscopic submucosal dissection in patients with early gastric cancer. DEN OPEN 2025; 5:e70070. [PMID: 39935747 PMCID: PMC11811763 DOI: 10.1002/deo2.70070] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 10/23/2024] [Revised: 01/16/2025] [Accepted: 01/20/2025] [Indexed: 02/13/2025]
Abstract
Objectives The causes of drug-induced gastroduodenal injuries primarily include antithrombotic drugs, including low-dose aspirin, non-steroidal anti-inflammatory drugs, and corticosteroids. These drugs are suspected to affect gastric ulcer healing after endoscopic submucosal dissection (ESD). This study aimed to investigate the effects of these drugs on post-ESD ulcer healing. Methods This study included 170 lesions (149 patients) who had undergone ESD for early gastric cancer. Post-ESD ulcers were endoscopically measured on the 1st, 28th, and 56th days after ESD and were analyzed to identify potential risk factors for delayed ulcer healing among patients taking antiplatelet drugs, anticoagulant drugs, non-steroidal anti-inflammatory drugs, corticosteroids, and no drugs. Results Multivariate analysis for the frequency of scarring on the 56th day after ESD showed that antiplatelet drugs (odds ratio [OR], 3.905; p = 0.017), ulcer size of ≥40 mm on the first day (OR, 4.903; p = 0.006), hemoglobin A1c ≥6.5% (OR 7.659, p = 0.012), and age of ≥75 (OR, 5.227; p = 0.007) were independent risk factors of delayed ulcer healing. Anticoagulant drugs, non-steroidal anti-inflammatory drugs, and corticosteroids were not significant factors. Among antiplatelet drugs, the ulcer reduction ratio for clopidogrel on the 28th day after ESD was 84.8%, which was significantly lower than the ulcer reduction ratio of 92.8% for no drug (p < 0.05). Conclusions As antiplatelet drugs, particularly clopidogrel, may delay gastric ulcer healing after ESD, careful endoscopic follow-up and drug therapy are suggested for patients taking these drugs.
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Affiliation(s)
- Kazuto Takahashi
- Second Department of Internal Medicine, Faculty of Medical SciencesUniversity of FukuiFukuiJapan
| | - Takuto Nosaka
- Second Department of Internal Medicine, Faculty of Medical SciencesUniversity of FukuiFukuiJapan
| | - Yosuke Murata
- Second Department of Internal Medicine, Faculty of Medical SciencesUniversity of FukuiFukuiJapan
| | - Ryotaro Sugata
- Second Department of Internal Medicine, Faculty of Medical SciencesUniversity of FukuiFukuiJapan
| | - Yu Akazawa
- Second Department of Internal Medicine, Faculty of Medical SciencesUniversity of FukuiFukuiJapan
| | - Tomoko Tanaka
- Second Department of Internal Medicine, Faculty of Medical SciencesUniversity of FukuiFukuiJapan
| | - Tatsushi Naito
- Second Department of Internal Medicine, Faculty of Medical SciencesUniversity of FukuiFukuiJapan
| | | | - Masahiro Ohani
- Second Department of Internal Medicine, Faculty of Medical SciencesUniversity of FukuiFukuiJapan
| | - Hiroyuki Suto
- Department of GastroenterologyFukui Katsuyama General HospitalFukuiJapan
| | - Yasunari Nakamoto
- Second Department of Internal Medicine, Faculty of Medical SciencesUniversity of FukuiFukuiJapan
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Zhu B, Chen L, Tao X, Zheng H, Li X, Wu Q, Long E, Lin H. Current research status and trends of potassium-competitive acid blockers in the treatment of acid-related diseases: a bibliometric analysis. Front Pharmacol 2025; 15:1477633. [PMID: 39840081 PMCID: PMC11747516 DOI: 10.3389/fphar.2024.1477633] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/08/2024] [Accepted: 12/16/2024] [Indexed: 01/23/2025] Open
Abstract
Objective To explore the current research status and trends of potassium-competitive acid blockers (P-CABs) in the treatment of acid related diseases (ARDs) using bibliometric analysis. Materials and methods We collected publications related to P-CAB in the treatment of acid-related diseases in the Web of Science (WOS) Core Collection from the establishment of the database to 30 June 2024. We evaluated the publication volume and citation status over the years using the WOS platform, and visualized the authors, countries, institutions, keywords, and citations of the publications using CiteSpace and VOSviewer. Results This study included a total of 455 articles. The number of publications and citations related to research has been increasing year by year. The results show that the scholars with the highest number of publications mainly come from South Korea and Japan. Scholars such as Geun Seog Song, Bongtae Kim, and Nobuhiro Inatomi produced many works in related fields. The most popular drug in this field was vonoprazan, and research on this drug mainly focused on the effectiveness and safety evaluation of ARDs such as Helicobacter pylori infection, gastroesophageal reflux disease, peptic ulcers, etc. Researchers were concerned about the evaluation of treatment regimens and efficacy comparison between P-CABs and traditional proton pump inhibitors (PPIs) in the treatment of ARDs. At the same time, researchers are also closely monitoring the potential adverse reactions and long-term adverse outcomes of clinical application of P-CABs for ARDs. Conclusion The clinical application of P-CABs, represented by vonoprazan, in ARDs is receiving widespread attention from researchers. The exploration of the application of this type of drug in ARDs is constantly expanding, and it is a research field with great clinical value and research potential.
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Affiliation(s)
- Baoqiang Zhu
- Department of Pharmacy, The First People’s Hospital of Shuangliu District, West China (Airport) Hospital of Sichuan University, Chengdu, China
| | - Long Chen
- Department of Pharmacy, The First People’s Hospital of Shuangliu District, West China (Airport) Hospital of Sichuan University, Chengdu, China
| | - Xue Tao
- Department of Pharmacy, Personalized Drug Therapy Key Laboratory of Sichuan Province, Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
| | - Hong Zheng
- Department of Pharmacy, The First People’s Hospital of Shuangliu District, West China (Airport) Hospital of Sichuan University, Chengdu, China
| | - Xia Li
- Department of Pharmacy, The First People’s Hospital of Shuangliu District, West China (Airport) Hospital of Sichuan University, Chengdu, China
| | - Qingfang Wu
- Department of Pharmacy, The First People’s Hospital of Shuangliu District, West China (Airport) Hospital of Sichuan University, Chengdu, China
| | - Enwu Long
- Department of Pharmacy, Personalized Drug Therapy Key Laboratory of Sichuan Province, Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
| | - Haixia Lin
- Department of Pharmacy, The First People’s Hospital of Shuangliu District, West China (Airport) Hospital of Sichuan University, Chengdu, China
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Kim BW, Park JJ, Moon HS, Lee WS, Shim KN, Baik GH, Lim YJ, Lee HL, Youn YH, Park JC, Sung IK, Chung H, Moon JS, Kim GH, Hong SJ, Choi HS. The Effect of Tegoprazan on the Treatment of Endoscopic Resection-Induced Artificial Ulcers: A Multicenter, Randomized, Active-Controlled Study. Gut Liver 2024; 18:257-264. [PMID: 38384180 PMCID: PMC10938149 DOI: 10.5009/gnl230242] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/25/2023] [Revised: 08/18/2023] [Accepted: 08/22/2023] [Indexed: 02/23/2024] Open
Abstract
BACKGROUND/AIMS : Tegoprazan is a novel potassium-competitive acid blocker that has beneficial effects on acid-related disorders such as gastroesophageal reflux and peptic ulcer diseases. This study aimed to validate the effect of tegoprazan on endoscopic submucosal dissection (ESD)-induced artificial ulcers. METHODS : Patients from 16 centers in Korea who underwent ESD for gastric neoplasia were enrolled. After ESD, pantoprazole was administered intravenously for 48 hours. The patients were randomly allocated to either the tegoprazan or esomeprazole group. Tegoprazan 50 mg or esomeprazole 40 mg were administered for 4 weeks, after which gastroscopic evaluation was performed. If the artificial ulcer had not healed, the same dose of tegoprazan or esomeprazole was administered for an additional 4 weeks, and a gastroscopic evaluation was performed. RESULTS : One hundred sixty patients were enrolled in this study. The healing rates of artificial ulcers at 4 weeks were 30.3% (23/76) and 22.1% (15/68) in the tegoprazan and esomeprazole groups, respectively (p=0.006). At 8 weeks after ESD, the cumulative ulcer healing rates were 73.7% (56/76) and 77.9% (53/68) in the tegoprazan and esomeprazole groups, respectively (p=0.210). Delayed bleeding occurred in two patients in the tegoprazan group (2.6%) and in one patient in the esomeprazole group (1.5%). Other adverse events were negligible in both groups. CONCLUSIONS : Tegoprazan showed similar effects on post-ESD artificial ulcer healing in comparison with esomeprazole.
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Affiliation(s)
- Byung-Wook Kim
- Department of Internal Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Jong Jae Park
- Division of Gastroenterology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea
| | - Hee Seok Moon
- Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Korea
| | - Wan Sik Lee
- Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun, Korea
| | - Ki-Nam Shim
- Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea
| | - Gwang Ho Baik
- Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea
| | - Yun Jeong Lim
- Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, Korea
| | - Hang Lak Lee
- Department of Internal Medicine, Hanyang University Medical Center, Seoul, Korea
| | - Young Hoon Youn
- Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Jun Chul Park
- Department of Gastroenterology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - In-Kyung Sung
- Department of Internal Medicine, Konkuk University Medical Center, Konkuk University College of Medicine, Seoul, Korea
| | - Hyunsoo Chung
- Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
| | - Jeong Seop Moon
- Department of Internal Medicine, Inje University Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Gwang Ha Kim
- Department of Internal Medicine, Pusan National University College of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea
| | - Su Jin Hong
- Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea
| | - Hyuk Soon Choi
- Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea
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Chen L, Jiang D, Hu D, Cui X. Comparison of vonoprazan and proton pump inhibitors for the treatment of gastric endoscopic submucosal dissection-induced ulcer: an updated systematic review and meta-analysis. BMC Gastroenterol 2024; 24:110. [PMID: 38491413 PMCID: PMC10943859 DOI: 10.1186/s12876-024-03198-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/10/2023] [Accepted: 03/08/2024] [Indexed: 03/18/2024] Open
Abstract
BACKGROUND Both vonoprazan and proton pump inhibitors (PPIs) are currently used to treat artificial ulcers after gastric endoscopic submucosal dissection. However, evidence-based medicine proving the efficacy of vonoprazan is still lacking. Therefore, this meta-analysis aimed to compare the efficacy of vonoprazan and PPIs for the treatment of artificial ulcers after gastric endoscopic submucosal dissection. METHODS The PubMed, EMBASE and Cochrane Library databases were searched up to September 2023 for related randomized controlled trials (RCTs). RCTs that compared the efficacy of vonoprazan and PPIs in treating artificial gastric ulcers after gastric endoscopic submucosal dissection were included. Two independent reviewers screened the included studies, extracted the data and assessed the risk of bias. The following outcomes were extracted for comparison: ulcer healing rate, ulcer shrinkage rate, delayed postoperative bleeding rate, and ulcer perforation rate. RESULTS Nine randomized controlled trials involving 926 patients were included. The pooled results showed that vonoprazan had a significantly lower rate of delayed postoperative bleeding than did PPIs (RR = 0.46; 95% CI = 0.23-0.91; P = 0.03). No significant differences were found in terms of ulcer healing, shrinkage rates, or ulcer perforation rates between vonoprazan and PPIs. CONCLUSIONS Compared with PPIs, vonoprazan is superior at reducing delayed postoperative bleeding after endoscopic submucosal dissection. However, further studies are needed to prove the efficacy of vonoprazan. SYSTEMATIC REVIEW REGISTRATION Identifier CRD42024509227.
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Affiliation(s)
- Lizhen Chen
- Department of Infectious Disease, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao, Shandong, China
| | - Dalei Jiang
- Department of Gastroenterology, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao, Shandong, China
| | - Doudou Hu
- Department of Gastroenterology, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao, Shandong, China
| | - Xianghua Cui
- Department of Gastroenterology, Qingdao Hospital, University of Health and Rehabilitation Sciences (Qingdao Municipal Hospital), Qingdao, Shandong, China.
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The importance of pH adjustment for preventing fibrin glue dissolution in the stomach: an in vitro study. Sci Rep 2022; 12:6986. [PMID: 35484272 PMCID: PMC9050883 DOI: 10.1038/s41598-022-10968-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/06/2021] [Accepted: 03/29/2022] [Indexed: 12/31/2022] Open
Abstract
Combined use of fibrin glue and polyglycolic acid (PGA) sheets has attracted attention as a preventive measure for complications associated with endoscopic submucosal dissection. However, fibrin glue is a protein that may be dissolved by gastric acid. We evaluated the effect of artificial gastric acid on fibrin clot. The dissolution time of three layers of fibrin glue with PGA sheets was measured in five groups (pH 1.2, 2.0, 4.0, 5.5, and 6.0 with pepsin). Measurements of three samples per group were made. The mean number of the remaining layers at each measurement point was observed for 168 h. The time to complete dissolution of the three layers of fibrin gel in the three samples was 2.5 h at pH 1.2, 5 h at pH 2.0, 24 h at pH 4.0, and 48 h and 6 h at pH 5.5. In order to maintain fibrin glue in the stomach for a long period, there was a need to avoid pepsin activation secondary to acidification of gastric juice. The use of strong antacids is recommended.
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Shiratori Y, Niikura R, Ishii N, Ikeya T, Honda T, Hasatani K, Yoshida N, Nishida T, Sumiyoshi T, Kiyotoki S, Arai M, Kawai T, Fukuda K. Vonoprazan versus proton pump inhibitors for postendoscopic submucosal dissection bleeding in the stomach: a multicenter population-based comparative study. Gastrointest Endosc 2022; 95:72-79.e3. [PMID: 34237329 DOI: 10.1016/j.gie.2021.06.032] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/23/2021] [Accepted: 06/30/2021] [Indexed: 12/11/2022]
Abstract
BACKGROUND AND AIMS The effectiveness of vonoprazan relative to that of proton pump inhibitors (PPIs) after gastric endoscopic submucosal dissection (ESD) is unclear. Although previous studies used post-ESD ulcer healing as the outcome measure, post-ESD bleeding rate is the most objective and appropriate outcome measure because it has less ascertainment bias. We aimed to compare the post-ESD bleeding rates between vonoprazan and PPIs. METHODS This nationwide population-based retrospective cohort study was conducted between 2014 and 2018 and involved 9 hospitals. After 2 days of intravenous PPI administration, either vonoprazan or PPI was administrated from postoperative day 2 to 30. RESULTS Overall, data of 1715 patients (627 patient pairs) were analyzed through propensity score matching. The vonoprazan group had significantly lower post-ESD bleeding rates than the PPI group (overall, 11.9% vs 17.2%, P = .008; bleeding between days 2 and 30, 7.8% vs 11.8%, P = .015). The readmission rate because of post-ESD bleeding was lower in the vonoprazan group (2.4% vs 4.1%, P = .081). Blood transfusion (2.1% vs 3.0%, P = .15) and additional surgery because of delayed perforation (.5% vs 1.0%, P = .32) were not significantly different between the 2 groups. No deaths within 30 days occurred in both groups. On Cox regression analysis, vonoprazan use, lesion location (antrum), aspirin use, direct oral anticoagulant use, and Charlson Comorbidity Index (≥2) were associated with an increased risk of post-ESD bleeding within 30 days. CONCLUSIONS Vonoprazan has a lower post-ESD bleeding rate than PPIs. Further prospective studies are required to confirm these results.
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Affiliation(s)
- Yasutoshi Shiratori
- Department of Gastroenterology, St Luke's International Hospital, Tokyo, Japan
| | - Ryota Niikura
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Gastroenterological Endoscopy, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan
| | - Naoki Ishii
- Department of Gastroenterology, Tokyo Shinagawa Hospital, Tokyo, Japan
| | - Takashi Ikeya
- Department of Gastroenterology, St Luke's International Hospital, Tokyo, Japan
| | - Tetsuro Honda
- Department of Gastroenterology, Nagasaki Harbor Medical Center, Nagasaki-shi, Nagasaki, Japan
| | - Kenkei Hasatani
- Department of Gastroenterology, Fukui Prefectural Hospital, Fukui-shi, Fukui, Japan
| | - Naohiro Yoshida
- Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa-shi, Ishikawa, Japan
| | - Tsutomu Nishida
- Department of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka-shi, Osaka, Japan
| | - Tetsuya Sumiyoshi
- Department of Gastroenterology, Tonan Hospital, Sapporo-shi, Hokkaido, Japan
| | - Shu Kiyotoki
- Department of Gastroenterology, Shuto General Hospital, Yanai-shi, Yamaguchi, Japan
| | - Masahiro Arai
- Department of Gastroenterology, Nerima Hikarigaoka Hospital, Nerima-ku, Tokyo, Japan
| | - Takashi Kawai
- Gastroenterological Endoscopy, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan
| | - Katsuyuki Fukuda
- Department of Gastroenterology, St Luke's International Hospital, Tokyo, Japan
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Li M, Jin H, Shi C, Lyu B, Ying X, Shi Y. A Novel Self-Assembled Gel for Gastric Endoscopic Submucosal Dissection-Induced Ulcer: A Preclinical Study in a Porcine Model. Front Pharmacol 2021; 12:700387. [PMID: 34658850 PMCID: PMC8517079 DOI: 10.3389/fphar.2021.700387] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/28/2021] [Accepted: 09/20/2021] [Indexed: 01/15/2023] Open
Abstract
Endoscopic submucosal dissection (ESD) is a routine procedure for the management of early gastrointestinal neoplasia, but it results in large ulcers. This study aims to examine the feasibility and effectiveness of a newly developed self-assembled gel on the ulcer healing process after ESD. Sixteen 2.0-cm (diameter) gastric ulcers were created by ESD in five pigs. All ulcers were randomized: control group (n = 7, routine ulcer management) and gel-treated group (n = 9). The gel was applied to cover the whole ulcer bed through the endoscope immediately after ESD. The feasibility of this endoscopic treatment modality was macroscopically accessed by endoscopy. The effectiveness was evaluated based on the ulcer area and histology changes at 14 days after ESD. The gel-treated group showed higher healing activity compared with the control ulcers on day 14 after ESD. The percentage of healing was higher for the gel-treated ulcers than in control ones (96.2 ± 2.2% vs. 91.9 ± 4.5%, p = 0.035). The extent of the new epithelium covering the ulcer was greater in the gel group than in controls. One delayed overt bleeding occurred in the control group (14.3%). This novel gel might promote the speed of ulcer healing after ESD, leading to higher epithelium formation.
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Affiliation(s)
| | | | | | - Bin Lyu
- Department of Gastroenterology, First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China
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Ishida T, Dohi O, Yamada S, Yasuda T, Yamada N, Tomie A, Tsuji T, Horii Y, Majima A, Horie R, Fukui A, Zen K, Tomatsuri N, Yagi N, Naito Y, Itoh Y. Clinical Outcomes of Vonoprazan-Treated Patients after Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Multicenter Observation Study. Digestion 2021; 102:386-396. [PMID: 32585678 DOI: 10.1159/000507807] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/13/2020] [Accepted: 04/09/2020] [Indexed: 02/04/2023]
Abstract
BACKGROUND Vonoprazan (VPZ) has the potential to prevent delayed bleeding and promote ulcer healing after endoscopic submucosal dissection (ESD) similar to proton pump inhibitors (PPIs). OBJECTIVE We aimed to evaluate the outcomes of VPZ-treated patients after ESD and compared the efficacy and feasibility in preventing a delayed bleeding and in healing an artificial ulcer after ESD between the VPZ and PPI therapies. METHODS This was a prospective, observation study in 11 Japanese medical institutions. We enrolled and evaluated 223 patients who underwent gastric ESD followed by VPZ treatment (VPZ group). We selected 385 patients who underwent gastric ESD followed by PPI treatment as historical controls (PPI group) to compare the outcomes between the VPZ and PPI groups using a propensity score matching analysis. RESULTS Among the 223 patients treated with VPZ, 173 were men and 50 were women with a median age of 72 years and with a median tumor size of 12.0 mm. Rates of en bloc resection and complete resection were 99.1 and 94.2%, respectively. Lymphovascular invasion was found in 6 (6.3%) cases. Intraoperative perforation and delayed bleeding occurred in 3 (1.3%) and 10 patients (4.5%), respectively. Scarring of artificial post-ESD ulcer was found in 153 patients (68.6%) at 6 weeks after ESD. The 205 pairs of propensity score-matched patients were comparable between the VPZ and PPI groups. The rate of delayed bleeding in the VPZ and PPI groups was 3.9 and 4.4%, respectively (difference, 0.5 percentage points; 95% confidence interval, -3.7 to 2.8%; non-inferiority, p = 0.01). Therefore, VPZ therapy demonstrated non-inferiority against PPI therapy in reducing the rate of delayed bleeding. The scar-stage ulcer at 6 weeks in the VPZ group and 8 weeks in the PPI group was 68.3 and 74.6%, respectively (p = 0.19). CONCLUSIONS VPZ therapy showed an efficacy and feasibility in preventing a delayed bleeding after ESD similar to the PPI therapy. VPZ for 6 weeks and PPI for 8 weeks were similarly effective for an artificial ulcer healing after ESD.
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Affiliation(s)
- Tsugitaka Ishida
- Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
| | - Osamu Dohi
- Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan,
| | - Shinya Yamada
- Department of Gastroenterology and Hepatology, Japanese Red Cross Society Kyoto Daiichi Hospital, Kyoto, Japan
| | - Takeshi Yasuda
- Department of Gastroenterology, Asahi University Hospital, Gifu, Japan
| | - Nobuhisa Yamada
- Department of Gastroenterology, Matsushita Memorial Hospital, Osaka, Japan
| | - Akira Tomie
- Department of Gastroenterology, Kyoto Yamashiro General Medical Center, Kyoto, Japan.,Department of Gastroenterology, Saiseikai Kyoto Hospital, Kyoto, Japan
| | - Toshifumi Tsuji
- Department of Gastroenterology, Fukuchiyama City Hospital, Kyoto, Japan
| | - Yusuke Horii
- Department of Gastroenterology, Maizuru Medical Center, Kyoto, Japan.,Department of Gastroenterology, Medical Corporation Keishinkai, Kyoto Kidugawa Hospital, Kyoto, Japan
| | - Atsushi Majima
- Department of Gastroenterology and Hepatology, Omihachiman Community Medical Center, Shiga, Japan
| | - Ryusuke Horie
- Department of Gastroenterology, JCHO Kyoto Kuramaguchi Medical Center, Kyoto, Japan
| | - Akifumi Fukui
- Department of Gastroenterology, North Medical Center Kyoto Prefectural University of Medicine, Kyoto, Japan
| | - Keika Zen
- Department of Gastroenterology, Otsu City Hospital, Shiga, Japan
| | - Naoya Tomatsuri
- Department of Gastroenterology and Hepatology, Japanese Red Cross Society Kyoto Daiichi Hospital, Kyoto, Japan
| | - Nobuaki Yagi
- Department of Gastroenterology, Asahi University Hospital, Gifu, Japan
| | - Yuji Naito
- Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
| | - Yoshito Itoh
- Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
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9
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Kawai D, Takenaka R, Ishiguro M, Okanoue S, Gotoda T, Kono Y, Takemoto K, Tsugeno H, Fujiki S. Vonoprazan versus lansoprazole in the treatment of artificial gastric ulcers after endoscopic submucossal dissection: a randomized, open-label trial. BMC Gastroenterol 2021; 21:236. [PMID: 34022796 PMCID: PMC8141195 DOI: 10.1186/s12876-021-01822-5] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/01/2020] [Accepted: 05/19/2021] [Indexed: 12/15/2022] Open
Abstract
Background Vonoprazan is more potent and longer acting than traditional proton pump inhibitor. Although vonoprazan is expected to be superior to proton pump inhibitor, its efficacy in the treatment of gastric ulcers following endoscopic submucosal dissection (ESD) is not fully understood. The aim of this study was to evaluate the effectiveness of vonoprazan in artificial ulcer healing following ESD. Methods Patients with gastric tumors were randomly assigned to the vonoprazan group (group V) or lansoprazole group (group L) after ESD. Patients received intravenous lansoprazole (30 mg) twice on the day of ESD. Thereafter, patients were treated with vonoprazan (20 mg/day) in group V or lansoprazole (30 mg/day) in group L. Esophagogastroduodenoscopy was performed 4 and 8 weeks after the ESD. Results A total of 168 patients were analyzed. The 4-week healing rate for artificial ulcer was not significantly higher in group V versus group L (17/85, 20.0% vs. 14/83, 16.9%, respectively). In addition, there were no significant differences between the 4-week shrinkage rates between the two groups. Postoperative bleeding occurred in none of the patients in group V and three in group L. One patient in group V presented delayed perforation 2 days after ESD. Conclusions Vonoprazan might not be superior to lansoprazole in the healing of artificial gastric ulcer after ESD. Trial registration: University hospital Medical Information Network (registration number: UMIN000016642), Registered 27 February 2015, https://www.umin.ac.jp/ctr/index-j.htm.
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Affiliation(s)
- Daisuke Kawai
- Department of Gastroenterology, Tsuyama Chuo Hospital, 1756, Kawasaki, Tsuyama, Okayama, 708-0841, Japan
| | - Ryuta Takenaka
- Department of Gastroenterology, Tsuyama Chuo Hospital, 1756, Kawasaki, Tsuyama, Okayama, 708-0841, Japan.
| | - Mikako Ishiguro
- Department of Gastroenterology, Tsuyama Chuo Hospital, 1756, Kawasaki, Tsuyama, Okayama, 708-0841, Japan
| | - Shotaro Okanoue
- Department of Gastroenterology, Tsuyama Chuo Hospital, 1756, Kawasaki, Tsuyama, Okayama, 708-0841, Japan
| | - Tatsuhiro Gotoda
- Department of Gastroenterology, Tsuyama Chuo Hospital, 1756, Kawasaki, Tsuyama, Okayama, 708-0841, Japan
| | - Yoshiyasu Kono
- Department of Gastroenterology, Tsuyama Chuo Hospital, 1756, Kawasaki, Tsuyama, Okayama, 708-0841, Japan
| | - Koji Takemoto
- Department of Gastroenterology, Tsuyama Chuo Hospital, 1756, Kawasaki, Tsuyama, Okayama, 708-0841, Japan
| | - Hirofumi Tsugeno
- Department of Gastroenterology, Tsuyama Chuo Hospital, 1756, Kawasaki, Tsuyama, Okayama, 708-0841, Japan
| | - Shigeatsu Fujiki
- Department of Gastroenterology, Tsuyama Chuo Hospital, 1756, Kawasaki, Tsuyama, Okayama, 708-0841, Japan
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10
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Ban H, Inatomi O, Murata M, Otsuka T, Oi M, Matsumoto H, Bamba S, Andoh A. Vonoprazan vs lansoprazole for the treatment of artificial gastric ulcer after endoscopic submucosal dissection: a prospective randomized comparative study. J Clin Biochem Nutr 2021; 68:259-263. [PMID: 34025030 PMCID: PMC8129974 DOI: 10.3164/jcbn.20-143] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/26/2020] [Accepted: 09/17/2020] [Indexed: 12/14/2022] Open
Abstract
Vonoprazan is a potent inhibitor of gastric acid secretion and may have better response than proton pump inhibitors (PPIs) in the treatment of endoscopic submucosal dissection induced artificial ulcers. However, reported outcomes remain controversial. In this study, we conducted a prospective, randomized comparative trial to evaluate healing effects of vonoprazan and lansoprazole on endoscopic submucosal dissection (ESD)-induced ulcers. We enrolled 216 patients who underwent endoscopic submucosal dissection for early gastric neoplasms. They were randomly divided into vonoprazan (20 mg/day) and lansoprazole (30 mg/day) groups. The primary endpoint was the reduction rate of ulcer and complete healing (scar) ratio of ESD-induced ulcers at 4 and 8 weeks. Finally, 101 patients of the vonoprazan group and 95 patients of the lansoprazole group were included in the analysis. There were no significant differences in the reduction rate between the vonoprazan and lansoprazole groups at either timepoint (4 weeks, 94.0 vs 93.4%; 8 weeks, 99.8 vs 99.9%, respectively). The complete healing ratio at 4 and 8 weeks did not differ significantly between the vonoprazan and lansoprazole groups (4 weeks, 11.9 vs 12.6%; 8 weeks, 87.1 vs 86.3%, respectively). In the anti-H. pylori-antibody negative or positive patients, there were no significant differences in the reduction rate and complete healing ratio between the vonoprazan and lansoprazole groups. Regardless of treatment choice, the overall complete healing ratio at 8 weeks was significantly higher in the anti-H. pylori-antibody negative patients than the positive patients (p = 0.006). The healing effects of vonoprazan on ESD-induced ulcers were comparative to those of lansoprazole.
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Affiliation(s)
- Hiromitsu Ban
- Department of Medicine, Shiga University of Medical Science, Seta Tsukinowa, Otsu 520-2192, Japan
- Department of Gastroenterology, Kusatsu General Hospital, Yabase-cho 1660, Kusatsu, Shiga 525-8585, Japan
| | - Osamu Inatomi
- Department of Medicine, Shiga University of Medical Science, Seta Tsukinowa, Otsu 520-2192, Japan
| | - Masaki Murata
- Department of Medicine, Shiga University of Medical Science, Seta Tsukinowa, Otsu 520-2192, Japan
| | - Taketo Otsuka
- Department of Medicine, Shiga University of Medical Science, Seta Tsukinowa, Otsu 520-2192, Japan
| | - Masayuki Oi
- Department of Medicine, Shiga University of Medical Science, Seta Tsukinowa, Otsu 520-2192, Japan
| | - Hiroshi Matsumoto
- Department of Medicine, Shiga University of Medical Science, Seta Tsukinowa, Otsu 520-2192, Japan
| | - Shigeki Bamba
- Department of Medicine, Shiga University of Medical Science, Seta Tsukinowa, Otsu 520-2192, Japan
| | - Akira Andoh
- Department of Medicine, Shiga University of Medical Science, Seta Tsukinowa, Otsu 520-2192, Japan
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11
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Toya Y, Endo M, Sugai K, Yamada S, Oizumi T, Morishita T, Akasaka R, Yanai S, Nakamura S, Eizuka M, Uesugi N, Sugai T, Matsumoto T. Protective effect of proton pump inhibitors and potassium competitive acid blockers against post-gastric endoscopic submucosal dissection bleeding: a single-center, propensity score-matched analysis. Scand J Gastroenterol 2021; 56:199-204. [PMID: 33332216 DOI: 10.1080/00365521.2020.1862906] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
OBJECTIVES Both potassium-competitive acid blockers (P-CABs) and proton pump inhibitors (PPIs) are known to be protective against bleeding after gastric endoscopic dissection (ESD) for early gastric cancers. The aim was to compare the effect of PPI and P-CAB treatment against bleeding after gastric ESD. MATERIALS AND METHODS This was a single-center, retrospective analysis. Among 541 patients who underwent gastric ESD during the period from 2014 to 2019, we recruited subjects who were treated with PPIs (intravenous lansoprazole followed by oral esomeprazole) or a P-CAB before and after ESD. The incidence of post-ESD bleeding was compared between treatment groups. The risks associated with post-ESD bleeding were examined by univariate and multivariate analyses after propensity score-matching. RESULTS The overall incidence of post-ESD bleeding was not significantly different between patients treated with PPIs (n = 362) and those treated with a P-CAB (n = 156) (3.0% vs 2.6%, respectively; p = .77). Even after propensity score matching (n = 153 in each group), the incidence was not significantly different between groups (2.6% vs 2.6%, respectively; p = 1.00). A multivariate analysis revealed that antithrombotic therapy (OR 4.85, 95% CI 1.14-20.57) was an independent factor associated with post-ESD bleeding. CONCLUSIONS The incidence of post gastric ESD bleeding is not different between patients treated with PPI and patients treated with P-CAB. Antithrombotic therapy is an independent risk factor associated with post-ESD bleeding.
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Affiliation(s)
- Yosuke Toya
- Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Yahaba, Japan
| | - Masaki Endo
- Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Yahaba, Japan.,Kaiunbashi Endoscopy Clinic, Morioka, Japan
| | - Kyohei Sugai
- Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Yahaba, Japan
| | - Shun Yamada
- Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Yahaba, Japan
| | - Tomofumi Oizumi
- Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Yahaba, Japan
| | - Toshifumi Morishita
- Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Yahaba, Japan
| | - Risaburo Akasaka
- Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Yahaba, Japan
| | - Shunichi Yanai
- Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Yahaba, Japan
| | - Shotaro Nakamura
- Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Yahaba, Japan
| | - Makoto Eizuka
- Division of Molecular Diagnostic Pathology, Department of Pathology, School of Medicine, Iwate Medical University, Yahaba, Japan
| | - Noriyuki Uesugi
- Division of Molecular Diagnostic Pathology, Department of Pathology, School of Medicine, Iwate Medical University, Yahaba, Japan
| | - Tamotsu Sugai
- Division of Molecular Diagnostic Pathology, Department of Pathology, School of Medicine, Iwate Medical University, Yahaba, Japan
| | - Takayuki Matsumoto
- Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Yahaba, Japan
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12
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Chen X, Xu MT, Wen JB. Meta-analysis of vonoprazan and proton pump inhibitors in preventing delayed bleeding and facilitating ulcer healing after gastric endoscopic submucosal dissection. Shijie Huaren Xiaohua Zazhi 2020; 28:1249-1260. [DOI: 10.11569/wcjd.v28.i24.1249] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Vonoprazan (VPZ) is a novel potassium-competitive acid blocker that has been widely used in Japan for Helicobacter pylori eradication and for treatment of gastroeasophageal reflux disease and peptic ulcer. Compared with proton pump inhibitors (PPIs), VPZ can inhibit acid secretion more stably and effectively. Based on the results of previous studies, we speculated that compared with PPIs, VPZ is more effective in preventing delayed bleeding and facilitating ulcer healing after gastric endoscopic submucosal dissection (ESD).
AIM To compare the efficacy of VPZ and PPIs in preventing delayed bleeding and facilitating ulcer healing after gastric ESD.
METHODS We collected randomized controlled trials (RCTs) or cohort studies on the effectiveness of VPZ and PPIs in ESD-induced ulcer and delayed bleeding from electronic datasets including PubMed, EMBASE, Cochrane Library, Google Scholar, CNKI database, Wanfang database, and VIP database. The Cochrane Risk of Bias Tool and Newcastle Ottawa Quality Assessment Scale were applied to evaluate the quality of the articles included. Meta-analysis was performed using software Revman 5.2. Publication bias was assessed and Begg's graphs were drawn using Stata 14.0. Trim and fill analysis was performed when the publication bias was significant.
RESULTS Nineteen studies were included in this Meta-analysis. The overall risk ratio (RR) of VPZ relative to PPIs for delayed bleeding was 0. 86 (P = 0. 38; 95%CI: 0.61-1.21). The RR in the subgroup of antithrombotic patientes was 1.35 (P = 0.54; 95%CI: 0.52-3.48), while the RR in the subgroup of non-antithrombotic patients was 0.68 (P = 0.12; 95%CI: 0.41-1.10). The RR of VPZ relative to PPIs was 1.37 (P = 0.02; 95%CI: 1.06-1.77) at 4 wk and 1.02 (P = 0.60; 95%CI: 0.95-1.09) at 8 wk. After excluding three studies with combination treatment, the RRs for delayed bleeding, ulcer healing at 4 wk, and ulcer healing at 8 wk were 0.90 (P = 0.56), 1.34 (P = 0.04), and 1. 02 (P = 0.60), respectively.
CONCLUSION During the first 4 wk after gastric ESD, VPZ promotes ulcer healing faster than PPIs. At the end of the 8th weeks after ESD, there is no significant difference between VPZ and PPIs for ulcer healing. In the postoperative population with or without using antithrombotic drugs, compared with PPIs, VPZ does not exhibit any superiority in preventing delayed bleeding.
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Affiliation(s)
- Xuan Chen
- Department of Gastroenterology, Pingxiang Hospital, Affiliated Hospital of Southern Medical University, Pingxiang 337000, Jiangxi Province, China
| | - Meng-Ting Xu
- Department of Gastroenterology, Pingxiang Hospital, Affiliated Hospital of Southern Medical University, Pingxiang 337000, Jiangxi Province, China
| | - Jian-Bo Wen
- Department of Gastroenterology, Pingxiang Hospital, Affiliated Hospital of Southern Medical University, Pingxiang 337000, Jiangxi Province, China
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13
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Suto D, Yoshida M, Otake T, Ichiishi E, Sato K, Murata K, Ebinuma H, Odaira H, Suzuki Y, Kohgo Y. Effects of vonoprazan on gastric PH and clinical course after gastric ESD: A retrospective and prospective study. Ann Med Surg (Lond) 2020; 60:27-30. [PMID: 33101669 PMCID: PMC7578543 DOI: 10.1016/j.amsu.2020.10.002] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2020] [Revised: 09/25/2020] [Accepted: 10/05/2020] [Indexed: 12/13/2022] Open
Abstract
Background Vonoprazan has been more widely used for artificial ulcers after endoscopic submucosal dissection (ESD) for early gastric cancer; however, no reports have examined intragastric pH during ESD. The present study aimed to measure gastric pH at the time of ESD and the clinical course afterwards for patients treated with vonoprazan the night before undergoing ESD. Materials and methods We examined medication status regarding gastric acid secretion and antithrombotic drugs, post-ESD bleeding as a perioperative complication, and the timing of upper gastrointestinal endoscopy after ESD and ulcer healing in 156 patients who underwent gastric ESD at our hospital from January 2014 to December 2019. The gastric pH was measured at the time of ESD after administration of 20 mg vonoprazan on the night before gastric ESD. Results There were 14 cases of post-ESD bleeding in patients treated with proton-pump inhibitors (PPIs), including oozing during second-look endoscopy compared to only 1 case of bleeding with vonoprazan administration (p < 0.05). Vonoprazan was also associated with better post-ESD ulcer healing than PPIs. Gastric pH during ESD after vonoprazan administration on the night before gastric ESD was ≥6.96 in all 11 patients. Conclusion Post-ESD bleeding was reduced, and ulcer healing was improved in patients treated with vonoprazan the night before their procedure. Our results suggest high gastric pH during ESD due to vonoprazan administration may be beneficial for hemostasis and ulcer healing following ESD.
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Affiliation(s)
- Daisuke Suto
- Department of Gastroenterology, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi, 329-2763, Japan
- Corresponding author.
| | - Masashi Yoshida
- Department of Surgery, International University of Health and Welfare Hospital, 537-3, Iguchi, Nasushiobara, Tochigi, 329-2763, Japan
| | - Takaaki Otake
- Department of Gastroenterology, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi, 329-2763, Japan
| | - Eiichiro Ichiishi
- Department of Gastroenterology, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi, 329-2763, Japan
| | - Kiichi Sato
- Department of Gastroenterology, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi, 329-2763, Japan
| | - Kazumoto Murata
- Department of Gastroenterology, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi, 329-2763, Japan
| | - Hirotoshi Ebinuma
- Department of Gastroenterology and Hepatology, International University of Health and Welfare, Narita Hospital, 852, Hatagata, Narita, Chiba, 286-8520, Japan
| | - Hironori Odaira
- Department of Surgery, International University of Health and Welfare Hospital, 537-3, Iguchi, Nasushiobara, Tochigi, 329-2763, Japan
| | - Yutaka Suzuki
- Department of Surgery, International University of Health and Welfare Hospital, 537-3, Iguchi, Nasushiobara, Tochigi, 329-2763, Japan
| | - Yutaka Kohgo
- Department of Gastroenterology, International University of Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara, Tochigi, 329-2763, Japan
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14
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Li DF, Xiong F, Xu ZL, Zhang DG, Yao J, Wang LS. Polyglycolic acid sheets decrease post-endoscopic submucosal dissection bleeding in early gastric cancer: A systematic review and meta-analysis. J Dig Dis 2020; 21:437-444. [PMID: 32573104 DOI: 10.1111/1751-2980.12908] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/12/2019] [Revised: 05/07/2020] [Accepted: 05/17/2020] [Indexed: 12/11/2022]
Abstract
OBJECTIVE Endoscopic submucosal dissection (ESD) is the standard treatment for early gastric cancer (EGC). However, post-ESD bleeding remains a serious issue, particularly in patients treated with an antithrombotic agent or those have had a large mucosal resection (≥4 cm). Whether covering the ulcer bed induced by ESD with polyglycolic acid (PGA) sheets can prevent post-ESD bleeding remains to be questioned. Therefore, we performed a systematic review and meta-analysis to evaluate the effectiveness of PGA sheets on preventing post-ESD bleeding in patients with early gastric cancer (EGC) at a high risk of post-ESD bleeding. METHODS PubMed, Cochrane Library and EMBASE databases were searched for studies on the effect of PGA sheets shielding on inpatients with EGC and at a high risk of bleeding using post-ESD bleeding rate as the primary outcome. RESULTS Among the four included studies (212 lesions in the PGA sheet group and 208 in the control group), post-ESD bleeding rate was significantly lower in the PGA sheet group than in the control group (4.9% vs 13.7%, risk ratio [RR] 0.33, 95% confidence interval [CI] 0.18-0.72, P = 0.004). A subgroup analysis showed that the application of PGA sheets effectively reduced the post-ESD bleeding rate in patients receiving antithrombotic agents (5.5% vs 15.2%; RR 0.37, 95% CI 0.17-0.79, P = 0.01). Although the application of PGA sheets tended to decrease the post-ESD bleeding rate in patients who had undergone large mucosal resections, the difference was not significant (4.5% vs 9.6%; RR 0.52, 95% CI 0.15-1.78, P = 0.29). CONCLUSIONS PGA sheets can effectively prevent post-ESD bleeding in patients receiving antithrombotic agents. Further studies are needed to confirm whether PGA sheets can decrease post-ESD bleeding in patients underwent large mucosal resection.
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Affiliation(s)
- De Feng Li
- Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong Province, China
| | - Feng Xiong
- Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong Province, China
| | - Zheng Lei Xu
- Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong Province, China
| | - Ding Guo Zhang
- Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong Province, China
| | - Jun Yao
- Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong Province, China
| | - Li Sheng Wang
- Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology), Shenzhen, Guangdong Province, China
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15
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Fushimi S, Horikawa Y, Mizutamari H, Mimori N, Kato Y, Sato S. Feasibility of gastric endoscopic submucosal dissection without using proton pump inhibitor injection: a propensity score analysis. J Rural Med 2020; 15:85-91. [PMID: 32704333 PMCID: PMC7369407 DOI: 10.2185/jrm.2019-021] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/23/2019] [Accepted: 02/20/2020] [Indexed: 11/27/2022] Open
Abstract
Purpose: Endoscopic submucosal dissection is a promising method for the resection of superficial gastric neoplasms. To date, several institutions have used proton pump inhibitor injections over the perioperative period. However, there is very little evidence regarding their efficacy. To overcome this limitation, we compared procedural outcomes and the prevention of adverse events of proton pump inhibitor injection with an orally administered active potassium-competitive acid blocker alone. Participants and Methods: We enrolled a total of 150 patients treated for superficial gastric neoplasms at a single institution between April 2015 and December 2018. Patients treated for 2 days with proton pump inhibitor injections following 12 days of oral potassium-competitive acid blocker (proton pump inhibitor group=80) were compared with patients treated for 14 days orally with potassium-competitive acid blocker alone (potassium-competitive acid blocker group=70) using propensity score analysis. We evaluated intragastric pH levels prior to endoscopic submucosal dissection, frequency of intraoperative major bleeding, procedure time, en bloc resection rate, curability, ulcer reduction rate 14 days after endoscopic submucosal dissection, and adverse events (including perforation and postoperative bleeding). Results: Propensity score analysis yielded 43 matched pairs. The comparison demonstrated similar values for the outcomes. For all cases, we observed intragastric pH levels >6.4 prior to endoscopic submucosal dissection. Postoperative bleeding rates were 2.3% (1/43) in the proton pump inhibitor group and 0.0% (0/43) in the potassium-competitive acid blocker group (P=0.315). Conclusions: Oral potassium-competitive acid blocker alone was as effective as proton pump inhibitor injection, with a low incidence of adverse events. Based on these results, proton pump inhibitor injection might be omitted during gastric endoscopic submucosal dissection.
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Affiliation(s)
- Saki Fushimi
- Department of Gastroenterology, Hiraka General Hospital, Japan
| | - Yohei Horikawa
- Department of Gastroenterology, Hiraka General Hospital, Japan
| | | | - Nobuya Mimori
- Department of Gastroenterology, Hiraka General Hospital, Japan
| | - Yuhei Kato
- Department of Gastroenterology, Hiraka General Hospital, Japan
| | - Sayaka Sato
- Department of Gastroenterology, Hiraka General Hospital, Japan
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16
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Yoshii S, Yamada T, Yamaguchi S, Hayashi Y, Nakahara M, Shibukawa N, Yamamoto M, Ishihara R, Kinoshita K, Egawa S, Tsujii Y, Iijima H, Takehara T. Efficacy of vonoprazan for the prevention of bleeding after gastric endoscopic submucosal dissection with continuous use of antiplatelet agents. Endosc Int Open 2020; 8:E481-E487. [PMID: 32258369 PMCID: PMC7089797 DOI: 10.1055/a-1067-4380] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/19/2019] [Accepted: 10/15/2019] [Indexed: 12/15/2022] Open
Abstract
Background Post-procedural bleeding, after gastric endoscopic submucosal dissection (ESD) for high risk thromboembolic cases that require continuous antiplatelet therapy, is challenging. Its incidence rate is > 20 % among those using conventional antacids. We evaluated the efficacy of perioperative management with vonoprazan to prevent post-ESD bleeding. Materials and methods This was a multicenter prospective interventional trial conducted at 10 Japanese referral centers. Patients who regularly used antiplatelet agents (aspirin or thienopyridine derivatives, etc.) and who required continuous antithrombotic medication due to high thromboembolic risk were enrolled. They underwent gastric ESD with continuous aspirin therapy. Oral administration of vonoprazan (20 mg daily) was started from the day of ESD and continued for 28 days. The primary end point was the incidence of post-ESD bleeding. The sample size was 50 patients, and vonoprazan was considered to be effective when the upper threshold of the 95 % confidence interval (CI) for post-ESD bleeding did not exceed 20 %. Results Although 50 patients were enrolled, one patient withdrew consent. Therefore, 49 patients were included in the analysis. One patient who used aspirin and clopidogrel experienced bleeding 11 days after ESD. The overall post-ESD bleeding rate was 2.0 % (1/49; 95 %CI 0.4-10.7 %). Thromboembolic events were not observed. One case of ESD-associated adverse events (perforation) and one case of drug-associated adverse events (drug eruption, possibly due to vonoprazan) were observed. Conclusions Vonoprazan may be efficacious for preventing post-ESD bleeding in patients using continuous antiplatelet therapy, warranting further comparative study to definitively test the effectiveness of the drug.
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Affiliation(s)
- Shunsuke Yoshii
- Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
| | - Takuya Yamada
- Department of Gastroenterology, Osaka Rosai Hospital, Osaka, Japan,Department of Gastroenterology, National Hospital Organization Osaka National Hospital, Osaka, Japan
| | | | - Yoshito Hayashi
- Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
| | - Masanori Nakahara
- Department of Gastroenterology, Ikeda Municipal Hospital, Osaka, Japan
| | | | - Masashi Yamamoto
- Department of Gastroenterology, Toyonaka Municipal Hospital, Osaka, Japan
| | - Ryu Ishihara
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan
| | - Kazuo Kinoshita
- Department of Gastroenterology, Otemae Hospital, Osaka, Japan
| | - Satoshi Egawa
- Department of Gastroenterology, Osaka Police Hospital, Osaka, Japan
| | - Yoshiki Tsujii
- Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
| | - Hideki Iijima
- Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan
| | - Tetsuo Takehara
- Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan,Corresponding author Tetsuo Takehara, MD PhD Department of Gastroenterology and HepatologyOsaka University Graduate School of Medicine2-2YamadaokaSuitaOsakaJapan+81-6-68793629
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17
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Martin, Zhou Y, Meng CX, Takagi T, Tian YS. Vonoprazan vs proton pump inhibitors in treating post-endoscopic submucosal dissection ulcers and preventing bleeding: A meta-analysis of randomized controlled trials and observational studies. Medicine (Baltimore) 2020; 99:e19357. [PMID: 32118778 PMCID: PMC7478518 DOI: 10.1097/md.0000000000019357] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/02/2019] [Revised: 12/17/2019] [Accepted: 01/29/2020] [Indexed: 12/11/2022] Open
Abstract
BACKGROUND Vonoprazan is a potassium-competitive acid blocker (P-CAB) that is frequently used in Japan for Helicobacter pylori (H. pylori) eradication, treatment of gastroesophageal reflux disease, and treatment of post endoscopic submucosal dissection (ESD) complications. We sought to determine if vonoprazan was superior to proton pump inhibitors (PPIs) for treating ESD-induced ulcers (as assessed by ulcer healing and shrinkage ratios) and preventing delayed bleeding over various treatment durations (2, 4, and 8 weeks). METHODS We collected randomized controlled trials (RCTs) and observational studies that discussed the effectiveness of vonoprazan and PPIs on ESD-induced ulcers and bleeding from PubMed, Cochrane Library, ClinicalTrials.gov, and Google Scholar. Studies were selected according to pre-established eligibility criteria and data were extracted separately by 2 researchers with double-check. We used the Cochrane risk of bias tool to assess RCTs and the Newcastle-Ottawa Quality Assessment Scale to assess observational studies. Meta-analyses, based on the random-effects model, were conducted to compare differences in ulcer shrinkage ratios (%) and odds ratios (ORs) for ulcer healing and delayed bleeding. Publication bias was evaluated using funnel plots and Egger regression test. Heterogeneity was assessed using I statistics. A sensitivity analysis was conducted to check the robustness of results. The evidential quality of the findings was assessed using the GRADE profiler. RESULTS Thirteen studies were included in this meta-analysis. The OR effect sizes of vonoprazan relative to PPIs for ulcer healing were 1.33 (P = .13) with a 95% CI (0.33-3.21) at 4 weeks and 1.48 (P = .09) with a 95% CI (0.81-5.20) at 8 weeks. The overall effect size for the shrinkage ratio was 12.24% (P = .16) with a 95% CI (-4.96-29.44) at 2 weeks. The effect size of its subgroup of H. pylori-positive patients was 19.51% (P < .001) with a 95% CI (11.91-27.12). The overall OR for the occurrence of delayed bleeding was 0.66 (P = .26) with a 95% CI (0.32-1.35). After excluding combination drug studies, the overall ORs between vonoprazan and PPIs on ulcer healing and delayed bleeding were 1.44 and 0.76, respectively. CONCLUSION During the first 2 weeks of treatment, vonoprazan was more effective than PPIs for treating H. pylori-positive patients with ESD-induced gastric ulcers.
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18
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Kikuchi D, Iizuka T, Makino S, Hayasaka J, Odagiri H, Ochiai Y, Suzuki Y, Nomura K, Ohkura Y, Okamoto Y, Tanaka M, Matsui A, Mitani T, Hoteya S. Utility of autologous fibrin glue and polyglycolic acid sheet for preventing delayed bleeding associated with antithrombotic therapy after gastric ESD. Endosc Int Open 2019; 7:E1542-E1548. [PMID: 31723577 PMCID: PMC6847688 DOI: 10.1055/a-1007-1694] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/01/2019] [Accepted: 08/23/2019] [Indexed: 02/08/2023] Open
Abstract
Background and study aims Delayed bleeding is one of the most serious adverse events of gastric endoscopic submucosal dissection (ESD), especially in patients taking antithrombotic therapy. This study aimed to evaluate the utility and safety of a shielding method with autologous fibrin glue and polyglycolic acid (PGA) sheets for patients undergoing gastric ESD who are receiving antithrombotic therapy. Patients and methods One hundred twenty-three patients who were treated with gastric ESD while receiving antithrombotic therapy between December 2014 and September 2017 were enrolled in this study. Patients who received the shielding method were classified into the shielding group. Others were classified into the conventional group. Various clinico-pathological factors were retrospectively compared between the two groups. Results The shielding group consisted of 38 patients, and the conventional group consisted of the remaining 85 patients. In the shielding group, the rate of continuation of antithrombotic therapy was significantly higher (68.4 % vs 41.2 %). Incidence of delayed bleeding was lower in the shielding group (2.6 %, 1/38) than in the conventional group (14.1 %, 12/85). In the propensity score-adjusted logistic regression analysis, the delayed bleeding rate in the shielding group tended to be lower than in the conventional group ( P = 0.070). Allogeneic transfusion was performed in eight patients (8/85, 9.4 %) in the conventional group and none in the shielding group ( P = 0.047). No adverse event associated with endoscopic shielding were observed in the shielding group. Conclusions This study suggests that a shielding method with autologous fibrin glue and PGA sheet effectively prevents delayed bleeding after gastric ESD in patients receiving antithrombotic therapy.
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Affiliation(s)
- Daisuke Kikuchi
- Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan,Corresponding author Daisuke Kikuchi, MD, PhD 2-2-2 Toranomon Minato-kuTokyoJapan+81-3-3582-7068
| | - Toshiro Iizuka
- Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan
| | - Shigeyoshi Makino
- Department of Transfusion medicine, Toranomon Hospital, Tokyo, Japan
| | | | - Hiroyuki Odagiri
- Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan
| | - Yorinari Ochiai
- Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan
| | - Yugo Suzuki
- Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan
| | - Kosuke Nomura
- Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan
| | - Yu Ohkura
- Department of Surgery, Toranomon Hospital, Tokyo, Japan
| | - Yosuke Okamoto
- Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan
| | - Masami Tanaka
- Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan
| | - Akira Matsui
- Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan
| | - Toshifumi Mitani
- Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan
| | - Shu Hoteya
- Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan
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Liu C, Feng BC, Zhang Y, Li LX, Zuo XL, Li YQ. The efficacy of vonoprazan for management of post-endoscopic submucosal dissection ulcers compared with proton pump inhibitors: A meta-analysis. J Dig Dis 2019; 20:503-511. [PMID: 31414725 DOI: 10.1111/1751-2980.12813] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/10/2019] [Revised: 08/02/2019] [Accepted: 08/09/2019] [Indexed: 12/24/2022]
Abstract
OBJECTIVE Artificial ulcers after endoscopic submucosal dissection (ESD) are usually treated by proton pump inhibitors (PPIs) in clinical setting. Vonoprazan, a newly developed potassium-competitive acid blocker, has recently been used to treat post-ESD ulcers. We aimed to evaluate the efficacy and safety of vonoprazan on the healing of post-ESD artificial ulcers compared with those of proton pump inhibitors (PPIs) using a meta-analysis. METHODS EMBASE, MEDLINE, Scopus and Cochrane Library databases were searched for all studies comparing the efficacy and safety of vonoprazan with those of PPIs in the treatment of post-ESD ulcers. RESULTS Fourteen articles with 1328 patients were included in this meta-analysis. When comparing ulcer shrinkage rate, vonoprazan showed a better efficacy than PPIs (mean difference 0.56, 95% confidence interval [CI] 0.18-0.93). Vonoprazan also led to a higher scar formation rate (odds ratio [OR] 1.58, 95% CI 1.00-2.47) and showed a potential superiority on reducing the risk of post-ESD bleeding compared with PPIs, with a pooled OR of 0.69, although there was no statistically significant difference. CONCLUSIONS Compared with PPIs, vonoprazan showed a better efficacy in ulcer shrinkage rate and achieved more complete healing in the treatment of post-ESD ulcers. Vonoprazan did not induce any incremental risk of post-ESD bleeding as well. It may be an appropriate choice in the management of artificial ulcers after ESD.
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Affiliation(s)
- Chao Liu
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
| | - Bing Cheng Feng
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
| | - Yan Zhang
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
| | - Li Xiang Li
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
| | - Xiu Li Zuo
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
| | - Yan Qing Li
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
- Laboratory of Translational Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong Province, China
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Effectiveness of fibrin sealant as hemostatic technique in accelerating ESD-induced ulcer healing: a retrospective study. Surg Endosc 2019; 34:1191-1199. [PMID: 31236721 DOI: 10.1007/s00464-019-06872-1] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/10/2018] [Accepted: 05/20/2019] [Indexed: 02/07/2023]
Abstract
OBJECTIVES Healing of gastric endoscopic submucosal dissection (ESD)-induced ulcer is critical for patient recovery. During ESD treatment, submucosal incisions are made with an electrosurgical knife to accomplish en bloc resections of superficial lesions. Nevertheless, excess electrocoagulation may decrease the blood supply of ESD-induced ulcer and delay the ulcer healing. The aim of this retrospective study was to evaluate the effectiveness of conservative electrocoagulation followed by porcine fibrin sealant (FS) as a wound microvessels-protective hemostatic technique in promoting the healing of ESD-induced ulcer. METHODS A total of 332 patients with early gastric cancer (EGCs), or gastric precancerous lesion and gastric adenoma were retrospectively analyzed. Propensity score matching was used to compensate for the differences in age, gender, tumor location, resected specimen area, and pathology. One-month ulcer healing rates and delayed bleeding were compared between two matched groups (combined hemostats group and electrocautery group). RESULTS A total of 115 matched pairs were created after propensity score matching. There was no difference in tumor location, specimen surface area, tumor differentiation and invasion depth between groups. The completed healing rate 1 month after ESD was 44.3% in combined hemostats group and 30.4% in electrocautery group (P = 0.004). There was no difference in delayed massive bleeding rate between two groups (P = 0.300). In addition, based on the multivariate regression analysis for ulcer healing rate, the use of FS (OR, 0.348, 95% CI 0.196 - 0.617, P = 0.000) and larger specimen size (OR, 2.640, 95% CI 2.015-3.458, P = 0.000) were associated with nonhealing ulcer 1 month after ESD. CONCLUSION Applying conservative electrocoagulation followed by porcine FS as a wound microvessels-protective hemostatic technique can promote ESD-induced ulcer healing without increasing delayed bleeding.
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Kang H, Kim BJ, Choi G, Kim JG. Vonoprazan versus proton pump inhibitors for the management of gastric endoscopic submucosal dissection-induced artificial ulcer: A systematic review with meta-analysis. Medicine (Baltimore) 2019; 98:e15860. [PMID: 31192917 PMCID: PMC6587628 DOI: 10.1097/md.0000000000015860] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022] Open
Abstract
BACKGROUND Vonoprazan, a novel potassium-competitive acid blocking agent, has been used in the management of endoscopic submucosal dissection (ESD)-induced artificial ulcers. This study aimed to perform a systematic review and meta-analysis for the comparison of the effects of vonoprazan and proton pump inhibitors (PPIs) in treating ESD-induced artificial ulcers and preventing delayed bleeding in randomized controlled trial and cohort studies. METHODS We searched OVID-MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), Google Scholar, and clinical trial registries in April 2018 to identify all studies that assess and compare the effects of vonoprazan and PPI in treating ESD-induced artificial ulcers and preventing delayed bleeding. Primary outcome of ulcer healing rate and secondary outcomes of shrinkage rate, ulcer size, and delayed bleeding were studied. RESULTS A total of 1265 patients from 12 studies were included in the final analysis. Healing rate at 4 weeks post-ESD was significantly higher in the vonoprazan group than in the PPI group (relative ratio [RR] 1.20 [1.03-1.40]). However, healing rate at 8 weeks post-ESD was significantly higher in the PPI group than in the vonoprazan group (RR 0.68 [0.48-0.97]).There was no evidence of significant difference between groups in shrinkage rate at 4 weeks post-ESD, shrinkage rate at 8 weeks post-ESD, delayed bleeding, ulcer size at 0 weeks post-ESD, and ulcer size at 8 weeks post-ESD. CONCLUSIONS There was no substantial difference in ulcer healing and post-ESD bleeding between vonoprazan and PPIs. However, vonoprazan more rapidly and effectively treated artificial ulcers after ESD than did PPIs.
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Affiliation(s)
- Hyun Kang
- Department of Anesthesiology and Pain Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea
| | - Beom Jin Kim
- Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea
| | - Geunjoo Choi
- Department of Anesthesiology and Pain Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea
| | - Jae Gyu Kim
- Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea
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Ko J, Kim SJ, Kang DH, Choi CW, Kim HW, Park SB. Dose-related healing of artificial ulcers after endoscopic submucosal dissection using esomeprazole: A randomized controlled study. Medicine (Baltimore) 2019; 98:e15701. [PMID: 31096515 PMCID: PMC6531125 DOI: 10.1097/md.0000000000015701] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/11/2018] [Revised: 12/10/2018] [Accepted: 04/23/2019] [Indexed: 12/13/2022] Open
Abstract
BACKGROUND Endoscopic submucosal dissection (ESD) is a standard procedure for treating gastric neoplasms. However, ESD causes larger artificial ulcers other than mucosal resection methods. We conducted this prospective randomized controlled study to evaluate the effect of stronger acid suppression on ESD ulcers caused by doubling the proton pump inhibitor (PPI) dose and compare the effects of 20-mg (standard dose) and 40-mg (double dose) esomeprazole (EswonampTM, Daewon Pharmaceutical Co., Ltd., Seoul, Korea) on ulcer healing. METHODS One hundred ninety-seven patients who underwent gastric ESD from July 2017 to December 2017 at Pusan National University Yangsan Hospital were enrolled and randomly assigned to the standard or double-dose group. Change in ulcer size from the day of ESD to 4 weeks after ESD and the scar-change rate were compared between the groups. RESULTS There were no significant differences in ulcer contraction (84.5% in 20 mg group vs 86.3% in 40 mg group, P = .91) or scar-change rate (30.9% vs 30.6%, P > .99) between the groups. In a multivariate analysis, initial ulcer size [odds ratio (OR) 0.24; 95% confidence interval (CI) 0.11-0.50] and early gastric cancer (OR 0.22, 95% CI 0.08-0.58) were significantly associated with delayed ulcer healing. CONCLUSIONS Both 40 and 20-mg esomeprazole have similar effects on ESD-induced ulcer area reduction, suggesting that strong acid suppression does not necessarily result in rapid artificial ulcer healing. TRIAL REGISTRATION NUMBER RCT no.: KCT0002885.
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Komori H, Ueyama H, Nagahara A, Akazawa Y, Takeda T, Matsumoto K, Matsumoto K, Asaoka D, Hojo M, Yao T, Watanabe S. A prospective randomized trial of a potassium competitive acid blocker vs proton pump inhibitors on the effect of ulcer healing after endoscopic submucosal dissection of gastric neoplasia. J Int Med Res 2019; 47:1441-1452. [PMID: 30816056 PMCID: PMC6460617 DOI: 10.1177/0300060519828514] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/23/2022] Open
Abstract
Background/Aims Vonoprazan is a new a potassium-competitive acid blocker (P-CAB) that was recently developed in Japan. However, vonoprazan’s efficacy in healing gastric ulcers after endoscopic submucosal dissection (ESD) remains controversial. This study aimed to compare the efficacy of P-CABs and proton pump inhibitors (PPIs) in healing post-ESD ulcers. Materials and Methods This prospective randomized controlled trial (UMIN000017386) enrolled 40 patients with gastric neoplasia, who underwent ESD at our hospital from April 2015 to January 2016. Before ESD, patients were randomly divided into the following two groups: group V, vonoprazan 20 mg/day; or group R, rabeprazole 10 mg/day. Medications were taken 1 day before to 4 weeks after ESD. The ESD-induced artificial ulcer size was measured just after ESD and 4 weeks after ESD to calculate the reduction rate as follows: (ulcer area 4 weeks after ESD)/(ulcer area just after ESD) × 100. Results Eighteen patients in group V and 15 patients in group R were analyzed. The mean reduction rate was significantly different in groups V and R (93.3% vs 96.6%, respectively). Post-ESD bleeding was observed in two patients in group R and drug-induced hepatic injury in one patient in group R. Conclusion Rabeprazole facilitated the healing process post-ESD.
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Affiliation(s)
- Hiroyuki Komori
- 1 Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan
| | - Hiroya Ueyama
- 1 Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan
| | - Akihito Nagahara
- 1 Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan
| | - Yoichi Akazawa
- 1 Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan
| | - Tsutomu Takeda
- 1 Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan
| | - Kohei Matsumoto
- 1 Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan
| | - Kenshi Matsumoto
- 1 Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan
| | - Daisuke Asaoka
- 1 Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan
| | - Mariko Hojo
- 1 Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan
| | - Takashi Yao
- 2 Department of Human Pathology, Juntendo University, School of Medicine, Tokyo, Japan
| | - Sumio Watanabe
- 1 Department of Gastroenterology, Juntendo University, School of Medicine, Tokyo, Japan
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He HS, Li BY, Chen QT, Song CY, Shi J, Shi B. Comparison of the Use of Vonoprazan and Proton Pump Inhibitors for the Treatment of Peptic Ulcers Resulting from Endoscopic Submucosal Dissection: A Systematic Review and Meta-Analysis. Med Sci Monit 2019; 25:1169-1176. [PMID: 30755541 PMCID: PMC6381807 DOI: 10.12659/msm.911886] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022] Open
Abstract
BACKGROUND Currently, proton pump inhibitors (PPIs) are the first-line treatment for ulcers resulting from endoscopic submucosal dissection (ESD). Vonoprazan is a new oral potassium-competitive acid blocker (P-CAB). The aim of this systematic review and meta-analysis was to compare the efficacy, safety, and tolerance of vonoprazan with PPIs in the treatment of peptic ulcers resulting from ESD. MATERIAL AND METHODS Published results of randomized clinical trials (RCTs) comparing vonoprazan with PPIs in the treatment of ulcers resulting from ESD were identified up to March 2018. The main clinical endpoints evaluated were healing rate and adverse events. The meta-analysis included quality assessment of the studies, statistical analysis of endpoints, and sensitivity analysis using Revman version 5.3 meta-analysis software. RESULTS Systematic literature review identified seven published studies that included 548 patients. Five studies were published as full-text manuscripts, and two studies were published as abstracts. Meta-analysis of the vonoprazan treatment, compared with PPI treatment, for ESD showed that the pooled relative risk (RR) of healing rate was 0.64 (95% CI, 0.33-1.22) for the 4-week study group and 0.98 (95% CI, 0.84-1.15) for the 8-week study group. The RR for adverse events was 0.65 (95% CI, 0.31-1.38) (P>0.05). No statistical evidence of publication bias was found. CONCLUSIONS The findings of the systematic review and meta-analysis showed that the efficacy of vonoprazan was comparable with PPIs for the treatment of peptic ulcers following ESD. Further studies are required to support the safety and efficacy of vonoprazan compared with different types of PPIs.
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Affiliation(s)
- Hui-Si He
- Naval Clinical Medicine Grade 2014, Basic Medical College, Second Military Medical University, Shanghai, China (mainland)
| | - Bing-Yang Li
- Naval Clinical Medicine Grade 2014, Basic Medical College, Second Military Medical University, Shanghai, China (mainland)
| | - Qi-Tong Chen
- Department of Emergency Medicine, Changzheng Hospital, Second Military Medical University, Shanghai, China (mainland)
| | - Chun-Yan Song
- Department of Pathology, Changhai Hospital, Second Military Medical University, Shanghai, China (mainland)
| | - Jian Shi
- Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai, China (mainland)
| | - Bin Shi
- Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai, China (mainland)
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Hamada K, Uedo N, Tonai Y, Arao M, Suzuki S, Iwatsubo T, Kato M, Shichijo S, Yamasaki Y, Matsuura N, Nakahira H, Kanesaka T, Yamamoto S, Akasaka T, Hanaoka N, Takeuchi Y, Higashino K, Ishihara R, Okada H, Iishi H, Fukui K, Shimokawa T. Efficacy of vonoprazan in prevention of bleeding from endoscopic submucosal dissection-induced gastric ulcers: a prospective randomized phase II study. J Gastroenterol 2019; 54:122-130. [PMID: 29943163 DOI: 10.1007/s00535-018-1487-6] [Citation(s) in RCA: 36] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/24/2018] [Accepted: 06/13/2018] [Indexed: 02/04/2023]
Abstract
BACKGROUND Vonoprazan, potassium-competitive acid blocker, is expected to reduce incidence of delayed bleeding after gastric endoscopic submucosal dissection (ESD); however, preliminary data to design a large-scale comparative study are lacking. This study aimed to assess the efficacy of vonoprazan in preventing delayed bleeding after gastric ESD. METHODS In this single-center randomized phase II trial, a modified screened selection design was used with a threshold non-bleeding rate of 89% and an expected rate of 97%. In this design, Simon's optimal two-stage design was first applied for each parallel group, and efficacy was evaluated in comparison with the threshold rate using binomial testing. Patients were randomly assigned in a 1:1 ratio to receive either vonoprazan 20 mg (VPZ group) or lansoprazole 30 mg (PPI group) for 8 weeks from the day before gastric ESD. The primary endpoint was the incidence of delayed bleeding, defined as endoscopically confirmed bleeding accompanied by hematemesis, melena, or a decrease in hemoglobin of ≥ 2 g/dl. RESULTS Delayed bleeding occurred in three of 69 patients (4.3%, 95% CI 0.9-12.2%, p = 0.047) in the VPZ group, and four of 70 (5.7%, 95% CI 1.6-14.0%, p = 0.104) in the PPI group. As only vonoprazan showed significant reduction in delayed bleeding compared with the threshold rate, it was determined to be efficacious treatment. CONCLUSIONS Vonoprazan efficaciously reduced the delayed bleeding rate in patients with an ESD-induced gastric ulcer. A large-scale, randomized, phase III study is warranted to definitively test the effectiveness of vonoprazan compared with proton pump inhibitors.
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Affiliation(s)
- Kenta Hamada
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Noriya Uedo
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan.
| | - Yusuke Tonai
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Masamichi Arao
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Sho Suzuki
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Taro Iwatsubo
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Minoru Kato
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Satoki Shichijo
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Yasushi Yamasaki
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Noriko Matsuura
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Hiroko Nakahira
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Takashi Kanesaka
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Sachiko Yamamoto
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Tomofumi Akasaka
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Noboru Hanaoka
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Yoji Takeuchi
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Koji Higashino
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Ryu Ishihara
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Hiroyuki Okada
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Hiroyasu Iishi
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Keisuke Fukui
- Department of Cancer Control and Statistics, Osaka International Cancer Institute, Osaka, Japan
| | - Toshio Shimokawa
- Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan
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Martin, Zhou Y, Meng CX, Takagi T, Tian YS. Vonoprazan versus proton pump inhibitors in treating post-endoscopic submucosal dissection ulcers and preventing bleeding: Protocol for meta-analysis of randomized controlled trials and observational studies. Medicine (Baltimore) 2019; 98:e14381. [PMID: 30813139 PMCID: PMC6408105 DOI: 10.1097/md.0000000000014381] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/09/2019] [Accepted: 01/14/2019] [Indexed: 12/11/2022] Open
Abstract
BACKGROUND Vonoprazan is a potassium-competitive acid blocker (P-CAB). It is often used in Japan for Helicobacter pylori (H pylori) eradication, gastroesophageal reflux disease, and endoscopic submucosal dissection (ESD) ulcers and bleeding. This meta-analysis aims to evaluate whether vonoprazan has better therapeutic effect on ESD-induced ulcers and bleeding than proton pump inhibitors (PPIs) at different length of treatment periods (2, 4, and 8 weeks). METHODS This meta-analysis will include both randomized controlled trials (RCTs) and observational studies discussing the effectiveness of vonoprazan and PPIs on ESD-induced ulcers and bleeding. Information of studies will be collected from PubMed, Cochrane Library, ClinicalTrials.gov, and Google Scholar. Studies will be selected according to the eligibility criteria and data will be extracted by 2 people and compared with each other to keep in consistency. Cochrane risk of bias tool will be used to assess RCTs and the Newcastle-Ottawa Quality Assessment Scale will be used to assess the observational studies. Meta-analysis based on the random-effects model will be conducted to compare the differences of ulcers' shrinkage ratios (%) and the odds ratios (OR) of scars' stages and delayed bleeding. Publication bias will be evaluated using funnel plots and Egger's regression test. Heterogeneity will be assessed with the I statistics. Sensitivity analysis will be conducted on follow-up periods. The evidential quality of the findings will be assessed with the Grading of Recommendations Assessment Development and Evaluation (GRADE) profiler. DISCUSSION The findings of the present systematic review will be critical for physicians, patients, and policymakers regarding the use of vonoprazan in ESD-induced ulcers. STUDY REGISTRATION PROSPERO registration number: CRD42018116855.
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Kakushima N, Ono H, Takizawa K, Tanaka M, Kawata N, Yoshida M, Murai K, Yabuuchi Y, Kishida Y, Ito S, Imai K, Hotta K, Ishiwatari H, Matsubayashi H. Incidence of Delayed Bleeding among Patients Continuing Antithrombotics during Gastric Endoscopic Submucosal Dissection. Intern Med 2019; 58:2759-2766. [PMID: 31582592 PMCID: PMC6815908 DOI: 10.2169/internalmedicine.2754-19] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/18/2022] Open
Abstract
objective In patients continuing antithrombotics, delayed bleeding after gastric endoscopic submucosal dissection (ESD) is a severe complication. Vonoprazan (VPZ) exerts a rapid, potent, and long-lasting antacid effect compared with traditional proton-pump inhibitors (PPIs). This study aimed to compare the incidence of delayed bleeding after gastric ESD between the use of VPZ and PPIs in patients continuing antithrombotics. Methods In this retrospective analysis, we examined 71 patients with 101 lesions treated with traditional PPIs (PPI group) and 59 patients with 90 lesions treated with VPZ (VPZ group). After 2 days (day 0 and 1) of intravenous PPI administration, either an oral PPI or VPZ was administered from postoperative day 2 to 8 weeks after ESD. We assessed the incidence of overall delayed bleeding as well as bleeding that occurred from day 2 until 8 weeks after ESD. Results There was no significant difference in the use of antithrombotic agents between the groups. Overall delayed bleeding occurred 13 times (18%) in 9 patients in the PPI group and 18 times (31%) in 17 patients in the VPZ group (p=0.10). Bleeding from day 2 until 8 weeks after ESD occurred 12 times (17%) in 9 patients in the PPI group and 8 times (14%) in 8 patients in the VPZ group. Conclusion Even with a potent antacid agent, such as VPZ, the incidence of delayed bleeding was high in patients undergoing ESD with continuous antithrombotic agents.
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Affiliation(s)
| | - Hiroyuki Ono
- Division of Endoscopy, Shizuoka Cancer Center, Japan
| | | | - Masaki Tanaka
- Division of Endoscopy, Shizuoka Cancer Center, Japan
| | - Noboru Kawata
- Division of Endoscopy, Shizuoka Cancer Center, Japan
| | - Masao Yoshida
- Division of Endoscopy, Shizuoka Cancer Center, Japan
| | | | | | | | - Sayo Ito
- Division of Endoscopy, Shizuoka Cancer Center, Japan
| | | | - Kinichi Hotta
- Division of Endoscopy, Shizuoka Cancer Center, Japan
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Vonoprazan versus proton-pump inhibitors for gastric endoscopic submucosal dissection-induced ulcers: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol 2018; 30:1416-1421. [PMID: 29985791 DOI: 10.1097/meg.0000000000001204] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
Acid secretion inhibitors are usually prescribed to promote the healing of artificial ulcers caused by endoscopic submucosal dissection (ESD) to reduce the risk of gastric perforation and delayed bleeding. Vonoprazan is a newer agent that has been shown to be more potent than a proton-pump inhibitor (PPI). However, it remains unclear whether vonoprazan is more effective than PPI in promoting healing of ulcers caused by ESD. Medline and Embase databases were searched through January 2018 for studies that compared the rate of complete healing of ulcers caused by ESD and post-ESD delayed bleeding in patients who received vonoprazan versus those who received PPI after ESD. Pooled odds ratio (OR) and 95% confidence interval (CI) were calculated using a random-effect model, generic inverse variance method. The between-study heterogeneity was quantified using the Q-statistic and I. A total of six studies consisting of 461 patients were identified. The likelihood that ulcers caused by ESD were completely healed at 4-8 weeks after the procedure was significantly higher among patients who received vonoprazan compared with those who received PPI, with a pooled OR of 2.27 (95% CI=1.38-3.73; I=0%). The risk of developing post-ESD delayed bleeding was also numerically lower among those who received vonoprazan, with a pooled OR of 0.79, although the result did not reach statistical significance (95% CI=0.18-3.49; I=29%). This study found that patients who received vonoprazan after ESD had a significantly higher rate of completely healed ulcers compared with those who received PPI.
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Sanomura Y, Oka S, Tanaka S, Yorita N, Kuroki K, Kurihara M, Mizumoto T, Yoshifuku Y, Chayama K. Taking Warfarin with Heparin Replacement and Direct Oral Anticoagulant Is a Risk Factor for Bleeding after Endoscopic Submucosal Dissection for Early Gastric Cancer. Digestion 2018; 97:240-249. [PMID: 29421806 DOI: 10.1159/000485026] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/13/2017] [Accepted: 11/07/2017] [Indexed: 02/04/2023]
Abstract
BACKGROUND Although bleeding after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC) remains problematic, especially in patients taking anticoagulants, there are differing views on the ideal and optimal management for these patients. This study investigated the risk of bleeding after ESD in patients taking anticoagulants. METHODS We enrolled 61 consecutive patients taking anticoagulants (anticoagulant group) and 968 patients taking no antithrombotic agents (non-antithrombotic group) treated with ESD for EGC between December 2010 and October 2016. We analyzed the risk factors for bleeding after ESD in relation to the various clinical factors. RESULTS Incidences of bleeding after ESD were significantly higher (14%; 11/76) in the anticoagulant group compared to the non-antithrombotic group (3%; 40/1,167). Moreover, bleeding after ESD was significantly more common in patients in the warfarin monotherapy group (14%; 5/37) and in the direct oral anticoagulant (DOAC) monotherapy group (22%; 4/18), compared to the non-antithrombotic group. Multivariate analysis revealed that dialysis, the use of anticoagulants, and an operation time ≥75 min were independent risk factors for bleeding after ESD. CONCLUSIONS Our data suggest that patients who take warfarin and receive heparin bridging, and those who take DOAC medication, are prone to bleeding after ESD for EGC.
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Affiliation(s)
- Yoji Sanomura
- Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan
| | - Shiro Oka
- Department of Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan
| | - Shinji Tanaka
- Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan
| | - Naoki Yorita
- Department of Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan
| | - Kazutaka Kuroki
- Department of Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan
| | - Mio Kurihara
- Department of Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan
| | - Takeshi Mizumoto
- Department of Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan
| | - Yoshikazu Yoshifuku
- Department of Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan
| | - Kazuaki Chayama
- Department of Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan
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Bang CS, Shin WG, Seo SI, Choi MH, Jang HJ, Park SW, Kae SH, Yang YJ, Shin SP, Baik GH, Kim HY. Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study. Surg Endosc 2018; 33:1376-1385. [PMID: 30167954 DOI: 10.1007/s00464-018-6412-9] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2018] [Accepted: 08/24/2018] [Indexed: 12/13/2022]
Abstract
BACKGROUND The optimal treatment regimen or the duration of treatment for an endoscopic submucosal dissection (ESD)-induced gastric ulcer has not been established. The aim of this study was to assess the efficacy of novel proton-pump inhibitor, ilaprazole, for the treatment of ESD-induced gastric ulcer. METHODS This was a prospective, open-label, randomized multicenter study. Between June 2015 and March 2018, a total of 176 patients (178 lesions) who underwent ESD for a gastric neoplasm were randomly allocated to receive the oral proton-pump inhibitor ilaprazole 20 mg or rabeprazole 20 mg daily for 8 weeks. The primary outcome was the ulcer healing rate at 4 and 8 weeks. RESULTS A total of 155 (157 lesions) and 154 patients (156 lesions) were included in the modified intention-to-treat (mITT) and per-protocol analyses, respectively. There was no significant difference in the ulcer healing rate (ilaprazole vs. rabeprazole, 97.4% vs. 97.0 p = 0.78 at 4 weeks, 100% vs. 100%, p = 0.95 at 8 weeks in the mITT analysis) or stage of ulcer (scar stage, 25.6% vs. 17.7%, p = 0.25 at 4 weeks, 92.3% vs. 88.6%, p = 0.59 at 8 weeks in the mITT analysis) between the treatment groups. The quality of ulcer healing was not significantly different between the two groups. No independent predictive factor for higher-quality ulcer healing was found in the multivariate analysis. CONCLUSIONS According to this trial, ilaprazole and rabeprazole showed no significant difference in the healing of artificial gastric ulcers. Most of the ulcers achieved complete healing within 4-8 weeks. TRIAL REGISTRATION ClinicalTrial.gov NCT02638584.
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Affiliation(s)
- Chang Seok Bang
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea.,Institue of New Frontier Research, Hallym University College of Medicine, Chuncheon, South Korea
| | - Woon Geon Shin
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea. .,Division of Gastroenterology, Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, 150 Seongan-ro, Gangdong-gu, Seoul, 05355, South Korea.
| | - Seung In Seo
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Min Ho Choi
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Hyun Joo Jang
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Se Woo Park
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Sea Hyub Kae
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Young Joo Yang
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Suk Pyo Shin
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Gwang Ho Baik
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
| | - Hak Yang Kim
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, South Korea
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Yamasaki A, Yoshio T, Muramatsu Y, Horiuchi Y, Ishiyama A, Hirasawa T, Tsuchida T, Sasaki Y, Fujisaki J. Vonoprazan is Superior to Rabeprazole for Healing Endoscopic Submucosal Dissection: Induced Ulcers. Digestion 2018; 97:170-176. [PMID: 29310111 DOI: 10.1159/000485028] [Citation(s) in RCA: 23] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/07/2017] [Accepted: 11/07/2017] [Indexed: 02/04/2023]
Abstract
BACKGROUND AND AIMS Endoscopic submucosal dissection (ESD) is a well-established minimally invasive treatment for early gastric cancer. To heal ESD-induced ulcers, we commonly prescribe proton pump inhibitors (PPIs). Vonoprazan is our new choice, which is reported to have a stronger and longer acid inhibitory effect than existing PPIs. Here, we aimed to evaluate the efficacy of vonoprazan for healing ESD-induced ulcers compared with rabeprazole. METHODS We reviewed 190 patients who underwent ESD before and after we switched the acid secretion inhibitor from rabeprazole to vonoprazan. We evaluated scarring and reduction rates at 4 weeks after ESD. RESULTS Scarring rates were not different between vonoprazan and rabeprazole (31.7 vs. 18.9%; p = 0.07). However, for ulcers ≤35 mm, vonoprazan was superior to rabeprazole (42.2 vs. 19.2%; p < 0.05). Reduction rates were superior for vonoprazan compared with rabeprazole (93.0 vs. 90.4%; p < 0.05). In multivariate analysis, vonoprazan was superior to rabeprazole for ulcer scarring (OR 2.21; p < 0.05), and ulcer location in the lower-third of the stomach had higher risk of incomplete scarring (OR 0.37; p < 0.05). CONCLUSION Vonoprazan was superior to rabeprazole for healing ESD-induced ulcers.
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Affiliation(s)
- Akira Yamasaki
- Department of Gastroenterology, Cancer Institute Hospital, Tokyo, Japan.,Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan
| | - Toshiyuki Yoshio
- Department of Gastroenterology, Cancer Institute Hospital, Tokyo, Japan
| | - Yusuke Muramatsu
- Department of Gastroenterology, Cancer Institute Hospital, Tokyo, Japan
| | - Yusuke Horiuchi
- Department of Gastroenterology, Cancer Institute Hospital, Tokyo, Japan
| | - Akiyoshi Ishiyama
- Department of Gastroenterology, Cancer Institute Hospital, Tokyo, Japan
| | - Toshiaki Hirasawa
- Department of Gastroenterology, Cancer Institute Hospital, Tokyo, Japan
| | - Tomohiro Tsuchida
- Department of Gastroenterology, Cancer Institute Hospital, Tokyo, Japan
| | - Yutaka Sasaki
- Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan
| | - Junko Fujisaki
- Department of Gastroenterology, Cancer Institute Hospital, Tokyo, Japan
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Otsuka T, Sugimoto M, Ban H, Nakata T, Murata M, Nishida A, Inatomi O, Bamba S, Andoh A. Severity of gastric mucosal atrophy affects the healing speed of post-endoscopic submucosal dissection ulcers. World J Gastrointest Endosc 2018; 10:83-92. [PMID: 29774087 PMCID: PMC5955726 DOI: 10.4253/wjge.v10.i5.83] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/30/2018] [Revised: 03/04/2018] [Accepted: 03/20/2018] [Indexed: 02/06/2023] Open
Abstract
AIM To investigate factors associated with the healing of endoscopic submucosal dissection (ESD)-induced ulcers. METHODS We enrolled 132 patients with gastric tumors scheduled for ESD. Following ESD, patients were treated with daily lansoprazole 30 mg or vonoprazan 20 mg. Ulcer size was endoscopically measured on the day after ESD and at 4 and 8 wk. The gastric mucosa was endoscopically graded according to the Kyoto gastritis scoring system. We assessed the number of patients with and without a 90% reduction in ulcer area at 4 wk post-ESD and scar formation at 8 wk, and looked for risk factors for slower healing. RESULTS The mean size of gastric tumors and post-ESD ulcers was 17.4 ± 12.1 mm and 32.9 ± 13.0 mm. The mean reduction rates in ulcer area were 90.4% ± 0.8% at 4 wk and 99.8% ± 0.1% at 8 wk. The reduction rate was associated with the Kyoto grade of gastric atrophy at 4 wk (A0: 97.9% ± 0.6%, A1: 93.4% ± 4.1%, and A2: 89.7% ± 1.0%, respectively). In multivariate analysis, the factor predicting 90% reduction at 4 wk was gastric atrophy (Odds ratio: 5.678, 95%CI: 1.190-27.085, P = 0.029). CONCLUSION The healing speed of post-ESD ulcers was associated with the degree of gastric mucosal atrophy, and Helicobacter pylori eradication therapy is required to perform at younger age.
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Affiliation(s)
- Taketo Otsuka
- Division of Digestive Endoscopy, Shiga University of Medical Science Hospital, Otsu 520-2192, Japan
| | - Mitsushige Sugimoto
- Division of Digestive Endoscopy, Shiga University of Medical Science Hospital, Otsu 520-2192, Japan
| | - Hiromitsu Ban
- Division of Digestive Endoscopy, Shiga University of Medical Science Hospital, Otsu 520-2192, Japan
| | - Toshiro Nakata
- Department of Gastroenterology, Shiga University of Medical Science Hospital, Otsu 520-2192, Japan
| | - Masaki Murata
- Department of Gastroenterology, Shiga University of Medical Science Hospital, Otsu 520-2192, Japan
| | - Atsushi Nishida
- Department of Gastroenterology, Shiga University of Medical Science Hospital, Otsu 520-2192, Japan
| | - Osamu Inatomi
- Department of Gastroenterology, Shiga University of Medical Science Hospital, Otsu 520-2192, Japan
| | - Shigeki Bamba
- Department of Gastroenterology, Shiga University of Medical Science Hospital, Otsu 520-2192, Japan
| | - Akira Andoh
- Department of Gastroenterology, Shiga University of Medical Science Hospital, Otsu 520-2192, Japan
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Comparison of the Effects of Vonoprazan and Lansoprazole for Treating Endoscopic Submucosal Dissection-Induced Artificial Ulcers. Dig Dis Sci 2018; 63:974-981. [PMID: 29464587 DOI: 10.1007/s10620-018-4948-0] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/29/2017] [Accepted: 01/23/2018] [Indexed: 02/06/2023]
Abstract
BACKGROUND Vonoprazan exhibits a more potent, rapid, and longer-lasting inhibitory effect on gastric acid secretion than proton pump inhibitors; however, whether it is more effective than PPI for treating endoscopic submucosal dissection (ESD)-induced artificial ulcers remains controversial. AIM This study aimed to assess and compare the effects of vonoprazan and lansoprazole for treating ESD-induced artificial ulcers. METHODS This prospective, randomized controlled trial enrolled 149 patients who underwent ESD for the treatment of early gastric neoplasms from April 2015 to May 2017. They were randomly treated with either 20 mg/day vonoprazan (V group) or 30 mg/day lansoprazole (L group) orally. The primary end points were the area and shrinkage ratio of the ulcers at 4 and 8 weeks post-ESD. RESULTS Data from 127 patients were analyzed, which showed that the 4- and 8-week healing ratios were not significantly different between the V and L groups (4 weeks, 16.3 vs. 25.8%; 8 weeks, 86.9 vs. 90.9%, respectively). Similarly, the shrinkage ratio, categorized as less than 90%, 90% or more but less than 100%, or 100% at 4 weeks and as less than 100% or 100% at 8 weeks were not statistically different between the V and L groups (4 weeks: 12, 41, 8 vs. 13, 41, 12, p = 0.7246; 8 weeks: 9, 52 vs. 9, 57, p = 0.8568). Delayed bleeding was also not significantly different between both the groups (5.4 vs. 5.3%; p = 0.9844). CONCLUSIONS Vonoprazan is as effective as lansoprazole in treating ESD-induced ulcers.
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Feasibility of Autologous Fibrin Glue and Polyglycolic Acid Sheets to Prevent Delayed Bleeding after Endoscopic Submucosal Dissection of Gastric Neoplasms in Patients Receiving Antithrombotic Therapy. Gastroenterol Res Pract 2018; 2018:2174957. [PMID: 29686700 PMCID: PMC5857318 DOI: 10.1155/2018/2174957] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/23/2017] [Revised: 01/24/2018] [Accepted: 01/28/2018] [Indexed: 12/11/2022] Open
Abstract
Background/Aims Delayed bleeding is one of the most serious complications following gastric endoscopic submucosal dissection (ESD) under antithrombotic therapy. As a safety measure, for patients receiving antithrombotic therapy, we covered the ESD ulcer with autologous fibrin glue (prepared using autologous blood) alone or with polyglycolic acid (PGA) sheets. Methods From July 2014 to November 2015, 20 patients with gastric neoplasms who were receiving antithrombotic therapy were enrolled in this study. After ESD, the ESD ulcers were covered with autologous fibrin glue alone or with PGA sheets. We prospectively evaluated the feasibility of this safety measure. Results In total, 22 lesions in 20 patients were resected en bloc by ESD. The mean specimen size and tumor size were 31.5 ± 9.5 mm and 14.0 ± 8.8 mm, respectively. There were no cases of delayed bleeding or adverse events in this study. Attachment of autologous fibrin glue was observed in 81.8% (18/22) and 68.2% (15/22) of lesions at endoscopy performed 1 day and 7 days after ESD, respectively. Conclusion No patient in this study had delayed bleeding or adverse events. This suggests that this measure may facilitate the safety of gastric ESD in patients receiving antithrombotic therapy. This trial is registered with UMIN000019386.
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35
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Effects of Vonoprazan Compared with Esomeprazole on the Healing of Artificial Postendoscopic Submucosal Dissection Ulcers: A Prospective, Multicenter, Two-Arm, Randomized Controlled Trial. Gastroenterol Res Pract 2018; 2018:1615092. [PMID: 29670650 PMCID: PMC5835268 DOI: 10.1155/2018/1615092] [Citation(s) in RCA: 23] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/03/2017] [Accepted: 12/06/2017] [Indexed: 12/14/2022] Open
Abstract
Background Vonoprazan affords more clinical benefits than proton pump inhibitors (PPIs) during the healing of gastroduodenal ulcers. However, it remains controversial whether vonoprazan is more effective than PPIs when used to heal artificial ulcers arising after endoscopic submucosal dissection (ESD). Aim This study investigated the effects of vonoprazan compared with esomeprazole on the healing of post-ESD artificial ulcers. Methods Sixty patients who underwent gastric ESD between May 2015 and May 2017 were randomized to treatment with vonoprazan (V group) or esomeprazole (E group) for 8 weeks. Upper endoscopy was performed at 4 and 8 weeks after ESD, and drug effects were estimated based on the ulcer healing rates and shrinkage rates. Results Fifty-three patients were analyzed. The respective 4- and 8-week ulcer healing rates did not differ significantly between V and E groups (8.0 versus 11.5%, P = 0.669; 88.9 versus 84.6%, P = 0.420). Similarly, the respective 4- and 8-week ulcer shrinkage rates did not differ significantly between V and E groups (96.8 versus 97.5%, P = 0.656; 100 versus 100%, P = 0.257). Conclusion The healing of artificial ulcers after ESD did not differ using vonoprazan or esomeprazole. Both vonoprazan and esomeprazole were effective when used to promote artificial ulcer healing after ESD.
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Yang X, Li Y, Sun Y, Zhang M, Guo C, Mirza IA, Li YQ. Vonoprazan: A Novel and Potent Alternative in the Treatment of Acid-Related Diseases. Dig Dis Sci 2018; 63:302-311. [PMID: 29282636 DOI: 10.1007/s10620-017-4866-6] [Citation(s) in RCA: 42] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/08/2017] [Accepted: 11/21/2017] [Indexed: 12/12/2022]
Abstract
Although proton pump inhibitors (PPIs) have been used widely, acid-related diseases are still associated with a huge burden on the health care system. Recently, the efficacy and safety of a new acid suppressant named vonoprazan in the treatment of acid-related diseases have been evaluated by a series of studies. As a novel potassium-competitive acid blocker, vonoprazan may provide reversible acid suppression by preventing K+ from binding to gastric H+/K+-ATPase. It has been clinically used for the short-term treatment of gastroesophageal reflux disease (GERD), peptic ulcer disease and Helicobacter pylori (H. pylori) infection in Japan. The healing rate of GERD and gastric ulcers by vonoprazan is more than 95 and 90%, respectively; also, it is effective in curing PPI-resistant GERD. It increases H. pylori eradication rate to more than 88% as part of both first-line and second-line therapy. It is also effective in the eradication of clarithromycin-resistant H. pylori strains. All of these short-term studies show vonoprazan is safe and well-tolerated. As a safe and effective acid inhibitor, vonoprazan might be a novel alternative in the treatment of acid-related diseases.
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Affiliation(s)
- Xiaoxiao Yang
- Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, 107 Wenhuaxi Road, Jinan, 250012, Shandong Province, China
| | - Yueyue Li
- Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, 107 Wenhuaxi Road, Jinan, 250012, Shandong Province, China
| | - Yiyuan Sun
- Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, 107 Wenhuaxi Road, Jinan, 250012, Shandong Province, China
| | - Mingming Zhang
- Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, 107 Wenhuaxi Road, Jinan, 250012, Shandong Province, China
| | - Chuanguo Guo
- Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, 107 Wenhuaxi Road, Jinan, 250012, Shandong Province, China
| | - Iqtida Ahmed Mirza
- Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, 107 Wenhuaxi Road, Jinan, 250012, Shandong Province, China
| | - Yan-Qing Li
- Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, 107 Wenhuaxi Road, Jinan, 250012, Shandong Province, China.
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Horikawa Y, Mizutamari H, Mimori N, Kato Y, Fushimi S, Sato S, Okubo S. Short-term efficacy of potassium-competitive acid blocker following gastric endoscopic submucosal dissection: a propensity score analysis. Scand J Gastroenterol 2018; 53:243-251. [PMID: 29214885 DOI: 10.1080/00365521.2017.1410569] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
BACKGROUND Endoscopic submucosal dissection (ESD) is a promising method for the resection of superficial gastric neoplasms. Vonoprazan is a novel potassium-competitive acid blocker (P-CAB) that is currently considered as a potential alternative to proton pump inhibitors (PPIs) for the treatment of acid-related diseases. However, the utility of vonoprazan in ESD-related ulcers is unclear. Therefore, we compared the short-term efficacies of vonoprazan and the PPI lansoprazole in ESD-related ulcer healing during the first two weeks following intervention. METHODS This study included 115 superficial gastric neoplasms that were treated by ESD at Hiraka General Hospital between April 2015 and January 2017. Patients treated with P-CAB (20 mg vonoprazan, n = 62) or PPI (30 mg lansoprazole, n = 53) were compared using propensity-score matching analysis. Primary outcome was rate of ulcer reduction at two weeks after ESD. Secondary outcomes were coverage ratio of ulcer base by granulation tissue and incidence of postoperative bleeding. RESULTS The rate of ulcer reduction was significantly higher (median [range], 80.6% [67.6%-94.5%] vs. 62.7% [33.4%-85.2%]; p < .0001) and coverage ratio of the ulcer base by granulation tissue was significantly accelerated (median [range], 84.1% [67.7%-95.3%] vs. 61.9% [12.1%-90.1%]; P < 0.0001) in the P-CAB group compared with the PPI group. Postoperative bleeding was not observed in either group. CONCLUSIONS P-CAB achieved rapid artificial ulcer healing with promotion of granulation tissue formation. However, conventional PPI with initial intravenous infusion might be sufficient for prevention of postoperative bleeding following gastric ESD.
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Affiliation(s)
- Yohei Horikawa
- a Department of Gastroenterology , Hiraka General Hospital , Yokote Akita , Japan
| | - Hiroya Mizutamari
- a Department of Gastroenterology , Hiraka General Hospital , Yokote Akita , Japan
| | - Nobuya Mimori
- a Department of Gastroenterology , Hiraka General Hospital , Yokote Akita , Japan
| | - Yuhei Kato
- a Department of Gastroenterology , Hiraka General Hospital , Yokote Akita , Japan
| | - Saki Fushimi
- a Department of Gastroenterology , Hiraka General Hospital , Yokote Akita , Japan
| | - Sayaka Sato
- a Department of Gastroenterology , Hiraka General Hospital , Yokote Akita , Japan
| | - Syunji Okubo
- a Department of Gastroenterology , Hiraka General Hospital , Yokote Akita , Japan
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Suzuki N, Hiraga J, Takagi Y, Tsuzuki T, Uematsu N, Kagami Y. Immune thrombocytopenia induced by vonoprazan fumarate: a single center retrospective study. Ann Hematol 2017; 97:741-742. [PMID: 29247400 DOI: 10.1007/s00277-017-3206-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/16/2017] [Accepted: 12/05/2017] [Indexed: 10/18/2022]
Affiliation(s)
- Naruko Suzuki
- Department of Hematology, Toyota Kosei Hospital, 500-1, Ibobara, Josui-cho, Toyota City, 470-0396, Japan.
| | - Junji Hiraga
- Department of Hematology, Toyota Kosei Hospital, 500-1, Ibobara, Josui-cho, Toyota City, 470-0396, Japan
| | - Yusuke Takagi
- Department of Hematology, Toyota Kosei Hospital, 500-1, Ibobara, Josui-cho, Toyota City, 470-0396, Japan
| | - Tomoyuki Tsuzuki
- Department of Gastroenterology, Toyota Kosei Hospital, Toyota, Japan
| | - Natsuko Uematsu
- Department of Pharmacology, Toyota Kosei Hospital, Toyota, Japan
| | - Yoshitoyo Kagami
- Department of Hematology, Toyota Kosei Hospital, 500-1, Ibobara, Josui-cho, Toyota City, 470-0396, Japan
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Ono S, Myojo M, Harada H, Tsuji K, Murakami D, Suehiro S, Doyama H, Ando J, Saito I, Fujishiro M, Komuro I, Koike K. Is it possible to perform gastric endoscopic submucosal dissection without discontinuation of a single antiplatelet of thienopyridine derivatives? Endosc Int Open 2017; 5:E943-E949. [PMID: 28924604 PMCID: PMC5597936 DOI: 10.1055/s-0043-116381] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/04/2017] [Accepted: 06/14/2017] [Indexed: 02/08/2023] Open
Abstract
BACKGROUND AND STUDY AIMS Combined use of thienopyridine derivatives and other antithrombotic agents is reported to be a risk factor for postoperative bleeding after gastric endoscopic submucosal dissection (ESD). However, risk associated with a single thienopyridine derivative has not been evaluated. In this study, we aimed to evaluate bleeding risks of gastric ESD without discontinuation of a single thienopyridine derivative agent. PATIENTS AND METHODS This multicenter, prospective, observational cohort study included patients who had undergone implantation of a coronary artery stent and who were taking a combination of aspirin antiplatelet therapy and a thienopyridine derivative agent. Enrolled patients discontinued aspirin and underwent gastric ESD without the discontinuation of a single thienopyridine derivative agent. The primary endpoint was the major bleeding complication rate after gastric ESD. RESULTS Eleven patients were enrolled in this study from April 2015 to November 2016 after written informed consent was obtained. Among them, 1 patient, who had undergone surgery for a primary cardiac tumor before ESD, was excluded from the study. Ten patients underwent gastric ESD for neoplasms. En-bloc resections were achieved in all cases without intraoperative bleeding complications. Two patients experienced postoperative bleeding although neither case required a blood transfusion (95 % CI 2.5 - 55.6 %). CONCLUSION En-bloc resections were possible although the postoperative bleeding rate tended to be higher in gastric ESD without discontinuation of a single thienopyridine derivative agent. Additional preventive measures are mandatory to carry out safe gastric ESD in such settings.
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Affiliation(s)
- Satoshi Ono
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
| | - Masahiro Myojo
- Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
| | - Hideaki Harada
- Department of Gastroenterology, New Tokyo Hospital, Chiba, Japan
| | - Kunihiro Tsuji
- Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan
| | - Daisuke Murakami
- Department of Gastroenterology, New Tokyo Hospital, Chiba, Japan
| | - Satoshi Suehiro
- Department of Gastroenterology, New Tokyo Hospital, Chiba, Japan
| | - Hisashi Doyama
- Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan
| | - Jiro Ando
- Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
| | - Itaru Saito
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
| | - Mitsuhiro Fujishiro
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
- Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Issei Komuro
- Department of Cardiovascular Medicine, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
| | - Kazuhiko Koike
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
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Tsuchiya I, Kato Y, Tanida E, Masui Y, Kato S, Nakajima A, Izumi M. Effect of vonoprazan on the treatment of artificial gastric ulcers after endoscopic submucosal dissection: Prospective randomized controlled trial. Dig Endosc 2017; 29:576-583. [PMID: 28267236 DOI: 10.1111/den.12857] [Citation(s) in RCA: 48] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/13/2017] [Accepted: 03/01/2017] [Indexed: 12/26/2022]
Abstract
BACKGROUND AND AIM Proton pump inhibitors are effective for the treatment of gastric ulcers after endoscopic submucosal dissection (ESD). However, the most excellent therapy is controversial. Vonoprazan, an active potassium-competitive acid blocker, has a strong gastric acid secretion inhibitory effect, but its efficacy for the treatment of post-ESD gastric ulcers is unclear. Herein, we aimed to determine the healing effect of vonoprazan on post-ESD gastric ulcers. METHODS We carried out a prospective randomized controlled trial examining 92 patients who had undergone ESD for the treatment of gastric neoplasms between April 2015 and June 2016 at Machida Municipal Hospital. Patients were treated with 20 mg/day vonoprazan (V group) or 20 mg/day esomeprazole (E group) for 8 weeks. We evaluated the 8-week cure rate for artificial ulcers and any complications after ESD. RESULTS A total of 80 patients (median age, 73.5 years; 71.3% male) were analyzed. Cure rate for the V group was significantly higher than that for the E group (94.9% [37/39] vs 78.0% [32/41], respectively; P = 0.049). In a multivariate analysis, only vonoprazan was correlated with ulcer healing (odds ratio = 6.33; 95% CI = 1.21-33.20; P = 0.029). Delayed bleeding was experienced only in the E group (7.3% [3/41]), but no significant difference compared with the V group was observed (P = 0.241). CONCLUSION Vonoprazan was significantly superior to esomeprazole for the healing of post-ESD gastric ulcers and should be considered as a treatment of first choice.
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Affiliation(s)
- Izumi Tsuchiya
- Department of Gastroenterology, Machida Municipal Hospital, Tokyo, Japan.,Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan
| | - Yuri Kato
- Department of Gastroenterology, Machida Municipal Hospital, Tokyo, Japan
| | - Emiko Tanida
- Department of Gastroenterology, Machida Municipal Hospital, Tokyo, Japan
| | - Yoshifumi Masui
- Department of Gastroenterology, Machida Municipal Hospital, Tokyo, Japan
| | - Shingo Kato
- Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan
| | - Atsushi Nakajima
- Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, Yokohama, Japan
| | - Motoyoshi Izumi
- Department of Gastroenterology, Machida Municipal Hospital, Tokyo, Japan
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