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Mu X, Fan Y, Xu J, Xie R. Exploration of the optimal regimen of gastric mucosal cleansing medication for the H. pylori population before ME-NBI screening: study protocol for a single-center, single-blind, randomized controlled trial. Front Med (Lausanne) 2025; 12:1516271. [PMID: 40241907 PMCID: PMC12000017 DOI: 10.3389/fmed.2025.1516271] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/30/2024] [Accepted: 03/17/2025] [Indexed: 04/18/2025] Open
Abstract
Objective Magnifying endoscopy combined with narrow-band imaging endoscopy is an emerging method for early gastric cancer screening and diagnosis However, its effectiveness is closely related to the cleaning quality of the gastric mucosal preparation. H. pylori infection is a major risk factor for inadequate gastric mucosa cleaning quality preparation. Multiple medications are useful in helping patients with gastric mucosal cleansing preparations. This randomized controlled trial study protocol aims to investigate the effect of different combinations of medications on the quality of gastric mucosal cleansing in an H. pylori-infected population. Methods This study is a prospective, randomized, single-blind, single-center trial. The subjects are patients who require magnifying endoscopy combined with narrow-band imaging and have evidence of H. pylori infection (a non-invasive diagnostic 13C urea breath test was used to examine the study subjects). These patients will be randomly assigned to the control group (Group A) and the experimental groups (Groups B, C, D, E, and F). Each group will consist of 44 patients, with a total of 264 patients expected to be enrolled. The core content of the drug preparation regimen for each group is as follows: Group A (control group) will take 10 ml of simethicone before the examination; Group B (experimental group) will take 20,000 units of pronase before the examination; Group C (experimental group) will take 600 mg of N-acetylcysteine before the examination; Group D (experimental group) will take 10 ml of simethicone +20,000 units of pronase before the examination; Group E (experimental group) will take 10 ml of simethicone + 600 mg of N-acetylcysteine before the examination; Group F (experimental group) will take 10 ml of simethicone + 20,000 units of pronase + 1 g of sodium bicarbonate before the examination. All group medications will be dissolved in 50 ml of warm water at 20-40°C. All patients will fast for ≥6 h and abstain from drinking for 2 h before the examination. The primary endpoint is the gastric mucosa cleanliness score. Secondary endpoints include the early detection rate of gastric cancer, polyp detection rate, adenoma detection rate, procedure time, number of irrigations, patient medication compliance, preoperative anxiety, incidence of adverse reactions, overall patient satisfaction, and willingness to undergo the examination again. Implications The results of this research project are aimed at improving the quality of gastric mucosal cleansing preparations in the H. pylori population to meet the demand for early diagnosis and treatment prevention screening for early gastric cancer screening. The implementation of the results of the study and their inclusion in the guidelines may reduce economic expenditures by reflecting a reduced need for social and health care services. Clinical Trial registration Chinese Clinical Trial Registry (ChiCTR). Number of identification: (ChiCTR2400087510).
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Affiliation(s)
- Xinyi Mu
- Department of Nursing, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China
| | - Yi Fan
- Department of Endoscopy, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China
| | - Jingyu Xu
- Nursing College, Zunyi Medical University, Zunyi, Guizhou, China
| | - Rui Xie
- Department of Endoscopy and Digestive System, Guizhou Provincial People's Hospital, Guiyang, Guizhou, China
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Kong QZ, Peng C, Li Z, Tian BL, Li YY, Chen FX, Zuo XL, Li YQ. Inadequate gastric preparation and its associated factors for magnetically controlled capsule endoscopy. Front Pharmacol 2023; 14:1184754. [PMID: 37701026 PMCID: PMC10493275 DOI: 10.3389/fphar.2023.1184754] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/12/2023] [Accepted: 08/14/2023] [Indexed: 09/14/2023] Open
Abstract
Goals: To explore factors associated with inadequate gastric preparation for MCE. Background: Factors associated with inadequate gastric preparation for magnetically controlled capsule endoscopy (MCE) remains unclear. Study: Data of patients who underwent MCE from June 2021 to July 2022 were prospectively collected. The gastric cleanliness score (GCS) of the six stomach regions (gastric cardia, fundus, body, angulus, antrum, and pylorus) was recorded. Patients with GCS score ≥18 were defined as the adequate preparation. Factors related to inadequate gastric preparation were analyzed using a logistic regression model with estimated odds ratios (OR). Results: The mean GCS score of 211 patients was 17.01 ± 2.82. In the multivariable analysis, proton pump inhibitor (PPI) use (OR 3.57; 95% CI 1.69-7.95; p < 0.01) and premedication time after administering simethicone <30 min (OR 2.86; 95% CI 1.10-7.39; p = 0.03) were independent risk factors for inadequate gastric preparation. Comparing the gastric cleanliness of different locations, the median GCS of the lower stomach [10.00, IQR (9.50, 11.00)] was significantly higher than that of the upper stomach [7.00, IQR (6.00, 8.00)] (p <0.001). Conclusion: PPI use and inadequate premedication time (<30 min) may reduce the quality of gastric preparation for MCE. The type, dose, duration of medication, and discontinuation time of PPIs was well worth further exploration. Appropriate control of the type and time of premedication may be the key to improving overall gastric cleanliness.
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Affiliation(s)
- Qing-Zhou Kong
- Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China
| | - Cheng Peng
- Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China
| | - Zhen Li
- Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China
| | - Bao-Ling Tian
- Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China
| | - Yue-Yue Li
- Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China
| | - Fei-Xue Chen
- Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Jinan, Shandong, China
- Robot Engineering Laboratory for Precise Diagnosis and Therapy of GI Tumor, Qilu Hospital, Shandong University, Jinan, Shandong, China
| | - Xiu-Li Zuo
- Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Jinan, Shandong, China
- Robot Engineering Laboratory for Precise Diagnosis and Therapy of GI Tumor, Qilu Hospital, Shandong University, Jinan, Shandong, China
| | - Yan-Qing Li
- Department of Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China
- Shandong Provincial Clinical Research Center for Digestive Disease, Jinan, Shandong, China
- Robot Engineering Laboratory for Precise Diagnosis and Therapy of GI Tumor, Qilu Hospital, Shandong University, Jinan, Shandong, China
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Fuentes-Valenzuela E, Pérez-Arenas E, de Benito Sanz M, Chavarría C, Miguel Peña A, Carbajo López A, Tejedor-Tejada J, Burgueño Gómez B, Sánchez-Ocaña R, Albillos-Blanco M, Salvador de Las Heras A, García-Alonso FJ. Prospective cohort study to evaluate premedication with simethicone and n-acetilcysteine for upper diagnostic gastrointestinal endoscopy. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2023; 115:10-15. [PMID: 35297256 DOI: 10.17235/reed.2022.8576/2022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
INTRODUCTION The use of premedication for upper gastrointestinal endoscopy (UGE) is not widely established in western countries. The primary aim of the study was to compare gastric visibility according to the total visibility score (TVS). The secondary aim was to assess complications, diagnostic yield, endoscopic procedure time, sedation dose and patient satisfaction. METHODS A single center prospective cohort study was performed of consecutive adults undergoing an UGE in the afternoon working shift. After completing enrolment in the control group, patients were administered 200 mg simethicone and 500 mg N-acetylcysteine diluted in 100 ml of water >15 minutes before the procedure. All procedures were recorded and a single, blinded endoscopist evaluated the TVS after recruitment of both cohorts. Patient satisfaction was evaluated using the Spanish translation of the American Society of Gastrointestinal Endoscopy satisfaction questionnaire. RESULTS 205 patients were included in the study, 103 females (50.2%) with a median age of 54.8-years (IQR: 41.2-65.2). 104 were enrolled to the control group and 101 to the intervention group. Patients receiving premedication presented a higher rate of adequate (74.3% vs 45.2; difference 95% CI: 16,3-41,9%, p<0.001) and excellent gastric visibility (23.8% vs 7.7%; difference 95% CI: 6,3-25,8%, p=0.002). Propofol dose was similar, although the median procedure time was lower in the group of no intervention [5 (IQR: 4-7) vs 6 minutes (IQR: 5-7); p=0.03]. Procedure related adverse events were similar, except that patient without premedication experienced more nausea episodes. Major and minor endoscopic findings and the satisfaction questionnaire showed no differences between both groups. CONCLUSION Patients receiving premedication with simethicone and N-acetylcysteine had a better gastric visibility score, without any increase in adverse events or affecting the patients' satisfaction.
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Affiliation(s)
| | | | - Marina de Benito Sanz
- Endoscopy Unit, Gastroenterology Department, Hospital Universitario Río Hortega, Spain
| | - Carlos Chavarría
- Endoscopy Unit, Gastroenterology Department, Hospital Universitario Río Hortega, Spain
| | - Aleida Miguel Peña
- Endoscopy Unit, Gastroenterology Department, Hospital Universitario Río Hortega, Spain
| | - Ana Carbajo López
- Endoscopy Unit, Gastroenterology department. , Hospital Universitario Río Hortega, Spain
| | - Javier Tejedor-Tejada
- Endoscopy Unit, Gastroenterology Department, Hospital Universitario Río Hortega, Spain
| | | | - Ramon Sánchez-Ocaña
- Endoscopy Unit, Gastroenterology Department, Hospital Universitario Río Hortega, Spain
| | - María Albillos-Blanco
- Endoscopy Unit, Gastroenterology Department, Hospital Universitario Río Hortega, Spain
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Duez L, Gkolfakis P, Bastide M, Vuckovic C, Musala C, Van Gossum M, Hoyois A, Mulkay JP, Eisendrath P. Premedication with simethicone for improving the quality of gastric mucosal visualization: a double-blind randomized controlled trial. Endosc Int Open 2022; 10:E1343-E1349. [PMID: 36262507 PMCID: PMC9576330 DOI: 10.1055/a-1922-7773] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/27/2022] [Accepted: 07/26/2022] [Indexed: 11/21/2022] Open
Abstract
Background and study aims Saliva, bubbles, or mucus can limit gastric mucosal visualization (GMV), increasing the risk of missed lesions such as gastric cancer. Several studies using endoscopy photodocumentation-based scores have reported increased quality of GMV when mucolytic and/or defoaming agents are administered. This single-center, prospective, double-blind, randomized, placebo-controlled trial aimed to evaluate whether simethicone administration could improve GMV. Patients and methods Patients were randomly assigned (1:1) to receive either 200 mg of simethicone (Group A) or placebo (Group B). Two independent endoscopists reviewed the entire video recording from each examination to assess the quality of GMV. The primary outcome was the rate of adequate GMV, defined as the percentage of patients in each group with a video score scale < 7 based on gastric visualization of five gastric landmarks. Secondary outcomes included procedure duration, patient satisfaction, and side effects. Results A total of 110 consecutive outpatients were randomly assigned to one of the two study groups (11 were excluded for various reasons). For the primary endpoint, 32 patients (61.5 %) in group A achieved adequate GMV compared to one of 47 (2.1 %) in group B (odds ratio [95 % confidence interval]: 73.6 [9.4-576.6]; P < 0.001). Median procedure time did not differ between the groups ( P = 0.55), and no differences were detected in patient satisfaction ( P = 0.18) or side effects ( P = 0.58). No serious adverse events were documented. Conclusions Premedication with simethicone before upper gastrointestinal endoscopy significantly improves the quality of GMV without affecting the duration of the examination, patient satisfaction, and the rate of side effects.
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Affiliation(s)
- Leo Duez
- Department of Hepato-Gastroenterology, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium
| | - Paraskevas Gkolfakis
- Department of Hepato-Gastroenterology, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium
| | - Marine Bastide
- Department of Hepato-Gastroenterology, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium
| | - Clemence Vuckovic
- Department of Hepato-Gastroenterology, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium
| | - Carmen Musala
- Department of Hepato-Gastroenterology, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium
| | - Marc Van Gossum
- Department of Hepato-Gastroenterology, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium
| | - Alice Hoyois
- Department of Hepato-Gastroenterology, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium
| | - Jean-Pierre Mulkay
- Department of Hepato-Gastroenterology, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium
| | - Pierre Eisendrath
- Department of Hepato-Gastroenterology, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium
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Ferreira CN, Serrazina J, Marinho RT. Detection and Characterization of Early Gastric Cancer. Front Oncol 2022; 12:855216. [PMID: 35936695 PMCID: PMC9354496 DOI: 10.3389/fonc.2022.855216] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/14/2022] [Accepted: 06/10/2022] [Indexed: 11/30/2022] Open
Abstract
In this review, we would like to focus on risk stratification and quality indicators of diagnostic upper gastrointestinal endoscopy in the detection and characterization of early gastric cancer. Preparation of the upper gastrointestinal tract with mucolytic agents or simethicone is often overlooked in the west, and this inexpensive step prior to endoscopy can greatly improve the quality of imaging of the upper digestive tract. Risk stratification based on epidemiological features including family history, Helicobacter pylori infection status, and tobacco smoking is often overlooked but may be useful to identify a subgroup of patients at higher risk of developing gastric cancer. Quality indicators of diagnostic upper gastrointestinal endoscopy are now well defined and include: minimal inspection time of 3 min, adequate photographic documentation of upper gastrointestinal landmarks, utilization of advanced endoscopic imaging technology including narrow band imaging and blue laser imaging to detect intestinal metaplasia and characterize early gastric cancer; and standardized biopsy protocols allow for histological evaluation of gastric mucosa and detection of atrophic gastritis and intestinal metaplasia. Finally, endoscopic and histologic classifications such as the Kimura–Takemoto Classification of atrophic gastritis and the OLGA–OLGIM classifications may help stratify patients at a higher risk of developing early gastric cancer.
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Affiliation(s)
- Carlos Noronha Ferreira
- Serviço de Gastrenterologia e Hepatologia, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte, Lisbon, Portugal
- Clínica Universitária de Gastrenterologia, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal
- *Correspondence: Carlos Noronha Ferreira,
| | - Juliana Serrazina
- Serviço de Gastrenterologia e Hepatologia, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte, Lisbon, Portugal
| | - Rui Tato Marinho
- Serviço de Gastrenterologia e Hepatologia, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte, Lisbon, Portugal
- Clínica Universitária de Gastrenterologia, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal
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Namasivayam V, Koh CJ, Tsao S, Lee J, Ling KL, Khor C, Lim T, Li JW, Oo AM, Yip BCH, Hussain I, Chua TS, Toh BC, Ong HS, Wang LM, So JBY, Teh M, Yeoh KG, Ang TL. Academy of Medicine, Singapore clinical guideline on endoscopic surveillance and management of gastric premalignant lesions. ANNALS OF THE ACADEMY OF MEDICINE, SINGAPORE 2022; 51:417-435. [PMID: 35906941 DOI: 10.47102/annals-acadmedsg.2021433] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/15/2023]
Abstract
Gastric cancer (GC) has a good prognosis, if detected at an early stage. The intestinal subtype of GC follows a stepwise progression to carcinoma, which is treatable with early detection and intervention using high-quality endoscopy. Premalignant lesions and gastric epithelial polyps are commonly encountered in clinical practice. Surveillance of patients with premalignant gastric lesions may aid in early diagnosis of GC, and thus improve chances of survival. An expert professional workgroup was formed to summarise the current evidence and provide recommendations on the management of patients with gastric premalignant lesions in Singapore. Twenty-five recommendations were made to address screening and surveillance, strategies for detection and management of gastric premalignant lesions, management of gastric epithelial polyps, and pathological reporting of gastric premalignant lesions.
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Sun X, Xu Y, Zhang X, Ma C, Li A, Yu H, Zhang W, Zhang H, Yang T, Miao X, Zhang H, Liu Y, Lu Z. Simethicone administration improves gastric cleanness for esophagogastroduodenoscopy: a randomized clinical trial. Trials 2021; 22:555. [PMID: 34419109 PMCID: PMC8379843 DOI: 10.1186/s13063-021-05527-8] [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: 04/03/2020] [Accepted: 08/09/2021] [Indexed: 12/16/2022] Open
Abstract
Background Esophagogastroduodenoscopy is very useful in diagnosing and treating upper gastrointestinal mucosal disorders, but too much foam and water in stomach decrease its diagnostic efficiency. Simethicone administration can help remove excessive foam. Aims To determine the optimal simethicone administration strategies in a comparative randomized controlled clinical trial. Methods Adult outpatients with indications for esophagogastroduodenoscopy were enrolled and randomly divided into group 1 (simethicone solution intake 20–30 min before procedure, n = 110), group 2 (simethicone solution intake 31–60 min before procedure, n = 92), and group 3 (simethicone solution intake > 60 min before procedure). Primary and secondary outcomes were procedure time and the patients’ satisfaction after the examination. All symptoms like abdominal pain and distension were recorded. Results No statistically significant differences were found on the patients’ demographic and clinical features and mean examination time (all P values > 0.05). The distribution of patients with different endoscopic and pathological diagnosis was comparable among three groups, respectively (P = 0.607; P = 0.289). However, the proportion of patients with Gastric Cleanness Grade A was most in group 2 (n = 73, 79.3%), and patient proportion with Gastric Cleanness Grade C was most found in group 1 (n = 72, 65.5%), which was greatly different (P < 0.001). There was no statistically significant difference on the satisfaction scores [immediately 6 (3–8) vs. 6 (1–10) vs. 6 (1-9), P = 0.533; 2 h after 10 (8–10) vs. 10 (10–10) vs. 10 (8-10), P = 0.463]. Conclusion Simethicone solution intake 31–60 min before esophagogastroduodenoscopy can help obtain the best gastric cleanness, which is recommended in clinical practice (registered at ClinicalTrials.gov, NCT03776916 on December 13, 2018).
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Affiliation(s)
- Xiaotian Sun
- Gastrointestinal Endoscopy Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100071, China.,Department of Internal Medicine, Beijing South Medical District, Chinese PLA General Hospital, Beijing, 100161, China
| | - Yang Xu
- Gastrointestinal Endoscopy Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100071, China
| | - Xueting Zhang
- Gastrointestinal Endoscopy Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100071, China
| | - Cuiyun Ma
- Gastrointestinal Endoscopy Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100071, China
| | - Aitong Li
- Gastrointestinal Endoscopy Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100071, China
| | - Haiyan Yu
- Gastrointestinal Endoscopy Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100071, China
| | - Weihua Zhang
- Gastrointestinal Endoscopy Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100071, China
| | - Hanqing Zhang
- Gastrointestinal Endoscopy Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100071, China
| | - Teng Yang
- Gastrointestinal Endoscopy Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100071, China
| | - Xinfang Miao
- Clinic of Fuxing Road, Beijing South Medical District, Chinese PLA General Hospital, Beijing, 100161, China
| | - Huiming Zhang
- Clinic of Fuxing Road, Beijing South Medical District, Chinese PLA General Hospital, Beijing, 100161, China
| | - Yan Liu
- Gastrointestinal Endoscopy Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100071, China
| | - Zheng Lu
- Department of Hepatology, The Fifth Medical Center of Chinese PLA General Hospital, No. 100 Middle Road in Fourth West Ring, Beijing, 100039, China.
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Feasibility of Upper Gastrointestinal Examination in Home Care Setting with a Magnetically Assisted Capsule Endoscopy System: A Retrospective Study. Healthcare (Basel) 2021; 9:healthcare9050577. [PMID: 34068015 PMCID: PMC8152223 DOI: 10.3390/healthcare9050577] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/17/2021] [Revised: 05/10/2021] [Accepted: 05/10/2021] [Indexed: 12/12/2022] Open
Abstract
The magnetic assisted capsule endoscope (MACE) with a hand-held magnetic field navigator (MFN) for upper gastrointestinal examination achieved satisfactory results in a healthy volunteer study. We evaluated the feasibility of upper gastrointestinal examination in the home care setting with the MACE system. Home care patients with upper gastrointestinal symptoms that received an MACE exam were enrolled in the study. MACE procedure time; completeness of observation of important anatomical landmarks; endoscopic diagnosis; patient tolerance during the procedure; and patient data, including age, sex, comorbidities, symptoms, body weight, and height, were retrieved from hospital information system for data analysis. A total of 16 participants were enrolled with a mean age 74.3 ± 15.4 years (47 to 99 years). One patient failed to swallow the capsule and was excluded. The average procedure time was 23.7 ± 10.0 min (14.1 to 42.5 min) to complete each endoscopic exam for the remaining 15 patients. The overall maneuverability in the esophagus, stomach, and duodenum was 93.75%, 87.5%, and 75%, respectively. Overall completeness in the aforementioned regions was 93.75%, 81.25%, and 75%, respectively. No severe adverse events were noted. The results clearly demonstrate the promise of using this MACE system to perform endoscopic examination outside the hospital for patients confined to the community and home.
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Blanco Avellaneda CDJ, Barreto-Guevara MI, Walteros-Gordillo YL, Pinzón-Segura NA, Rivera-Velasco MDC, Bareño-Silva J. Cohortes de premedicación en endoscopia alta con Simeticona, N-acetylcisteina, Hedera helix y validación de escala visual. REVISTA COLOMBIANA DE GASTROENTEROLOGÍA 2021; 36:39-50. [DOI: 10.22516/25007440.582] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/06/2025]
Abstract
Los parámetros de calidad para endoscopia digestiva alta han introducido indicadores intraprocedimiento, dentro de los cuales la adecuada visibilidad de la mucosa, libre de saliva, moco o burbujas, puede aumentar la posibilidad de detección de lesiones en fase temprana. Sin embargo, el uso de mucolíticos y antiburbujas ha mostrado gran variabilidad de eficiencia según las soluciones, concentraciones, tiempos de exposición y escala de visibilidad aplicados.
Objetivos: determinar la efectividad de diferentes soluciones de premedicación para la limpieza de la mucosa digestiva; validar, mediante una prueba de concordancia interobservador, una nueva escala de adecuada visualización de la mucosa (TVMS) para el esófago, estómago y duodeno; y reportar eventos adversos o complicaciones relacionadas con las soluciones utilizadas y los procedimientos realizados.
Material y métodos: estudio de cohortes prospectivas comparativas. Se incluyeron 412 pacientes adultos, ASA I y ASA II, para endoscopia diagnóstica bajo sedación consciente, distribuidos en 6 cohortes similares, divididas en dos grupos: no premedicación, 2 cohortes C1 (ayuno de 6 a 8 horas)y C2 (agua 100 mL); premedicación, 4 cohortes C3 a C6 (C3: agua 100 m L + simeticona 1000 mg; C4: agua 100 mL + simeticona 200 mg + N-acetilcisteína 600 mg; C5: agua 100 mL + simeticona 200 mg + N-acetilcisteína 1000 mg; C6: agua 100 mL + simeticona 200 mg + Hedera helix 70 mg). Se ingirió la solución 15 a 30 minutos antes del paso por cricofaríngeo. Se realizó la prueba de Kappa para medir la concordancia interobservador de la escala TVMS.
Resultados: De 412 pacientes, 58 % fueron de sexo femenino; 23 % (136) fue de cohortes C1 y C2 y 67 % (276) fue de cohortes C3 a C6. El tiempo medio de exposición a cada solución fue de 24,4 minutos. El volumen de lavado para lograr una adecuada visualización fue significativamente diferente entre ambos grupos: en los pacientes con premedicación se utilizaron 75,6 mL, mientras que en los pacientes sin premedicación se utilizaron 124 mL (p = 0,000), con una calidad de TVMS excelente de 88,7 % frente al 41,4 %, respectivamente. La cohorte C4 (agua 100 mL + simeticona 200 mg + N-acetilcisteína 600 mg) mostró ser la más efectiva con una diferencia significativa (p = 0,001) frente a C1 (ayuno) y C2 (placebo con agua 100 mL), y también tuvo una eficiencia superior frente a C3, C5 y C6 en su orden. No se presentaron eventos adversos o complicaciones en relación con la endoscopia, la sedación y los productos usados en la premedicación.
Conclusiones: la solución más efectiva como premedicación para lograr una excelente visibilidad de la mucosa digestiva correspondió a la cohorte C4 (SIM 200 + NAC 600 + H2O 100 mL). La escala TVMS propuesta es una herramienta muy completa y fácil de aplicar por más de un observador. La premedicación ingerida, con antiburbuja, mucolítico y agua hasta 100 mL, entre 15 y 30 minutos previos a endoscopia, es segura en las condiciones descritas en este estudio.
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Does Premedication with Mucolytic Agents Improve Mucosal Visualization during Oesophagogastroduodenoscopy: A Systematic Review and Meta-Analysis. Surg Res Pract 2021; 2021:1570121. [PMID: 33553573 PMCID: PMC7846405 DOI: 10.1155/2021/1570121] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/19/2020] [Revised: 08/21/2020] [Accepted: 10/26/2020] [Indexed: 12/25/2022] Open
Abstract
Introduction Gastric Cancer (GC) is the fourth most common malignancy worldwide and the second leading cause of cancer-related mortality for both sexes. The gold standard for diagnosing GC is oesophagogastroduodenoscopy (OGD). Excess mucus on the gastric mucosa impairs the detection of early GC. Aim To synthesize available evidence of the effect of premedication with a mucolytic agent among adults undergoing elective nontherapeutic OGD, compared to placebo or other mucolytic agents, on mucosal visibility during OGD. Methods A systematic review was conducted. PubMed, EMBASE, CINAHL, Cochrane central register of controlled trials (CENTRAL), and Web of Science were searched for relevant studies. A random-effects meta-analysis was performed to determine the mean difference in total mucosal visibility score (TMVS) between the pooled mucolytic agents and control. Subgroup analyses were performed to determine the mean TMVS difference for simethicone versus control and the impact of different timings and doses of mucolytic premedication. Results 13 studies, involving 11,086 patients, including 6178 females (55.7%), with a mean age of 53.4 were identified and 6 of these were brought forward to meta-analysis. This revealed a mean difference of -2.69 (95% CI -3.5, -1.88) in total mucosal visibility scores (TMVS) between the pooled mucolytic agents and control. For simethicone, the mean difference was -2.68 (95% CI -4.94, -0.43). A simethicone dose of 133 mg was most effective with a mean difference of -4.22 (95% CI -5.11, -3.33). Assessing timing of administration across all mucolytic agents revealed a mean difference for the >20 minutes group of -3.68 (95% CI -4.77, -2.59). No adverse events were reported in any included trials. Conclusions Regular use of premedication with mucolytic agents prior to routine OGD is associated with improved TMVS with no reported adverse events.
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Manfredi G, Bertè R, Iiritano E, Alicante S, Londoni C, Brambilla G, Romeo S, Menozzi F, Griffanti P, Brandi G, Moreschi O, Pezzilli R, Zullo A, Buscarini E. Premedication with simethicone and N-acetylcysteine for improving mucosal visibility during upper gastrointestinal endoscopy in a Western population. Endosc Int Open 2021; 9:E190-E194. [PMID: 33532557 PMCID: PMC7834924 DOI: 10.1055/a-1315-0114] [Citation(s) in RCA: 13] [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: 08/06/2020] [Accepted: 10/05/2020] [Indexed: 02/06/2023] Open
Abstract
Background and study aim Pre-endoscopic use of a preparation with tensioactive and mucolytic agents improved gastric mucosa visualization in Eastern studies. Data on Western population are scanty. Patients and methods This prospective, endoscopist-blinded, randomized study enrolled patients who underwent esophagogastroduodenoscopy in a single center. Before endoscopy patients, were randomized to receive or not receive an oral preparation with simethicone and N-acetylcysteine in water. A pretested score (Crema Stomach Cleaning Score [CSCS]) for gastric mucosa cleaning evaluation was used. In detail, the stomach was divided into the antrum, body, and fundus and a score of 1 to 3 was assigned to each part (the higher the score, the better the preparation), and a total value ≤ 5 was considered as insufficient. Time between endoscope insertion and clean achievement (mouth to clean time) or the end of examination (mouth to mouth time) was recorded. Results A total of 197 patients were enrolled. The mean overall CSCS value and mucosal cleaning in all parts was better in treated patients than in controls. Prevalence total score ≤ 5 was significantly lower in patients treated before endoscopy. Need for water flush occurred less frequently in treated patients ( P < 0.0001). The mouth to clean time was lower in the treated than in the control group (2.3 ± 1.6 vs 3.8 ± 1.6 min; P < 0.001), whereas no significant difference in mouth to mouth time emerged. Conclusions Data from this study show that premedication with simethicone and N-acetylcysteine results in significantly better endoscopic visualization of gastric mucosa, and the proposed CSCS could be useful for standardizing this evaluation.
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Affiliation(s)
- Guido Manfredi
- Gastroenterology and Endoscopy Department, ASST Crema Maggiore Hospital, Crema, Italy
| | - Roberto Bertè
- Gastroenterology and Endoscopy Department, ASST Crema Maggiore Hospital, Crema, Italy,Gastroenterology and Endoscopy Department, ‘Ca’ Granda’ Hospital, Milan, Italy
| | - Elena Iiritano
- Gastroenterology and Endoscopy Department, ASST Crema Maggiore Hospital, Crema, Italy
| | - Saverio Alicante
- Gastroenterology and Endoscopy Department, ASST Crema Maggiore Hospital, Crema, Italy
| | - Claudio Londoni
- Gastroenterology and Endoscopy Department, ASST Crema Maggiore Hospital, Crema, Italy
| | - Giancarlo Brambilla
- Gastroenterology and Endoscopy Department, ASST Crema Maggiore Hospital, Crema, Italy
| | - Samanta Romeo
- Gastroenterology and Endoscopy Department, ASST Crema Maggiore Hospital, Crema, Italy
| | - Fernanda Menozzi
- Gastroenterology and Endoscopy Department, ASST Crema Maggiore Hospital, Crema, Italy
| | - Paola Griffanti
- Gastroenterology and Endoscopy Department, ASST Crema Maggiore Hospital, Crema, Italy
| | - Giovanna Brandi
- Gastroenterology and Endoscopy Department, ASST Crema Maggiore Hospital, Crema, Italy
| | - Oliva Moreschi
- Gastroenterology and Endoscopy Department, ASST Crema Maggiore Hospital, Crema, Italy
| | | | - Angelo Zullo
- Gastroenterology, ‘Nuovo Regina Margherita’ Hospital, Rome, Italy
| | - Elisabetta Buscarini
- Gastroenterology and Endoscopy Department, ASST Crema Maggiore Hospital, Crema, Italy
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Mahawongkajit P, Kanlerd A. A prospective randomized controlled trial comparing simethicone, N-acetylcysteine, sodium bicarbonate and peppermint for visualization in upper gastrointestinal endoscopy. Surg Endosc 2021; 35:303-308. [PMID: 32016519 DOI: 10.1007/s00464-020-07397-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/24/2019] [Accepted: 01/28/2020] [Indexed: 12/24/2022]
Abstract
OBJECTIVES Early cancer detection is crucial in improving the patients' quality of life and upper gastrointestinal endoscopy (EGD) plays a key role in this detection. Many clearing mechanisms may be applied to create good endoscopic visualizations for the upper gastrointestinal tract using mucolytic agents, antifoaming agents, proteolytic enzymes and neutralizers. The aim of this study is to compare the effects of simethicone, N-acetylcysteine (NAC), sodium bicarbonate and peppermint as pre-medications for visualization of esophagogastroduodenoscopy (EGD). METHODS This study was a single center prospective randomized controlled trial. The patients were randomly allocated to one of four treatment groups. Group A: water; Group B: water with simethicone; Group C: water with simethicone plus NAC 600 mg; Group D: water with simethicone, NAC, sodium bicarbonate and peppermint. RESULTS A total of 128 patients were enrolled and evaluated in this study. Total visibility score (TVS) of Groups A, B, C, and D were 13.4 ± 1.86, 10.5 ± 1.45, 7.15 ± 0.98 and 6.4 ± 1.43, respectively. Group D showed lower TVS than other groups. The procedural durations of Groups C and D were significantly shorter than Group A. The volume of solution for mucosal cleansing of Groups C and D was significantly lower than Groups A and B. CONCLUSIONS The application of simethicone plus NAC is safe, improves endoscopic visualization and requires a minimal amount of mucosal cleansing solution. The addition of sodium bicarbonate and peppermint further improved visualization for the upper and lower gastric body. Thai Clinical Trials Registry (TCTR) with a reference number; TCTR20190501002.
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Affiliation(s)
- Prasit Mahawongkajit
- Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), 99/209 Moo 18, Paholyothin Road, Amphur Klongluang, Pathumthani, 12120, Thailand.
| | - Amonpon Kanlerd
- Department of Surgery, Faculty of Medicine, Thammasat University (Rangsit Campus), 99/209 Moo 18, Paholyothin Road, Amphur Klongluang, Pathumthani, 12120, Thailand
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Peshevska-Sekulovska M, Velikova TV, Peruhova M. Artificial intelligence assisted endocytoscopy: A novel eye in endoscopy. Artif Intell Gastrointest Endosc 2020; 1:44-52. [DOI: 10.37126/aige.v1.i3.44] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/01/2020] [Revised: 11/29/2020] [Accepted: 12/06/2020] [Indexed: 02/06/2023] Open
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Teh JL, Shabbir A, Yuen S, So JBY. Recent advances in diagnostic upper endoscopy. World J Gastroenterol 2020; 26:433-447. [PMID: 32063692 PMCID: PMC7002908 DOI: 10.3748/wjg.v26.i4.433] [Citation(s) in RCA: 34] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/13/2019] [Revised: 01/10/2020] [Accepted: 01/14/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Esophageo-gastro-duodenoscopy (EGD) is an important procedure used for detection and diagnosis of esophago-gastric lesions. There exists no consensus on the technique of examination.
AIM To identify recent advances in diagnostic EGDs to improve diagnostic yield.
METHODS We queried the PubMed database for relevant articles published between January 2001 and August 2019 as well as hand searched references from recently published endoscopy guidelines. Keywords used included free text and MeSH terms addressing quality indicators and technological innovations in EGDs. Factors affecting diagnostic yield and EGD quality were identified and divided into the follow segments: Pre endoscopy preparation, sedation, examination schema, examination time, routine biopsy, image enhanced endoscopy and future developments.
RESULTS We identified 120 relevant abstracts of which we utilized 67 of these studies in our review. Adequate pre-endoscopy preparation with simethicone and pronase increases gastric visibility. Proper sedation, especially with propofol, increases patient satisfaction after procedure and may improve detection of superficial gastrointestinal lesions. There is a movement towards mandatory picture documentation during EGD as well as dedicating sufficient time for examination improves diagnostic yield. The use of image enhanced endoscopy and magnifying endoscopy improves detection of squamous cell carcinoma and gastric neoplasm. The magnifying endoscopy simple diagnostic algorithm is useful for diagnosis of early gastric cancer.
CONCLUSION There is a steady momentum in the past decade towards improving diagnostic yield, quality and reporting in EGDs. Other interesting innovations, such as Raman spectroscopy, endocytoscopy and artificial intelligence may have widespread endoscopic applications in the near future.
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Affiliation(s)
- Jun-Liang Teh
- Department of Surgery, National University Hospital System, Singapore 119228, Singapore
- Department of Surgery, Jurong Health Campus, National University Health System, Singapore 609606, Singapore
| | - Asim Shabbir
- Department of Surgery, National University Hospital System, Singapore 119228, Singapore
| | - Soon Yuen
- Department of Surgery, National University Hospital System, Singapore 119228, Singapore
- Department of Surgery, Jurong Health Campus, National University Health System, Singapore 609606, Singapore
| | - Jimmy Bok-Yan So
- Department of Surgery, National University Hospital System, Singapore 119228, Singapore
- Department of Surgery, National University of Singapore, Singapore 119074, Singapore
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Zuberi BF, Shaikh MA, Ali FS, Rasheed T, Nawaz Z. Effect of pre-endoscopy intake of simethicone solution on endoscopic mucosal visibility: A single blinded, placebo control, randomized trial. Pak J Med Sci 2020; 36:172-176. [PMID: 32063954 PMCID: PMC6994877 DOI: 10.12669/pjms.36.2.1241] [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: 06/17/2019] [Revised: 07/04/2019] [Accepted: 10/26/2019] [Indexed: 11/15/2022] Open
Abstract
OBJECTIVE To determine effect of pre-endoscopy intake of simethicone solution on endoscopic mucosal visibility. METHODOLOGY A randomized, single blinded placebo control trial was done in patients undergoing oesophago-gastro-duodenoscopy for any indication at DOTs Endoscopy Suite, CHK during the period of April to June 2019. Informed consent was taken. Patients were randomly allocated in two groups. Group-A received placebo while Group-B received Simethicone. Evaluation of mucosal visibility was assessed at 4 sites (oesophagus, fundus, antrum & duodenum) by previously validated scoring. Mean of visibility scores were compared in two groups. RESULTS Two hundred and forty-eight patients were inducted and randomly allocate to two groups of 124 each. Mean of total sum of scores in Group-A was 8.14 ±2.44 and that of Group-B was 5.80 ±1.75 (p<0.001). Adequate visibility in Group-A was seen in 41.1% and that in Group-B was 78.2% (p<0.001). CONCLUSION Use of Simethicone significantly improves mucosal visibility during OGD.
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Affiliation(s)
- Bader Faiyaz Zuberi
- Bader Faiyaz Zuberi, Department of Medicine, Dow University of Health Sciences, Karachi, Pakistan
| | - Majid Ahmed Shaikh
- Majid Ahmed Shaikh, Department of Medicine, Dow University of Health Sciences, Karachi, Pakistan
| | - Faiza Sadaqat Ali
- Faiza Sadaqat Ali, Department of Medicine, Dow University of Health Sciences, Karachi, Pakistan
| | - Tazeen Rasheed
- Tazeen Rasheed, Department of Medicine, Dow University of Health Sciences, Karachi, Pakistan
| | - Zunaira Nawaz
- Zunaira Nawaz Department of Medicine, Dow University of Health Sciences, Karachi, Pakistan
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Li Y, Du F, Fu D. The effect of using simethicone with or without N-acetylcysteine before gastroscopy: A meta-analysis and systemic review. Saudi J Gastroenterol 2019; 25:218-228. [PMID: 31044749 PMCID: PMC6714471 DOI: 10.4103/sjg.sjg_538_18] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/29/2022] Open
Abstract
BACKGROUND/AIM To assess the efficacy and safety of simethicone with or without N-acetylcysteine (NAC) as premedications before gastroscopy. MATERIALS AND METHODS We searched EMBASE, PubMed, Cochrane library and Web of Science database for randomized clinical controlled trials regarding simethicone ± NAC as oral drinking agents before gastroscopy. Statistical software RevMan5.3 was used for statistical analysis. RESULTS Ten randomized clinical trials that fulfilled the inclusion criteria were further pooled into a meta-analysis, which included 5,750 patients. The rate of positive findings in simethicone plus NAC group was higher than that in water group (risk ratio [RR] =1.31, 95%CI: 1.12-1.53, P = 0.0006) with high level of evidence. There was no significant difference on the rate of positive findings when comparing simethicone with simethicone plus NAC (RR = 1.02, 95%CI: 0.90-1.16, P = 0.71) and with water (RR = 1.13, 95%CI: 0.82-1.55, P = 0.46), respectively. Simethicone plus NAC showed better total mucosal visibility score than simethicone alone (MD = -0.14 (-0.25, -0.03), P = 0.01) without obvious heterogeneity. Both simethicone plus NAC and simethicone alone offer more benefit than water. The procedure time in simethicone group was shorter than that in water group (MD = -1.23 (-1.51, -0.96), P < 0.00001). Regarding adverse events, there was no significant difference in simethicone and water group (RR = 0.45, 95%CI: 0.2-1.0, P = 0.05, I2 = 0%). CONCLUSIONS As premedication of gastroscopy, simethicone plus NAC offers more benefit on positive findings and total mucosal visibility score.
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Affiliation(s)
- Yuanfa Li
- Department of Gastroenterology, Xiantao First People's Hospital, China,Address for correspondence: Dr. Yuanfa Li, No. 29, Mianzhoudadao Road, Sha Zui District Xiantao City, Hubei Province, China. E-mail:
| | - Fangjuan Du
- Department of Gastroenterology, Liaocheng Second People's Hospital, China
| | - Dou Fu
- Internal Medicine, Xiantao First People's Hospital, China
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Sajid MS, Rehman S, Chedgy F, Singh KK. Improving the mucosal visualization at gastroscopy: a systematic review and meta-analysis of randomized, controlled trials reporting the role of Simethicone ± N-acetylcysteine. Transl Gastroenterol Hepatol 2018; 3:29. [PMID: 29971260 DOI: 10.21037/tgh.2018.05.02] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/29/2018] [Accepted: 05/03/2018] [Indexed: 01/01/2023] Open
Abstract
Background The objective of this article is to study the role of Simethicone ± N-acetylcysteine in improving the mucosal visualization during oesophago-gastro-duodenoscopy (OGD). Methods The data retrieved from the published randomized controlled trials (RCTs) reporting the role of Simethicone ± N-acetylcysteine during OGD was analysed using the principles of meta-analysis. The summated outcome of continuous variables was expressed as standardized mean difference (SMD) and dichotomous data was presented in odds ratio (OR). Results Three RCTs on 654 patients reported OGD with and without pre-procedure oral administration of Simethicone ± N-acetylcysteine evaluating visibility as good or excellent in number during the procedure. In the random effects model analysis using the statistical software Review Manager 5.3, the use of Simethicone ± N-acetylcysteine was associated with improved (OR, 0.43; 95% CI, 0.28, 0.68; z=3.65; P=0.0003) mucosal visibility. Four RCTs on 364 patients reported OGD with and without pre-procedure oral administration of Simethicone ± N-acetylcysteine evaluating visibility score in study group. In the random effects model analysis using the statistical software Review Manager 5.3, the use of Simethicone ± N-acetylcysteine was associated with improved (SMD, -1.66; 95% CI, -1.93, -1.40; z=12.25; P=0.00001) mucosal visibility score compared to no-Simethicone group. Conclusions The findings of current study on 1,099 patients successfully demonstrate that the pre-procedure oral administration of Simethicone ± N-acetylcysteine improves mucosal visualization and mucosal visualization score during OGD.
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Affiliation(s)
- Muhammad Shafique Sajid
- Department of General and Colorectal Surgery, Brighton & Sussex University Hospitals NHS Trust, The Royal Sussex County Hospital, Brighton, UK
| | - Saad Rehman
- Department of General and Colorectal Surgery, Brighton & Sussex University Hospitals NHS Trust, The Royal Sussex County Hospital, Brighton, UK
| | - Fergus Chedgy
- Department of Gastroenterology & Hepatology, Brighton & Sussex University Hospitals NHS Trust, The Royal Sussex County Hospital, Brighton, UK
| | - Krishna K Singh
- Department of General and Upper GI Surgery, Brighton & Sussex University Hospitals NHS Trust, The Royal Sussex County Hospital, Brighton, UK
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Effect of premedication on lesion detection rate and visualization of the mucosa during upper gastrointestinal endoscopy: a multicenter large sample randomized controlled double-blind study. Surg Endosc 2018; 32:3548-3556. [PMID: 29572630 PMCID: PMC6061056 DOI: 10.1007/s00464-018-6077-4] [Citation(s) in RCA: 25] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/21/2017] [Accepted: 01/28/2018] [Indexed: 02/06/2023]
Abstract
BACKGROUND Premedication in upper gastrointestinal endoscopy for higher lesions detection rate has not been well studied so far. This study aimed to confirm whether premedication could improve the detection rate of early cancer or precancerous lesions and mucosal visibility. METHOD From July 2015 to December 2015, 7200 participants from 6 centers were screened by endoscopy with one of the 4 following premedications randomly: (1) water (group D); (2) pronase (group A); (3) simethicone (group B); (4) pronase and simethicone (group C). Early cancer and precancerous lesions detection rates were taken as the primary endpoints, and mucosal visibility was taken as the secondary endpoint. They were compared among four groups to determine different premedication effects in terms of different anatomical sites. Trial was registered at Chinese Clinical Trial Registry; the registration number is ChiCTR-IOR-17010985. RESULTS The upper gastrointestinal overall precancerous lesion detection rates among four groups were 8.7, 8.4, 10.0, and 10.3%, the overall early cancer detection rates were 1.3, 1.4%, 1.5, and 1.6%, both without significant difference (p = 0.138 and 0.878). However, the visibility score distributions between control group (D) and premedication groups (A, B, and C) were all statistically significant, with all anatomical sites p values < 0.001. Subgroup analyses, from 2 centers without screening before, also showed significant difference in esophageal (3.9, 3.3, 4.5, and 8.4% with p = 0.004) and overall (7.0, 5.5, 7.3, and 12.0% with p = 0.004) precancerous lesion detection rate. CONCLUSIONS Premedication with pronase and simethicone may not increase lesion detection rates but could significantly increase the upper gastrointestinal mucosal visibility.
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