1
|
Rosen H, Sebesta C, Sebesta MC, Sebesta C. Therapeutic Management of Gastroesophageal Reflux Disease (GERD)-Is There Something Between PPI and Fundoplication? An Overview. J Clin Med 2025; 14:362. [PMID: 39860368 PMCID: PMC11766380 DOI: 10.3390/jcm14020362] [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: 12/10/2024] [Revised: 12/30/2024] [Accepted: 01/07/2025] [Indexed: 01/27/2025] Open
Abstract
Gastroesophageal reflux disease (GERD) affects millions globally, with traditional treatments like proton pump inhibitors (PPIs) and surgical fundoplication presenting challenges such as long-term medication dependency and disturbing long term side effects following surgery. This review explores emerging, alternative therapies that offer less invasive, personalized alternatives for GERD management. Endoscopic approaches, including Stretta therapy, transoral incisionless fundoplication (TIF), and endoscopic full-thickness plication (EFTP), demonstrate promising but also controversial outcomes in symptom relief and reduced acid exposure. Laparoscopic electrical stimulation therapy (EndoStim®) and the LINX® magnetic sphincter augmentation system address LES dysfunction, while endoscopic anti-reflux mucosectomy and/or ablation techniques aim to construct a sufficient acid barrier. The RefluxStop™ device offers structural solutions to GERD pathophysiology with intriguing results in initial studies. Despite promising results, further research is required to establish long-term efficacy, safety, and optimal patient selection criteria for these novel interventions. This review underscores the importance of integrating emerging therapies into a tailored, multidisciplinary approach to GERD treatment.
Collapse
Affiliation(s)
- Harald Rosen
- Centre of Surgery, Sigmund Freud Private University, A-1020 Vienna, Austria;
| | - Christian Sebesta
- Department of Gastroenterology, Clinic Donaustadt, SMZ-Ost, Langobardenstrasse 122, A-1220 Vienna, Austria
| | - Marie Christine Sebesta
- Department of Gastroenterology, Clinic Donaustadt, SMZ-Ost, Langobardenstrasse 122, A-1220 Vienna, Austria
| | - Christian Sebesta
- Department of Gastroenterology, Clinic Donaustadt, SMZ-Ost, Langobardenstrasse 122, A-1220 Vienna, Austria
- Department of Internal Medicine, Clinic Donaustadt, SMZ-Ost, Langobardenstrasse 122, A-1220 Vienna, Austria
| |
Collapse
|
2
|
Shahzil M, Chaudhary AJ, Qureshi AA, Hasan F, Faisal MS, Sohail A, Khaqan MA, Jamali T, Khan MZ, Alsheik E, Zuchelli T. Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Randomized Sham Controlled Trials. JGH Open 2024; 8:e70056. [PMID: 39605898 PMCID: PMC11599161 DOI: 10.1002/jgh3.70056] [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: 06/13/2024] [Revised: 09/13/2024] [Accepted: 11/11/2024] [Indexed: 11/29/2024]
Abstract
Introduction Gastroesophageal reflux disease (GERD) affects approximately 20% of adults in the United States. Proton pump inhibitors are the first-line treatment but are associated with long-term side effects. Endoscopic full-thickness plication (EFTP) is a minimally invasive alternative that improves the valvular mechanism of the gastroesophageal junction. This meta-analysis compared EFTP to a sham procedure for the treatment of refractory GERD. Materials and Methods This meta-analysis followed the Cochrane guidelines and PRISMA standards and was registered with PROSPERO (CRD42023485506). We searched MEDLINE, Embase, SCOPUS, and Cochrane Library through December 2023. Inclusion criteria targeted Randomized controlled trials comparing EFTP with sham procedures for GERD were included. Statistical analyses utilized RevMan with a random-effects model, and the results were considered significant at p < 0.05. Results Of the 2144 screened studies, three RCTs with 272 patients with GERD were included: 136 patients underwent EFTP and 136 underwent sham procedures. Primary outcomes showed a significant reduction in PPI usage (RR 0.51; 95% CI 0.35-0.73; p < 0.01) and more than 50% improvement in GERD-HRQL scores at 3 months (RR 15.81; 95% CI 1.40-178.71; p = 0.03). No significant difference was found in the DeMeester scores (MD: 12.57; 95% CI -35.12 to 9.98; p = 0.27). Secondary outcomes showed no significant difference in time with esophageal pH < 4, but a significant reduction in total reflux episodes. Conclusions EFTP significantly reduced PPI usage, improved GERD-HRQL scores, and decreased total reflux episodes compared with sham procedures, highlighting its potential as a minimally invasive treatment. Further research is needed to compare EFTP with other minimally invasive techniques to determine the most effective treatment option.
Collapse
Affiliation(s)
- Muhammad Shahzil
- Department of Internal MedicineWeiss Memorial Hospital LLCChicagoIllinoisUSA
| | | | | | - Fariha Hasan
- Department of Internal MedicineCooper University HospitalCamdenNew JerseyUSA
| | | | - Abdullah Sohail
- Department of Internal MedicineUniversity of Iowa Hospitals and ClinicsIowa CityIowaUSA
| | - Muhammad Ali Khaqan
- Department of Internal MedicineJohn H. Stroger, Jr. Hospital of Cook CountyChicagoIllinoisUSA
| | - Taher Jamali
- Department of GastroenterologyHenry Ford HospitalDetroitMichiganUSA
| | | | - Eva Alsheik
- Department of GastroenterologyHenry Ford HospitalDetroitMichiganUSA
| | - Tobias Zuchelli
- Department of GastroenterologyHenry Ford HospitalDetroitMichiganUSA
| |
Collapse
|
3
|
Bortolotti M. Problems with repairing gut sphincters malfunctions. World J Gastrointest Surg 2024; 16:2396-2408. [PMID: 39220086 PMCID: PMC11362937 DOI: 10.4240/wjgs.v16.i8.2396] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2024] [Revised: 06/24/2024] [Accepted: 07/15/2024] [Indexed: 08/16/2024] Open
Abstract
Correcting a gut sphincter malfunction is a difficult problem. Because each sphincter has two opposite functions, that of closure and opening, repairing one there is a risk of damaging the other. Indeed, widening a narrow sphincter, such as lower esophageal sphincter (LES) and anal sphincter, may cause gastroesophageal reflux and fecal incontinence, respectively, whereas narrowing a wide sphincter, may cause a difficult transit. All the corrective treatments for difficult or retrograde transit concerning LES and anal sphincter with their unwanted consequences have been analyzed and discussed. To overcome the drawbacks of sphincter surgical repairs, researchers have devised devices capable of closing and opening the gut lumen, named artificial sphincters (ASs). Their function is based on various mechanisms, e.g., hydraulic, magnetic, mechanical etc, operating through many complicated components, such as plastic cuffs, balloons, micropumps, micromotors, connecting tubes and wires, electromechanical clamps, rechargeable batteries, magnetic devices, elastic bands, etc. Unfortunately, these structures may facilitate the onset of infections and induce a local fibrotic reaction, which may cause device malfunctioning, whereas the compression of the gut wall to occlude the lumen may give rise to ischemia with erosions and other lesions. Some ASs are already being used in clinical practice, despite their considerable limits, while others are still at the research stage. In view of the adverse events of the ASs mentioned above, we considered applying bioengineering methods to analyze and resolve biomechanical and biological interaction problems with the aim to conceive and build efficient and safe biomimetic ASs.
Collapse
Affiliation(s)
- Mauro Bortolotti
- Department of Internal Medicine and Gastroenterology, S Orsola-Malpighi Polyclinic, University of Bologna, Bologna 40138, Italy
| |
Collapse
|
4
|
Maydeo A, Patil G, Kamat N, Dalal A, Vadgaonkar A, Parekh S, Daftary R, Vora S. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux after peroral endoscopic myotomy: a randomized sham-controlled study. Endoscopy 2023; 55:689-698. [PMID: 36944359 PMCID: PMC10374353 DOI: 10.1055/a-2040-4042] [Citation(s) in RCA: 13] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2022] [Accepted: 02/01/2023] [Indexed: 03/23/2023]
Abstract
BACKGROUND : Endoscopic full-thickness plication (EFTP) has shown promising results in gastroesophageal reflux disease (GERD), but its efficacy in GERD after peroral endoscopic myotomy (POEM) is unclear. METHODS : In a prospective, randomized trial of post-POEM patients dependent on proton pump inhibitors (PPIs) for documented GERD, patients underwent EFTP (plication to remodel the gastroesophageal flap valve) or an endoscopic sham procedure (positioning of the EFTP device, but no stapling). The primary end point was improvement in acid exposure time (AET) < 6 % (3 months). Secondary end points included improvement in esophagitis (3 months), GERD Questionnaire (GERDQ) score (3 and 6 months), and PPI usage (6 months). RESULTS : 60 patients were randomized (30 in each group). At 3 months, a significantly higher proportion of patients achieved improvement in AET < 6 % in the EFTP group compared with the sham group (69.0 % [95 %CI 52.1-85.8] vs. 10.3 % [95 %CI 0-21.4], respectively). EFTP was statistically superior to sham (within-group analysis) in improving esophageal AET, DeMeester Score, and all reflux episodes (P < 0.001). A nonsignificant improvement in esophagitis was noted in the EFTP group (P = 0.14). Median GERDQ scores (3 months) were significantly better (P < 0.001) in the EFTP group, and the same trend continued at 6 months. A higher proportion of patients in the sham group continued to use PPIs (72.4 % [95 %CI 56.1-88.7] vs. 27.6 % [95 %CI 11.3-43.8]). There were no major adverse events in either group. CONCLUSION : EFTP improved post-POEM GERD symptoms, 24-hour pH impedance findings with normalization in one-third, and reduced PPI usage at 6 months.
Collapse
Affiliation(s)
- Amit Maydeo
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Gaurav Patil
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Nagesh Kamat
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Ankit Dalal
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Amol Vadgaonkar
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Sanil Parekh
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Rajen Daftary
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Sehajad Vora
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| |
Collapse
|
5
|
Hajjar A, Verhoeff K, Jogiat U, Mocanu V, Birch DW, Switzer NJ, Wong C, Karmali S. Endoscopic plication compared to laparoscopic fundoplication in the treatment of gastroesophageal reflux disease: a systematic review and meta-analysis. Surg Endosc 2023:10.1007/s00464-023-10202-x. [PMID: 37407715 DOI: 10.1007/s00464-023-10202-x] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2023] [Accepted: 06/11/2023] [Indexed: 07/07/2023]
Abstract
INTRODUCTION Endoscopic plication offers an alternative to surgical fundoplication for treatment of gastroesophageal reflux disease (GERD). This systematic review and meta-analysis evaluate outcomes following endoscopic plication compared to laparoscopic fundoplication. METHODS AND PROCEDURES Systematic search of MEDLINE, Embase, Scopus, and Web of Science was conducted in September 2022. Study followed PRISMA guidelines. Studies comparing endoscopic plication to laparoscopic fundoplication with n > 5 were included. Primary outcome was PPI cessation, with secondary outcomes including complications, procedure duration, length of stay, change in lower esophageal sphincter (LES) tone, and DeMeester score. RESULTS We reviewed 1544 studies, with five included comparing 105 (46.1%) patients receiving endoscopic plication (ENDO) to 123 (53.9%) undergoing laparoscopic fundoplication (LAP). Average patient age was 47.6 years, with those undergoing plication being younger (46.4 ENDO vs 48.5 LAP). BMI (26.6 kg/m2 ENDO vs 26.2 kg/m2 LAP), and proportion of females (42.9% ENDO vs 37.4% LAP) were similar. Patients undergoing laparoscopic procedures had worse baseline LES pressure (12.8 mmHg ENDO vs 9.0 mmHg LAP) and lower preoperative DeMeester scores (34.6 ENDO vs. 34.1 LAP). The primary outcome demonstrated that 89.2% of patients undergoing laparoscopic fundoplication discontinued PPI compared to 69.4% for those receiving plication. Meta-analysis revealed that plication had significantly reduced odds of PPI discontinuation (OR 0.27, studies = 3, 95% CI 0.12 to 0.64, P = 0.003, I2 = 0%). Secondary outcomes demonstrated that odds of complications (OR 1.46, studies = 4, 95% CI 0.34 to 6.32, P = 0.62, I2 = 0%), length of stay (MD - 1.37, studies = 3, 95% CI - 3.48 to 0.73, P = 0.20, I2 = 94%), and procedure durations were similar (MD 0.78, studies = 3, 95% CI - 39.70 to 41.26, P = 0.97, I2 = 98%). CONCLUSIONS This is the first meta-analysis comparing endoscopic plication to laparoscopic fundoplication. Results demonstrate greater likelihood of PPI discontinuation with laparoscopic fundoplication with similar post-procedural risk.
Collapse
Affiliation(s)
- Alexander Hajjar
- Department of Surgery, University of Alberta Hospital, University of Alberta, Edmonton, AB, Canada
| | - Kevin Verhoeff
- Department of Surgery, University of Alberta Hospital, University of Alberta, Edmonton, AB, Canada.
| | - Uzair Jogiat
- Department of Surgery, University of Alberta Hospital, University of Alberta, Edmonton, AB, Canada
| | - Valentin Mocanu
- Department of Surgery, University of Alberta Hospital, University of Alberta, Edmonton, AB, Canada
| | - Daniel W Birch
- Department of Surgery, University of Alberta Hospital, University of Alberta, Edmonton, AB, Canada
| | - Noah J Switzer
- Centre for Advancement of Surgical Education and Simulation (CASES), Royal Alexandra Hospital, Edmonton, AB, Canada
| | - Clarence Wong
- Division of Gastroenterology, University of Alberta, Edmonton, AB, Canada
| | - Shahzeer Karmali
- Centre for Advancement of Surgical Education and Simulation (CASES), Royal Alexandra Hospital, Edmonton, AB, Canada
| |
Collapse
|
6
|
Meining A, Hann A, Fuchs KH. Innovations in GI-endoscopy. Arab J Gastroenterol 2022; 23:139-143. [PMID: 35738990 DOI: 10.1016/j.ajg.2022.06.003] [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: 11/29/2022]
Abstract
Gastrointestinal endoscopy covers both diagnosis and therapy. Due to its diagnostic accuracy and minimal invasiveness, several innovations have been made within the last years including artificial intelligence and endoscopic tumor resection. The present review highlights some of these innovation. In addition, a special focus is set on the experience made by our own research group trying to combine the expertise of endoscopists/ physicians as well as engineers and computer scientists.
Collapse
Affiliation(s)
- Alexander Meining
- Interventional and Experimental Endoscopy (InExEn), Internal Medicine II, University Hospital Würzburg, Würzburg, Germany.
| | - Alexander Hann
- Interventional and Experimental Endoscopy (InExEn), Internal Medicine II, University Hospital Würzburg, Würzburg, Germany
| | - Karl Hermann Fuchs
- Interventional and Experimental Endoscopy (InExEn), Internal Medicine II, University Hospital Würzburg, Würzburg, Germany
| |
Collapse
|
7
|
Kalapala R, Singla N, Reddy DN. Endoscopic management of gastroesophageal reflux disease: Panacea for proton pump inhibitors dependent/refractory patients. Dig Endosc 2022; 34:687-699. [PMID: 34651353 DOI: 10.1111/den.14169] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/29/2021] [Revised: 10/06/2021] [Accepted: 10/12/2021] [Indexed: 02/08/2023]
Abstract
Endoscopic therapies in proton pump inhibitors (PPI) dependent/refractory gastroesophageal reflux disease (GERD) are increasingly indicated in patients who are not suitable or willing for chronic medical therapy and surgical fundoplication. Currently available endoluminal anti-reflux procedures include radiofrequency therapy (Stretta), suturing/plication and mucosal ablation/resection techniques at the gastroesophageal junction. Meticulous work up and patient selection results in a favorable outcome with these endoscopic therapies, especially the quality of life and partially the PPI independence. Stretta can be considered in patients with PPI refractory GERD and might have a role in patients with reflux hypersensitivity and functional heartburn. Endoscopic fundoplication using the Esophyx device and the GERD-X device have strong evidence (multiple randomized controlled trials) in patients with small hiatus hernia and high volume reflux episodes. Mucosal resection/ablation techniques like anti-reflux mucosectomy and anti-reflux mucosal ablation have shown promising results but need long term follow-up studies to prove their efficacy. The subset of PPI dependent GERD population will benefit from endoscopic therapies and the future of endoscopic management of GERD looks promising.
Collapse
Affiliation(s)
| | - Neeraj Singla
- Asian Institute of Gastroenterology, Hyderabad, India
| | | |
Collapse
|
8
|
Patel D, Fass R, Vaezi M. Untangling Nonerosive Reflux Disease From Functional Heartburn. Clin Gastroenterol Hepatol 2021; 19:1314-1326. [PMID: 32246998 DOI: 10.1016/j.cgh.2020.03.057] [Citation(s) in RCA: 22] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/13/2019] [Revised: 03/23/2020] [Accepted: 03/23/2020] [Indexed: 02/07/2023]
Abstract
Heartburn is a common symptom in clinical practice, but as many as 70% of patients have normal findings from upper endoscopy. Most of these patients have nonerosive reflux disease (NERD) or functional esophageal disorders. NERD is the most common phenotype of gastroesophageal reflux disease, and functional heartburn is the most common cause for refractory heartburn. In patients with NERD, symptoms arise from gastroesophageal reflux and esophageal hypersensitivity, whereas in patients with functional heartburn, symptoms result from esophageal hypersensitivity. A diagnosis of NERD requires endoscopy and reflux testing, whereas a diagnosis of functional heartburn also requires esophageal manometry. NERD is treated most commonly with medical, endoscopic, and surgical antireflux approaches, whereas functional heartburn as well as NERD can be treated with neuromodulators, psychological intervention, and complementary medicine options.
Collapse
Affiliation(s)
- Dhyanesh Patel
- Division of Gastroenterology, Hepatology, and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee.
| | - Ronnie Fass
- Division of Gastroenterology and Hepatology, MetroHealth System, Case Western Reserve University, Cleveland, Ohio
| | - Michael Vaezi
- Division of Gastroenterology, Hepatology, and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee
| |
Collapse
|
9
|
Tyselskyi V, Poylin V, Tkachuk O, Kebkalo A. Antireflux surgery is required after endoscopic treatment for Barrett's esophagus. POLISH JOURNAL OF SURGERY 2021; 93:1-5. [PMID: 34552027 DOI: 10.5604/01.3001.0014.8863] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
Abstract
<b>Introduction:</b> Barrett's esophagus is an acquired condition that develops as a result of transformation of normal stratified squamous epithelium in the lower part of the esophagus into columnar epithelium. Barrett's esophagus is considered to be a complication of gastroesophageal reflux disease (GERD). Various endoscopic techniques have been shown to be successful in the treatment of this condition. However, long-term success in preventing further esophageal dysplasia is not clear. Biological welding consists in the application of controlled high-frequency current on living tissues and has been used to stop gastrointestinal bleeding, similarly to the APC technique which involves ablation of small intestinal metaplasia of the esophageal mucosa.<br/> <b>Aim:</b> The goal of this study was to evaluate the effectiveness of endoscopic techniques in the treatment of Barrett's esophagus and verify the need for a subsequent surgical intervention in patients with GERD complicated by Barrett's esophagus. <br/><b> Material and methods: </b> Patients with Barrett's esophagus C1-3M2-4 (Prague classification from 2004) and high dysplasia without nodules, as well as patients with confirmed GERD without hiatal hernia, were included in this study. Endoscopic treatment was performed with the use of argonoplasmic coagulation (APC) and high-frequency welding of living tissues (HFW). After the examination the patients were re-examined. Patients with recurrence of metaplasia and high DeMeester score (˃ 100) underwent antireflux surgery - crurography and Nissen fundoplication with creation of a soft and short cuff.<br/><b>Results:</b> A total of 89 patients were included in the study, 81 of whom were reexamined after ablation of Barrett's esophagus.In 12 patients, a recurrence of intestinal metaplasia resembling the small intestine was identified. Implementation of two-stage treatment was required for 9 patients - it involved a second procedure of ablation of the esophagus, followed by antireflux surgery. Surgical treatment was refused by 3 patients, who underwent only the second ablation procedure. All patients received drug therapy, consisting of prokinetics and proton pump inhibitors. Esophageal pH monitoring was repeated 3 months after surgery, showing normalization of the DeMeester score. As a result, the patients experienced no complaints such as heartburn, chest pain or dysphagia, which significantly improved their quality of life. Esophagogastroduodenoscopy and biopsy of the mucous membrane of the lower third of the esophagus were performed in accordance with the Seattle Protocol. After examining histological specimens, no regions of metaplasia were identified. <br/><b>Conclusion:</b> Antireflux surgery is required as a part of the treatment for Barrett's esophagus, which prevents further dysplasia and development of esophageal cancer.<br/>.
Collapse
Affiliation(s)
- Volodymyr Tyselskyi
- Department of Surgery and Proctology and Gastrointestinal Surgery, Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine
| | - Vitaliy Poylin
- Surgery Feinberg School of Medicine, Gastrointestinal Surgery Northwestern Medical Group, Chicago, USA
| | - Olga Tkachuk
- Department of Surgery and Proctology and Gastrointestinal Surgery, Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine
| | - Andrey Kebkalo
- Department of Surgery and Proctology and Gastrointestinal Surgery, Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine
| |
Collapse
|
10
|
Vaezi MF, Shaheen NJ, Muthusamy VR. State of Evidence in Minimally Invasive Management of Gastroesophageal Reflux: Findings of a Scoping Review. Gastroenterology 2020; 159:1504-1525. [PMID: 32621903 DOI: 10.1053/j.gastro.2020.05.097] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/28/2020] [Revised: 04/30/2020] [Accepted: 05/11/2020] [Indexed: 12/13/2022]
Abstract
BACKGROUNDS & AIMS Endoscopic management of gastroesophageal reflux disease (GERD) is being employed increasingly. The aim of this scoping review was to assess the volume of available evidence on the benefits of endoscopic and minimally invasive surgical therapies for GERD. METHODS criteria were used to perform an extensive literature search of data regarding the reported benefit of endoscopic therapies in GERD. Randomized controlled studies were utilized when available; however, data from observational studies were also reviewed. RESULTS A formal review of evidence was performed in 22 studies. Inclusion and exclusion criteria and study duration were noted and tabulated. Assessment of outcomes was based on symptoms and objective criteria reported by investigators. Reported outcomes for the interventions were tabulated under the heading of subjective (symptom scores, quality of life metrics, and change in proton pump inhibitor use) and objective metrics (pH parameters, endoscopic signs, and lower esophageal sphincter pressure changes). Adverse events were noted and tabulated. The majority of studies showed symptomatic and objective improvement of GERD with the device therapies. Adverse events were minimal. However, normalization of acid exposure occurred in about 50% of patients and, for some modalities, long-term durability is uncertain. CONCLUSIONS This scoping review revealed that the endoluminal and minimally invasive surgical devices for GERD therapy are a promising alternative to proton pump inhibitor therapy. Their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially durability of effect, are better understood.
Collapse
Affiliation(s)
- Michael F Vaezi
- Division of Gastroenterology, Hepatology, and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee.
| | - Nicholas J Shaheen
- Division of Gastroenterology, Hepatology, and Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | - V Raman Muthusamy
- Vatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California
| |
Collapse
|
11
|
Coronel MA, Bernardo WM, Moura DTHD, Moura ETHD, Ribeiro IB, Moura EGHD. THE EFFICACY OF THE DIFFERENT ENDOSCOPIC TREATMENTS VERSUS SHAM, PHARMACOLOGIC OR SURGICAL METHODS FOR CHRONIC GASTROESOPHAGEAL REFLUX DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS. ARQUIVOS DE GASTROENTEROLOGIA 2018; 55:296-305. [PMID: 30540095 DOI: 10.1590/s0004-2803.201800000-65] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/12/2018] [Accepted: 05/14/2018] [Indexed: 12/15/2022]
Abstract
BACKGROUND Endoscopic antireflux treatments for gastroesophageal reflux disease (GERD) are still evolving, and most of the published studies address symptom relief in the short-term. Objective - We aimed to perform a systematic review and meta-analysis focused on evaluating the efficacy of the different endoscopic procedures. METHODS Search was restricted to randomized controlled trials (RCTs) on MedLine, Cochrane, SciELO, and EMBASE for patients with chronic GERD (>6 months), over 18 years old and available follow up of at least 3 months. The main outcome was to evaluate the efficacy of the different endoscopic treatments compared to sham, pharmacological or surgical treatment. Efficacy was measured by different subjective and objective outcomes. RESULTS We analyzed data from 16 RCT, totaling 1085 patients. The efficacy of endoscopic treatments compared to sham and proton pump inhibitors (PPIs) treatment showed a significant difference up to 6 months in favor of endoscopy with no heterogeneity (P<0.00001) (I2: 0%). The subgroup analysis showed a statistically significant difference up to 6 months in favor of endoscopy: endoscopy vs PPI (P<0.00001) (I2: 39%). Endoscopy vs sham (P<0.00001) (I2: 0%). Most subjective and objective outcomes were statistically significant in favor of endoscopy up to 6 and 12 months follow up. CONCLUSION This systematic review and meta-analysis shows a good short-term efficacy in favor of endoscopic procedures when comparing them to a sham and pharmacological or surgical treatment. Data on long-term follow up is lacking and this should be explored in future studies.
Collapse
Affiliation(s)
- Martin Andrés Coronel
- Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Endoscopia Avançada Gastrointestinal, São Paulo, SP, Brasil
| | - Wanderley Marques Bernardo
- Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Endoscopia Avançada Gastrointestinal, São Paulo, SP, Brasil
| | - Diogo Turiani Hourneaux de Moura
- Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Endoscopia Avançada Gastrointestinal, São Paulo, SP, Brasil
| | - Eduardo Turiani Hourneaux de Moura
- Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Endoscopia Avançada Gastrointestinal, São Paulo, SP, Brasil
| | - Igor Braga Ribeiro
- Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Endoscopia Avançada Gastrointestinal, São Paulo, SP, Brasil
| | - Eduardo Guimarães Hourneaux de Moura
- Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Endoscopia Avançada Gastrointestinal, São Paulo, SP, Brasil
| |
Collapse
|
12
|
Puri R, Smith CD, Bowers SP. The Spectrum of Surgical Remediation of Transoral Incisionless Fundoplication-Related Failures. J Laparoendosc Adv Surg Tech A 2018; 28:1089-1093. [PMID: 29768079 DOI: 10.1089/lap.2018.0063] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
Abstract
AIM To evaluate outcomes of surgical remediation for symptomatic or anatomic failure after a transoral incisionless fundoplication (TIF). METHODS This retrospective study was performed on 11 patients who underwent a remedial operation following TIF failure between June 2011 and September 2016 at the Mayo Clinic in Florida for persistent foregut symptoms. Upper gastrointestinal workup characterized 1 patient as having normal post-TIF anatomy and 10 as having anatomic failure. Ambulatory pH testing was performed in 7 patients and was abnormal in all. All patients underwent a laparoscopic takedown of the prior endoscopic fundoplication and removal of all accessible polypropylene T-fasteners. RESULTS All patients had esophageal salvage and have not required a reoperation. Anatomical findings included hiatal hernia (7), esophageal diverticulum (2), hiatal mesh erosion of esophagus (1), long-segment esophageal stricture (1), and normal anatomy (1). Remedial operations included laparoscopic explant of fasteners in all patients with conversion to fundoplication (7), resection/imbrication of esophageal diverticulum (2), Heller myotomy (1), and mesh explant and complex esophageal repair (1). Mean operative time was 177 minutes and median length of stay 3 days (range 2-13 days). At mean follow-up of 10.7 months (range 1-42 months), 7 patients had persistent complaints. Esophagogastroduodenoscopy was repeated in these 7 patients and was normal (n = 3), mild stenosis requiring dilation (n = 2), Los Angeles grade B esophagitis (n = 1), and Barrett's esophagus (n = 1). CONCLUSION Anatomic distortion of the distal esophagus after TIF can be significant, making subsequent operations complex. After remedial surgery, few patients will continue to have troublesome symptoms such as dysphagia.
Collapse
Affiliation(s)
- Ruchir Puri
- 1 Department of Surgery, University of Florida , Jacksonville, Florida
| | | | - Steven P Bowers
- 3 Department of Surgery, Mayo Clinic , Jacksonville, Florida
| |
Collapse
|
13
|
De Moura EGH, Sallum RAA, Nasi A, Coronel M, De Moura DTH, De Moura ETH, Minata MK, Cury M, Falcão A, Cecconello I, Sakai P. Endoscopic polymer injection and endoluminal plication in treatment of gastroesophageal reflux disease: evaluation of long-term results. Endosc Int Open 2018; 6:E630-E636. [PMID: 29756023 PMCID: PMC5943693 DOI: 10.1055/a-0573-1194] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/31/2017] [Accepted: 01/03/2018] [Indexed: 12/11/2022] Open
Abstract
BACKGROUND AND STUDY AIMS Us of proton pump inhibitors (PPIs) has made endoscopic treatment of gastroesophageal reflux disease (GERD) more efficient, with reduction in morbidity and complications. However, some patients persist with symptoms despite medical treatment and some are not compliant with it or cannot afford it for financial reasons, and thus they require non-pharmacological therapeutic options such as surgical fundoplication. Surgery may be effective in the short term, but there is related morbidity and concern about its long-term efficacy. The possibility of minimally invasive endoluminal surgeries has resulted in interest in and development of newly endoscopic devices. Good short-term results with surgical fundoplication lack of studies of is with long follow-up justify our interest in this study. The aim of this study was to investigate the efficacy of endoscopic polymer injection and endoluminal full-thickness plication in the long-term control of GERD. PATIENTS AND METHODS Forty-seven patients with GERD who underwent an endoscopic procedure were followed up for 60 months and evaluated for total response (RT), partial response (RP) and no response (SR) to endoscopic treatment with reintroduction of PPIs. RESULTS Twenty-one patients received polymer injection (G0) and 26 endoluminal plication (G1). The number of patients with no response to endoscopic treatment with reintroduction of PPIs increased in time for both techniques (G0 P = 0.006; G1 P < 0.001). There was symptomatic improvement up to 12 months, with progressive loss of this trending up to 60 months in G0 and G1 ( P < 0.001). Health-related quality of life score (GERD-HRQL) demonstrated TR in G0 and G1 at 1, 3, 6 and 12 months. The 60-month analysis showed an increased number of patients with SR in both groups. The quality of life assessment (SF-36) showed benefit in G0 up to 3 months. G0 showed a higher rate of complications. There were no deaths. There was healing of esophagitis at 3 months in 45 % of patients in G0 and 40 % in G1. There was no improvement in manometric or pH findings. CONCLUSION Endoscopic therapies were ineffective in controlling GERD in the long term.
Collapse
Affiliation(s)
| | - Rubens A. A. Sallum
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Ary Nasi
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Martin Coronel
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil,Corresponding author Martin Coronel Universidade de São Paulo Faculdade de MedicinaGastrointestinal EndoscopyAv. Dr Enéas de Carvalho Aguiar 225
6
o
andar, bloco 3
Cerqueira Cezar ZIP Code 05403-010São Paulo, SP, Brazil+55-112-661-6467
| | - Diogo Turiani Hourneaux De Moura
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | | | - Mauricio Kazuyoshi Minata
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Marcelo Cury
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Angela Falcão
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Ivan Cecconello
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Paulo Sakai
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| |
Collapse
|
14
|
Preoperative diagnosis of hiatal hernia: barium swallow X-ray, high-resolution manometry, or endoscopy? Eur Surg 2017; 49:210-217. [PMID: 29104588 PMCID: PMC5653726 DOI: 10.1007/s10353-017-0492-y] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/23/2016] [Accepted: 09/04/2017] [Indexed: 01/08/2023]
Abstract
Background The assessment of hiatal hernias (HH) is typically done with barium swallow X‑ray, upper endoscopy, and by high-resolution esophageal manometry (HRM). The aim of this study was to assess the clinical utility of these methods in terms of HH detection and their correlation to gastroesophageal reflux disease (GERD). Methods A retrospective comparative analysis of patients with symptoms of GERD was carried out. The performance of endoscopy and HRM in diagnosing HH was assessed, taking barium swallow X‑ray as a reference. Furthermore, statistically comparative analysis between detected hernias and the presence of reflux disease in ambulatory impedance-pH monitoring (MII) was performed. Results Overall, 112 patients were analyzed. Barium swallow X‑ray showed no correlation either to HR manometrically or to endoscopically assessed HH. Significant accordance in the detection rate of HH was proved between HRM and gastroesophagoscopy (p < 0.001). Only endoscopically assessed HH showed a significant correlation with GERD (p = 0.047). No correlation between detected hernias and GERD could be found either with HRM or with barium swallow X‑ray. Conclusions Barium swallow X‑ray provided the highest rate of HH detection (76.8%). For the reliable exclusion of HH prior to treatment, all three mentioned investigations appear to be necessary in order of low conformity.
Collapse
|
15
|
Asche KU, Kaindlstorfer A, Pointner R. [Surgical and interventional procedures for reflux therapy : Endoscopic or laparoscopic?]. Chirurg 2017; 88:188-195. [PMID: 28180974 DOI: 10.1007/s00104-017-0369-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/24/2022]
Abstract
An optimal functioning of the gastroesophageal antireflux barrier depends on an anatomical overlapping of the lower esophageal sphincter and the crural diaphragm. Restoration of this situation is currently only possible by antireflux interventions combined with hiatoplasty and necessitates a laparoscopic approach. Newer alternative techniques to the generally accepted fundoplication are laparoscopic implantation of the LINX® device or the EndoStim® system and various endoscopic antireflux procedures, such as radiofrequency energy treatment, plication and implantation techniques aimed at augmentation of the gastroesophageal valve. Endoscopic techniques are becoming established more and more between pharmaceutical and surgical therapy instead of replacing them.
Collapse
Affiliation(s)
- K U Asche
- Allgemein- und Viszeralchirurgie, A.ö. Tauernklinikum GmbH Standort Zell am See, Paracelsusstr. 8, 5700, Zell am See, Österreich.
| | - A Kaindlstorfer
- Allgemein- und Viszeralchirurgie, A.ö. Tauernklinikum GmbH Standort Zell am See, Paracelsusstr. 8, 5700, Zell am See, Österreich
| | - R Pointner
- Allgemein- und Viszeralchirurgie, A.ö. Tauernklinikum GmbH Standort Zell am See, Paracelsusstr. 8, 5700, Zell am See, Österreich
| |
Collapse
|
16
|
Abstract
Over the past 2 decades, a number of new endoscopic techniques have been developed for management of gastroesophageal (GE) reflux disease symptoms as alternatives to medical management and surgical fundoplication. These devices include application of radiofrequency treatment (Stretta), endoscopic plication (EndoCinch, Plicator, Esophyx, MUSE), and injection of bulking agents (Enteryx, Gatekeeper, Plexiglas, Duragel). Their goal was symptom relief through reduction of tissue compliance and enhancement of anatomic resistance at the GE junction. In this review, we critically assess the research behind the efficacy, safety, and durability of these treatments to better understand their roles in contemporary GE reflux disease management.
Collapse
|