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Watson AC, Watson DI. Antireflux surgeries and hiatal repair: keys to success. Expert Rev Gastroenterol Hepatol 2025; 19:181-195. [PMID: 39910806 DOI: 10.1080/17474124.2025.2464039] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/19/2024] [Revised: 01/20/2025] [Accepted: 02/04/2025] [Indexed: 02/07/2025]
Abstract
INTRODUCTION Gastroesophageal reflux is common, and when medical therapy is ineffective, alternative treatments should be considered. Nissen fundoplication controls reflux but can be followed by side effects such as dysphagia and flatulence. To improve outcomes, modifications have been advocated. AREAS COVERED Modifications to Nissen fundoplication and newer procedures for gastroesophageal reflux aim to improve overall outcome. Randomized controlled trials (RCTs) and long-term outcomes from large cohorts are prioritized to consider the optimal procedure for reflux and hiatus hernia. EXPERT OPINION Fundoplication is an effective treatment for gastroesophageal reflux, with success rates of >80% reported at 18-20-year follow-up. RCTs confirm that Nissen fundoplication delivers better reflux control than medication. However, some patients are troubled by side effects. Anterior and posterior partial fundoplication variants have been proposed as procedures that offer equally good reflux control, but fewer side effects, and RCTs have confirmed this with follow-up to 20 years. Which partial fundoplication is better is debated. Alternative laparoscopic or endoscopic approaches require expensive implants or equipment and deliver less reliable reflux control than partial fundoplication. Currently, level I evidence confirms that laparoscopic partial fundoplication delivers the optimal outcome in fit patients with reflux that is not well controlled by medication.
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Affiliation(s)
- Abigail Claire Watson
- Discipline of Surgery, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia
| | - David Ian Watson
- Discipline of Surgery, College of Medicine and Public Health, Flinders University, Bedford Park, South Australia, Australia
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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.
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Endoluminal flexible endoscopic suturing for minimally invasive therapies. Gastrointest Endosc 2015; 81:262-9.e19. [PMID: 25440675 DOI: 10.1016/j.gie.2014.09.013] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/24/2014] [Accepted: 09/03/2014] [Indexed: 12/12/2022]
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Pandolfino JE, Krishnan K. Do endoscopic antireflux procedures fit in the current treatment paradigm of gastroesophageal reflux disease? Clin Gastroenterol Hepatol 2014; 12:544-54. [PMID: 23811248 PMCID: PMC3880639 DOI: 10.1016/j.cgh.2013.06.012] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/05/2013] [Revised: 06/06/2013] [Accepted: 06/08/2013] [Indexed: 12/12/2022]
Abstract
Gastroesophageal reflux disease (GERD) is a common condition requiring considerable medical resources. The mainstay of therapy is proton pump inhibitors (PPIs), which are effective at reducing acid reflux. In patients who have refractory acid reflux and esophagitis despite high-dose PPI, or are intolerant of the side effects of PPI therapy, surgical fundoplication is the primary therapy. The risk and cost gap between medical therapy and surgery has resulted in substantial interest in less-invasive endoscopic therapies. In this review, we discuss the underlying physiology of GERD along with the anatomic hurdles that must be overcome to develop an effective antireflux procedure. We also review the current published literature and assess the clinical efficacy of the devices that have been studied or currently are being investigated. Despite promising early studies, many of the devices fall short in high-quality randomized controlled trials. Furthermore, the physiologic aberration resulting in GERD oftentimes is addressed inadequately. Although there is certainly a need for less-invasive, safe, and effective therapy for reflux, therapy will need to withstand the established clinical efficacy of both PPI and surgical fundoplication. At present, we have the luxury of time to wait for such a device to become available.
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Affiliation(s)
- John E Pandolfino
- Department of Medicine, Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
| | - Kumar Krishnan
- Department of Medicine, Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, Illinois
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Schwartz MP, Schreinemakers JRC, Smout AJPM. Four-year follow-up of endoscopic gastroplication for the treatment of gastroesophageal reflux disease. World J Gastrointest Pharmacol Ther 2013; 4:120-126. [PMID: 24199028 PMCID: PMC3817287 DOI: 10.4292/wjgpt.v4.i4.120] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/13/2013] [Revised: 10/09/2013] [Accepted: 10/16/2013] [Indexed: 02/06/2023] Open
Abstract
AIM: To evaluate the long-term effect of Endocinch treatment for gastroesophageal reflux disease (GERD).
METHODS: After unblinding and crossover, 50 patients (32 males, 18 females; mean age 46 years) with pH-proven chronic GERD were recruited from an initial randomized, placebo-controlled, single-center study, and included in the present prospective open-label follow-up study. Initially, three gastroplications using the Endocinch device were placed under deep sedation in a standardized manner. Optional retreatment was offered in the first year with 1 or 2 extra gastroplications. At baseline, 3 mo after (re) treatment and yearly proton pump inhibitor (PPI) use, GERD symptoms, quality of life (QoL) scores, adverse events and treatment failures (defined as: patients using > 50% of their baseline PPI dose or receiving alternative antireflux therapy) were assessed. Intention-to-treat analysis was performed.
RESULTS: Median follow-up was 48 mo [interquartile range (IQR): 38-52]. Three patients were lost to follow-up. In 44% of patients retreatment was done after a median of 4 mo (IQR: 3-8). No serious adverse events occurred. At the end of follow-up, symptom scores and 4 out of 6 QoL subscales were improved (all P < 0.01 compared to baseline). However, 80% of patients required PPIs for their GERD symptoms. Ultimately, 64% of patients were classified as treatment failures. In 60% a post-procedural endoscopy was carried out, of which in 16% reflux esophagitis was diagnosed.
CONCLUSION: In the 4-year follow-up period, the subset of GERD patients that benefit from endoscopic gastroplication kept declining gradually, nearly half opted for retreatment and 80% required PPIs eventually.
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Woodland P, Amarasinghe G, Sifrim D. Emerging therapeutic options in GERD. Best Pract Res Clin Gastroenterol 2013; 27:455-67. [PMID: 23998982 DOI: 10.1016/j.bpg.2013.06.006] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/29/2013] [Revised: 06/16/2013] [Accepted: 06/23/2013] [Indexed: 01/31/2023]
Abstract
Gastroesophageal reflux disease (GERD) is a prevalent problem resulting in a high level of healthcare consultation and expenditure in the Western World. Although standard medical therapy (in the form of proton pump inhibitor drugs) is effective in the majority of cases, there remains a significant proportion who are refractory to treatment. In addition, surgical therapy (in the form of laparoscopic fundoplication) is not always effective, and in some can be associated with significant side-effects, particularly gas-bloat, flatulence and dysphagia. As such there remains an unmet need in GERD to develop new therapies for refractory cases, and to develop alternatives to fundoplication with fewer side-effects. This article discusses the current state of pharmacological and non-pharmacological emerging therapies for GERD.
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Affiliation(s)
- Philip Woodland
- Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
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Tokudome K, Funaki Y, Sasaki M, Izawa S, Tamura Y, Iida A, Ogasawara N, Konagaya T, Tokura Y, Kasugai K. Efficacy of endoluminal gastroplication in Japanese patients with proton pump inhibitor-resistant, non-erosive esophagitis. World J Gastroenterol 2012; 18:5940-7. [PMID: 23139611 PMCID: PMC3491602 DOI: 10.3748/wjg.v18.i41.5940] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/09/2012] [Revised: 07/16/2012] [Accepted: 07/18/2012] [Indexed: 02/06/2023] Open
Abstract
AIM: To evaluate the efficacy, safety, and long-term outcomes of endoluminal gastroplication (ELGP) in patients with proton pump inhibitor (PPI)-resistant, non-erosive reflux disease (NERD).
METHODS: The subjects were NERD patients, diagnosed by upper endoscopy before PPI use, who had symptoms such as heartburn or reflux sensations two or more times a week even after 8 wk of full-dose PPI treatment. Prior to ELGP, while continuing full-dose PPI medication, patients’ symptoms and quality of life (QOL) were assessed using the questionnaire for the diagnosis of reflux disease, the frequency scale for symptoms of gastro-esophageal reflux disease (FSSG), gastrointestinal symptoms rating scale, a 36-item short-form. In addition, 24-h esophageal pH monitoring or 24-h intraesophageal pH/impedance (MII-pH) monitoring was performed. The Bard EndoCinchTM was used for ELGP, and 2 or 3 plications were made. After ELGP, all acid reducers were temporarily discontinued, and medication was resumed depending on the development and severity of symptoms. Three mo after ELGP, symptoms, QOL, pH or MII-pH monitoring, number of plications, and PPI medication were evaluated. Further, symptoms, number of plications, and PPI medication were evaluated 12 mo after ELGP to investigate long-term effects.
RESULTS: The mean FSSG score decreased significantly from before ELGP to 3 and 12 mo after ELGP (19.1 ± 10.5 to 10.3 ± 7.4 and 9.3 ± 9.9, P < 0.05, respectively). The total number of plications decreased gradually at 3 and 12 mo after ELGP (2.4 ± 0.8 to 1.2 ± 0.8 and 0.8 ± 1.0, P < 0.05, respectively). The FSSG scores in cases with no remaining plications and in cases with one or more remaining plications were 4.4 and 2.7, respectively, after 3 mo, and 2.0 and 2.8, respectively, after 12 mo, showing no correlation to plication loss. On pH monitoring, there was no difference in the percent time pH < 4 from before ELGP to 3 mo after. Impedance monitoring revealed no changes in the number of reflux episodes or the symptom index for reflux events from before ELGP to 3 mo after, but the symptom sensitivity index decreased significantly 3 mo after ELGP (16.1 ± 12.9 to 3.9 ± 8.3, P < 0.01). At 3 mo after ELGP, 6 patients (31.6%) had reduced their PPI medication by 50% or more, and 11 patients (57.9%) were able to discontinue PPI medication altogether. After 12 mo, 3 patients (16.7%) were able to reduce the amount of PPI medication by 50% or more, and 12 patients (66.7%) were able to discontinue PPI medication altogether. A high percentage of cases with remaining plications had discontinued PPIs medication after 3 mo, but there was no difference after 12 mo. No serious complications were observed in this study.
CONCLUSION: ELGP was safe, resulted in significant improvement in subjective symptoms, and allowed less medication to be used over the long term in patients with PPI-refractory NERD.
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Zagol B, Mikami D. Advances in transoral fundoplication for oesophageal reflux. Dig Liver Dis 2011; 43:361-4. [PMID: 21382755 DOI: 10.1016/j.dld.2011.01.006] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/19/2010] [Accepted: 01/04/2011] [Indexed: 12/11/2022]
Abstract
BACKGROUND The purpose of this review was to evaluate transoral fundoplication devices for gastro-oesophageal reflux disease that have been commercially available within the last 5 years. METHODS Literature databases including Medline and Pubmed were searched from January 2005 to November 2010. Both blinded and unblinded randomized studies were evaluated. RESULTS We reviewed the literature for evaluations of primary transoral endoluminal fundoplication devices which included EndoCinch, NDO Plicator, Esophyx, and Stretta. Reviews of all studies with greater than 20 patients were evaluated to assess the efficacy and safety of transoral fundoplication devices. These endoluminal devices were primary matched against sham procedures. The EndoCinch and Stretta procedures were the only devices compared to laparoscopic fundoplication, the current standard for surgical management of gastro-oesophageal reflux disease. CONCLUSION The field of endoluminal treatment of gastro-oesophageal reflux disease has gained popularity over the last several years. Endoluminal treatment of gastro-oesophageal reflux disease has been shown to be safe and effective in recent studies. We still believe more randomized prospective studies need to be carried out to determine if endoluminal therapies will be a durable option for patients with gastro-oesophageal reflux disease. Continuing research will further the advancement of endoluminal gastro-oesophageal reflux disease procedures in the future.
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Affiliation(s)
- Bradley Zagol
- Division of General Surgery, The Ohio State University Hospitals, Columbus, OH, United States
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Louis H, Devière J. Ensocopic-endoluminal therapies. A critical appraisal. Best Pract Res Clin Gastroenterol 2010; 24:969-79. [PMID: 21126708 DOI: 10.1016/j.bpg.2010.10.002] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/05/2010] [Accepted: 10/07/2010] [Indexed: 02/06/2023]
Abstract
Due to its large prevalence, gastro-oesophageal reflux disease is an ideal target for companies developing medical devices designed to cure reflux. Indeed, because medications leave part of the patients unsatisfied, there is a potential place for alternative therapies, capable of restoring an efficacious anti-reflux barrier, but without the drawbacks of surgery. For more than a decade, several novel endoluminal therapies were developed, clinically evaluated, put on the market and, for many of them, withdrawn due to economic considerations, lack of efficacy or complications. These therapies were designed to act on the gastro-oesophageal junction and reinforce mechanically the anti-reflux barrier by three different ways: suturing, radiofrequency energy application, or implantation of foreign materials. Most of the published data come from open uncontrolled studies with short-term enthusiastic results. There are a few randomized control trials assessing the true efficacy of these modalities, showing often less impressive results than the open studies did, due to a high placebo effect in mild gastro-oesophageal reflux disease. Although endoscopic treatment of gastro-oesophageal disease is still an interesting topic of investigation, one can draw some lessons from the recent experiences and foresee which place these techniques could find in the management of patients suffering from reflux.
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Affiliation(s)
- Hubert Louis
- Department of Gastroenterology and Hepatopancreatology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
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Watson DI, Immanuel A. Endoscopic and laparoscopic treatment of gastroesophageal reflux. Expert Rev Gastroenterol Hepatol 2010; 4:235-43. [PMID: 20350269 DOI: 10.1586/egh.10.5] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
Gastroesophageal reflux is extremely common in Western countries. For selected patients, there is an established role for the surgical treatment of reflux, and possibly an emerging role for endoscopic antireflux procedures. Randomized trials have compared medical versus surgical management, laparoscopic versus open surgery and partial versus total fundoplications. However, the evidence base for endoscopic procedures is limited to some small sham-controlled studies, and cohort studies with short-term follow-up. Laparoscopic fundoplication has been shown to be an effective antireflux operation. It facilitates quicker convalescence and is associated with fewer complications, but has a similar longer term outcome compared with open antireflux surgery. In most randomized trials, antireflux surgery achieves at least as good control of reflux as medical therapy, and these studies support a wider application of surgery for the treatment of moderate-to-severe reflux. Laparoscopic partial fundoplication is an effective surgical procedure with fewer side effects, and it may achieve high rates of patient satisfaction at late follow-up. Many of the early endoscopic antireflux procedures have failed to achieve effective reflux control, and they have been withdrawn from the market. Newer procedures have the potential to fashion a surgical fundoplication. However, at present there is insufficient evidence to establish the safety and efficacy of endoscopic procedures for the treatment of gastroesophageal reflux, and no endoscopic procedure has achieved equivalent reflux control to that achieved by surgical fundoplication.
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Affiliation(s)
- David I Watson
- Flinders University Department of Surgery, Flinders Medical Centre, Bedford Park, South Australia 5042, Australia.
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Antireflux 'barriers': problems with patient recruitment for a new endoscopic antireflux procedure. Eur J Gastroenterol Hepatol 2009; 21:1110-8. [PMID: 19300273 DOI: 10.1097/meg.0b013e32832937c2] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
BACKGROUND Most first-generation endoscopic antireflux procedures (EARPs) have been withdrawn because of variable success rates, economic considerations, and/or complications. As a result, subsequent methods may meet 'skepticism' by physicians and patients. AIMS To identify potential barriers to patient recruitment for a new EARP METHODS: We prospectively analyzed our recruitment for a phase 2 study of a transoral incisionless fundoplication procedure. We contacted 50 private practices and 23 hospitals for potential referrals, and placed three newspaper advertisements. All patient replies were followed up by a phone call. Patients were then invited for a personal interview, and eligible patients underwent further preprocedure testing. In addition, poststudy questionnaires regarding their opinions about EARPs were sent to referring physicians. RESULTS Of 134 interviewed patients, only 10% (n=13) were successfully recruited. Candidates mostly responded to newspaper advertisements (87%) or were referred from our own institution (7%). Primary exclusion criteria included failure of proton pump inhibitor response (34%), lack of proton pump inhibitor use (20%), atypical symptoms (18%), or a large hiatal hernia (17%). Seventy percent of the responding physicians did not believe that new EARPs would be superior to previous methods. CONCLUSION The EARP market seems to be much smaller than anticipated, partially because of skepticism of referring physicians, and partially because of strict selection criteria.
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Ozawa S, Kumai K, Higuchi K, Arakawa T, Kato M, Asaka M, Katada N, Kuwano H, Kitajima M. Short-term and long-term outcome of endoluminal gastroplication for the treatment of GERD: the first multicenter trial in Japan. J Gastroenterol 2009; 44:675-84. [PMID: 19440812 DOI: 10.1007/s00535-009-0064-4] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/26/2008] [Accepted: 03/13/2009] [Indexed: 02/04/2023]
Abstract
PURPOSE Endoluminal gastroplication (ELGP) was the first endoscopic therapy for gastroesophageal reflux disease (GERD). Data on the long-term outcomes, including the plication status and data from Asian populations, are limited. The aim of this study was to evaluate the short-term and long-term effectiveness and safety of ELGP for GERD in the Japanese population. METHODS This was an open-label, prospective, multicenter trial of ELGP. Forty-eight patients with GERD were enrolled. The procedure involved placing circumferential plications 1-2 cm below the GE junction using the EndoCinch system. Outcome measurements were improvement of heartburn, medication use, endoscopic Los Angeles grade, durability of plications, 24-h esophageal acid exposure, esophageal manometry, and frequency of adverse events. RESULTS During the 24-month follow-up, the rate of complete resolution of heartburn ranged from 54 to 66%, the rate of discontinuation or reduction of PPI/H2RA use ranged from 65 to 76%, and the rate of endoscopic classification to grade O ranged from 66 to 81%. The status with more than one plication remaining was associated with higher rates of improvement of heartburn, PPI/H2RA use, and endoscopic findings as compared with those associated with the loss of all plications. A modest decrease of the esophageal acid exposure level, but no change of the manometric parameters, was observed after ELGP. No serious adverse events were observed. CONCLUSIONS In this 24-month follow-up study conducted in Japanese subjects, ELGP was found to be effective in about 60% of patients with GERD, and the procedure was safe.
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Affiliation(s)
- Soji Ozawa
- Department of General and Gastrointestinal Surgery, School of Medicine, Fujita Health University, 3-6-10 Otobashi, Nakagawa-ku, Nagoya, Aichi, 454-8509, Japan.
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Abstract
PURPOSE OF REVIEW We critically analyze existing endoscopy-based interventions for gastroesophageal reflux disease (GERD). The focus is on the effectiveness of available procedures and to delineate goals for future research. RECENT FINDINGS Recent evaluations of the EndoCinch system reveal poor long-term results and no significant improvement over sham therapy due to poor apposition of mucosa with stitches. Recent studies with transoral incisionless fundoplication demonstrate improvement in GERD symptoms, quality of life, esophageal acid exposure, esophagitis, resting lower esophageal sphincter pressure and medication use. The SRS endoscopic stapling system creates a partial fundoplication wrap, and a preliminary study demonstrated improved symptoms and acid exposure. The Stretta system delivers radiofrequency energy to the gastroesophageal junction. A large prospective series demonstrates sustained improvement in GERD symptoms, quality of life and proton pump inhibitor therapy elimination after radiofrequency ablation at the gastroesophageal junction. A sham-controlled study showed improvement in symptoms at 6 months. SUMMARY EndoCinch plication requires further study and modification of technique before it can be recommended for general clinical use. Transoral incisionless fundoplication is a very promising procedure in its early stages of development. Further evaluation of procedure safety and durability is needed. Radiofrequency ablation therapy has been reintroduced and may have potential in patients with refractory GERD.
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Chen D, Barber C, McLoughlin P, Thavaneswaran P, Jamieson GG, Maddern GJ. Systematic review of endoscopic treatments for gastro-oesophageal reflux disease. Br J Surg 2009; 96:128-36. [PMID: 19160349 DOI: 10.1002/bjs.6440] [Citation(s) in RCA: 46] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND The aim of this review was to assess the safety and efficacy of endoscopic procedures for gastro-oesophageal reflux disease. METHODS Literature databases including Medline, Embase and PubMed were searched up to May 2006 without language restriction. Randomized controlled trials and non-randomized comparative studies with at least ten patients in each study arm, and case series studies of at least ten patients, were included. RESULTS A total of 33 studies examining seven endoscopic procedures (Stretta procedure, Bard EndoCinch, Wilson-Cook Endoscopic Suturing Device, NDO Plicator, Enteryx, Gatekeeper Reflux Repair System and Plexiglas) were included in the review. Of the three procedures that were tested against sham controls (Stretta procedure, Bard EndoCinch and Enteryx), patient outcomes in the treatment group were either as good as, or significantly better than, those of control patients in terms of heartburn symptoms, quality of life and medication usage. However, for the two procedures that were tested against laparoscopic fundoplication (Stretta) procedure and Bard EndoCinch), outcomes for patients in the endoscopic group were either as good as, or inferior to, those for the laparoscopic group. CONCLUSION At present there is insufficient evidence to determine the safety and efficacy of endoscopic procedures for gastro-oesophageal reflux disease, particularly in the long term.
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Affiliation(s)
- D Chen
- Department of Surgery, University of Adelaide and The Queen Elizabeth Hospital, South Australia, Australia
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Transoral endoscopic fundoplication in the treatment of gastroesophageal reflux disease: the anatomic and physiologic basis for reconstruction of the esophagogastric junction using a novel device. Ann Surg 2008; 248:69-76. [PMID: 18580209 DOI: 10.1097/sla.0b013e31817c9630] [Citation(s) in RCA: 53] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Abstract
OBJECTIVE To determine the safety, mechanism of action, immediate postprocedural anatomic impact on the esophagogastric junction, and short-term efficacy of the first entirely endolumenal antireflux procedure. BACKGROUND A safe and effective endoscopic antireflux procedure remains elusive. Transoral endolumenal surgery has enormous potential for the treatment of gastroesophageal reflux disease (GERD) and other esophagogastric diseases. A canine model was used to study a novel endoscopic device, which allows for creation of an endoluminal fundoplication. METHODS The transoral incisionless fundoplication (TIF) was performed in 21 canines in a phase I feasibility and safety study, and in 21 canines in a phase II study that included a detailed objective assessment of the effects of 2 variants of the TIF procedure (TIF 1.0 and TIF 2.0) versus sham on esophageal physiology and esophagogastric junction (EGJ) anatomy. RESULTS In phase I, TIF provided a safe and feasible endolumenal therapy for GERD, with histologic data that demonstrated serosal fusion of approximated full-thickness tissue plications and durability of the fundoplication. TIF procedures effectively reduced cardia circumference and improved Hill classification grade. In phase II, the TIF 2.0 procedure achieved normalization of distal esophageal acid exposure and increased lower esophageal sphincter (LES) pressure and length based on objective testing over a 2-week period. TIF 2.0 demonstrated superior results to TIF 1.0, and valve appearance and location exhibited similarity to the Nissen fundoplication by vector volume analysis. CONCLUSIONS The TIF procedure is safe and results in a durable and functional fundoplication as well as a platform for further development and modification of the procedure, which can be use to impact outcome. This work provides the foundation for human translation and assessment of long-term outcomes.
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Mosler P, Aziz AMA, Hieston K, Filipi C, Lehman G. Evaluation of supplemental cautery during endoluminal gastroplication for the treatment of gastroesophageal reflux disease. Surg Endosc 2008; 22:2158-63. [PMID: 18629586 DOI: 10.1007/s00464-008-0011-0] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/24/2008] [Accepted: 05/01/2008] [Indexed: 12/19/2022]
Abstract
BACKGROUND Endoscopic suture plications at the cardia decreased gastroesophageal reflux disease (GERD) symptoms in short-term studies. Pull-through of submucosal sutures may lead to loss of efficacy. The application of cautery on mucosal surfaces may promote tissue adherence. This study aimed to compare the efficacy of endoluminal gastroplication (ELGP) using Endocinch with and without adjuvant cautery. METHODS Vertical plications were created using ELGP. Patients were randomized to either ELGP alone or ELGP with an adjuvant bicap cautery. Patients were blinded to their randomization category and encouraged to take antisecretory medications if needed. Heartburn was scored on a scale of 0 (none), 1 (occasional), 2 (frequent), or 3 (daily). Patients undergoing a second antireflux procedure during the follow-up period were considered study failures and scored 3. RESULTS Of the 18 patients enrolled in the study, 1 was lost to follow-up evaluation at 12 months and 2 could not be followed up at 24 months. The cautery group included 10 patients (9 men) with a mean age of 53.2 years. The group without cautery consisted of 8 patients (5 men) with a mean age of 50.4 years. The use of ELGP with cautery resulted in a trend toward greater improvement in several parameters (heartburn score, total percentage of time that pH was less than 4, and medication use) at 12 months than ELGP without cautery. These trends were not seen at 24 months, when all but 1 patient had ongoing symptoms, used daily proton pump inhibitor/H2-blocker, or went on to undergo a second antireflux procedure (2 Nissen and 3 Enteryx). CONCLUSIONS Cautery numerically improved plication persistence, decreased esophageal acid exposure, and improved symptoms at 1 year compared with sutures alone. Little or no long-term efficacy of ELGP with or without cautery was observed after 2 years of follow-up evaluation.
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Affiliation(s)
- Patrick Mosler
- Indiana University Medical Center, Indianapolis, IN, USA
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Rothstein RI. Endoscopic therapy of gastroesophageal reflux disease: outcomes of the randomized-controlled trials done to date. J Clin Gastroenterol 2008; 42:594-602. [PMID: 18364577 DOI: 10.1097/mcg.0b013e31816bcde5] [Citation(s) in RCA: 31] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/07/2023]
Abstract
Endoscopic therapies to treat gastroesophageal reflux disease have been developed as another option for patients with reflux symptoms who do not want to continue medications indefinitely or are unwilling to undergo surgical intervention. The endoscopic treatments can be divided into those that pleat or plicate the upper stomach, deliver thermal energy into the lower esophageal sphincter, or inject or implant biopolymers into the gastroesophageal junction. Although capable to improve reflux symptoms for the majority of treated patients for a short while, durability has been variable among the various treatments, and there have been safety issues with some of the therapies. Although symptom improvement has been universally shown in short-term follow-up, there has been variable outcome for reduced need of antisecretory medications and pH studies show normalization of the distal esophageal acid exposure for only the minority of treated patients. Patients with significant reflux esophagitis or Barrett esophagus are not typically candidates for this antireflux intervention. Except for the NDO Plicator, in sham-controlled studies, there have been no significant differences between treated and sham-treated individuals for ability to discontinue medications or normalize pH. One issue in interpreting the results of these preliminary studies is the influence of the learning curve of a new technology. Another is that the devices and techniques have not been optimized. Currently, only the Davol/Bard EndoCinch and the NDO Plicator are available for commercial use. There are several newer devices under study or in development, and further testing and experience will demonstrate their capabilities in the treatment of gastroesophageal reflux disease.
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Affiliation(s)
- Richard I Rothstein
- Section of Gastroenterology and Hepatology, Dartmouth Medical School, Lebanon, NH 03756, USA.
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Liao CC, Lee CL, Lin BR, Bai CH, Hsieh YH, Wu CH, Gostout CJ. Endoluminal gastroplication for the treatment of gastroesophageal reflux disease: a 2-year prospective pilot study from Taiwan. J Gastroenterol Hepatol 2008; 23:398-405. [PMID: 18318824 DOI: 10.1111/j.1440-1746.2007.04906.x] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/28/2023]
Abstract
BACKGROUND AND AIM Endoluminal gastroplication (ELGP) offers a minimally invasive option for the treatment of gastroesophageal reflux disease (GERD) in Western countries. However, long-term outcomes of ELGP in Asian populations have not been investigated. The aim of this prospective study was to evaluate the long-term benefits of ELGP in Asian patients with GERD. METHODS Taiwanese patients diagnosed with GERD were enrolled and had the procedure performed with EndoCinch. The assessment included symptom scoring, validated GERD questionnaires, esophagogastroduodenoscopy, esophageal manometry and 24-h pH monitoring before and after the procedure over a 2-year period. RESULTS Twenty-one consecutive patients were recruited and underwent ELGP. Patients reported improved heartburn symptom score (mean 64.0 vs 21.1, P < 0.001), regurgitation frequency score (mean 2.4 vs 1.3, P < 0.001), and GERD health-related quality of life (mean 23.1 vs 10.1, P < 0.001) at 24 months. The mean total time of pH < 4 reduced from 121.7 min to 67.1 min (P = 0.008) and mean DeMeester score reduced from 32.9 to 17.6 (P = 0.011) at 3 months. Antisecretory drug discontinuation rate was 81%, 57%, 52% and 48% at 1, 6, 12 and 24 months, respectively. Of the patients who had a favorable initial response to ELGP at 1 month, 41% resumed antisecretory medications at 24 months follow-up. All adverse events were mild and transient. CONCLUSIONS Endoluminal gastroplication is a safe and modestly effective endotherapy for patients with GERD. It significantly improved symptoms in an Asian population. Approximately one in two patients continues to be off medication at 24 months follow-up. However, the long-term efficacy and durability are still to be determined.
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Affiliation(s)
- Chien-Chung Liao
- Division of Gastroenterology, Department of Internal Medicine, Cathay General Hospital, Hsinchu, and School of Medicine, China Medical University, Taichung, Taiwan
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Pace F, Costamagna G, Penagini R, Repici A, Annese V. Review article: endoscopic antireflux procedures - an unfulfilled promise? Aliment Pharmacol Ther 2008; 27:375-84. [PMID: 18162082 DOI: 10.1111/j.1365-2036.2007.03593.x] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND Most published reviews concerning the endoscopic treatment of gastro-oesophageal reflux disease date back to 2005. AIM To provide an updated review that includes all papers published up to 2007. METHODS A Medline search from January 2005 to June 2007 was performed regarding endoscopic procedures aiming at treating gastro-oesophageal reflux disease. In addition, we retrieved the abstracts presented at Digestive Disease Week during the last 3 years. We included in the review both 'mechanistic' studies - that is, papers exploring the potential mechanism of action of the procedure/device - and studies trying to assess its clinical efficacy. RESULTS During the last 3 years, the number of published papers has declined, and some devices are not available any more. The alleged mechanism(s) of action of the various devices or procedures is (are) still not completely elucidated; however, some concerns have arisen as far as durability and potential detrimental effects. Moreover, all the aspects of endoscopic therapy, except for its safety, are either insufficiently explored or not investigated at all, or assessed only in particularly selected patient subgroups. CONCLUSIONS None of the proposed antireflux therapies has fulfilled the criteria of efficacy, safety, cost, durability and, possibly, of reversibility. There is at present no definite indication for endoscopic therapy of gastro-oesophageal reflux disease. We suggest a list of recommendations to be followed when a new endoscopic therapeutic procedure is to be assessed for use in clinical practice.
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Affiliation(s)
- F Pace
- U.O. e Cattedra di Gastroenterologia, Ospedale Universitario L. Sacco, Milan, Italy.
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Abstract
OBJECTIVE Endoluminal gastroplication (EG) is emerging as a minimally invasive procedure for the treatment of gastroesophageal reflux disease (GERD). The aim of this study is to evaluate the medium-term outcomes after EG in a pediatric patient population. PATIENTS AND METHODS Seventeen children with a median age of 12.4 years (range 6.1-15.9 years) with GERD underwent EG using a flexible endoscopic sewing device (EndoCinch) over a period of 3 years. Three plications were placed in the gastric tissue below the lower esophageal sphincter. Drug dose requirement, pH measurements, symptom severity and frequency, and validated Quality of Life in Reflux and Dyspepsia (QOLRAD) scores were compared before EG and 1 and 3 years after EG. Statistical analysis was performed using a Wilcoxon rank-sum test and P < 0.05 was the threshold for significance. RESULTS All patients showed an immediate posttreatment improvement in symptom severity, symptom frequency, and quality of life scores. Completed 1- and 3-year data were obtained from 16 patients. Four cases (25%) required a repeat procedure as a result of recurrence of symptoms after 2 to 24 months. Fourteen patients (88%) at 1 year and 9 patients (56%) at 3 years remained without a need for any antireflux medication. A sustained improvement in heartburn (P = 0.004), regurgitation (P = 0.017), and vomiting (P = 0.018) was seen at 3 years. The total QOLRAD score (maximum of 175) improved from a median of 87 (range 69-142) to 156 (range 111-175) at 1 year (P < 0.0001) and 153.5 (range 55-174) at 3 years (P = 0.002). CONCLUSIONS EG is an effective and safe procedure in children. It is a viable option for the treatment of GERD refractory to or dependent on antireflux medications.
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Paulssen EJ, Lindsetmo RO. Long-term outcome of endoluminal gastroplication in the treatment of gastro-oesophageal reflux disease: effect of a second procedure. Scand J Gastroenterol 2008; 43:5-12. [PMID: 18938771 DOI: 10.1080/00365520701514560] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
OBJECTIVE Endoluminal gastroplication has been used with limited success for the treatment of gastro-oesophageal reflux disease (GORD). This method was used in 119 patients with GORD, and the results from short-term and long-term followup of symptoms and the use of acid suppression medication are reported. The purpose of this study was also to report on the effect of a second procedure on selected patients. MATERIAL AND METHODS The Bard EndoCinch endosuturing system was used for all procedures. Data were recorded at 3 and 12 months, and symptoms and medication use were registered by means of a telephone survey after an average of 41 months (range 27-55 months). A second procedure was carried out in 20 of the initial patients, and mean follow-up time was 39 months (range 15-51 months). RESULTS There were very few complications of the procedure. Heartburn severity score was reduced from an initial 21.4 to 12.4 (p < 0.01) and 13.4 (p < 0.01) at 3 and 12 months, respectively, corresponding to a reduction in the use of acid suppression from 8.7 doses per week (DD/w) to 4.0 (p < 0.01) and 5.6 DD/w (p < 0.01). At long-term follow-up there was a return towards baseline values for acid suppression use (6.4 DD/w, p = 0.06), whereas the heartburn severity score remained low (8.5, p < 0.01). Loss of sutures was significant, from an average of 2.51 applied sutures to 1.87 (p < 0.01) and 1.81 (p < 0.01) remaining sutures at 3 and 12 months, respectively. After the second procedure, the heartburn severity score fell from an initial 22.5 to 12.7 (p < 0.01) after 3 months and remained low at long-term follow-up (6.6, p < 0.01). The corresponding data for acid suppression use were 11.7, 3.6 (p < 0.01) and 5.2 (p < 0.01) DD/w. Number of sutures increased from an average of 2.15 sutures placed initially, with 2.65 sutures added at the second procedure, to an average of 2.80 remaining sutures (p < 0.01) at 3 months. CONCLUSIONS Endoluminal gastroplication has a significant, yet transient effect on symptom score and the use of acid suppressants in GORD patients. A selection of patients for a subsequent procedure may be of value.
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Affiliation(s)
- Eyvind J Paulssen
- Department of Gastroenterology, University Hospital of North Norway, Tromsø, Norway.
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Fock KM, Talley NJ, Fass R, Goh KL, Katelaris P, Hunt R, Hongo M, Ang TL, Holtmann G, Nandurkar S, Lin SR, Wong BCY, Chan FKL, Rani AA, Bak YT, Sollano J, Ho KY, Manatsathit S, Manatsathit S. Asia-Pacific consensus on the management of gastroesophageal reflux disease: update. J Gastroenterol Hepatol 2008; 23:8-22. [PMID: 18171339 DOI: 10.1111/j.1440-1746.2007.05249.x] [Citation(s) in RCA: 118] [Impact Index Per Article: 6.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
BACKGROUND AND AIMS Since the publication of the Asia-Pacific GERD consensus in 2004, more data concerning the epidemiology and management of gastroesophageal reflux disease (GERD) have emerged. An evidence based review and update was needed. METHODS A multidisciplinary group developed consensus statements using the Delphi approach. Relevant data were presented, and the quality of evidence, strength of recommendation, and level of consensus were graded. RESULTS GERD is increasing in frequency in Asia. Risk factors include older age, male sex, race, family history, higher socioeconomic status, increased body mass index, and smoking. Symptomatic response to a proton pump inhibitor (PPI) test is diagnostic in patients with typical symptoms if alarm symptoms are absent. A negative pH study off therapy excludes GERD if a PPI test fails. The role for narrow band imaging, capsule endoscopy, and wireless pH monitoring has not yet been undefined. Diagnostic strategies in Asia must consider coexistent gastric cancer and peptic ulcer. Weight loss and elevation of head of bed improve reflux symptoms. PPIs are the most effective medical treatment. On-demand therapy is appropriate for nonerosive reflux disease (NERD) patients. Patients with chronic cough, laryngitis, and typical GERD symptoms should be offered twice daily PPI therapy after excluding non-GERD etiologies. Fundoplication could be offered to GERD patients when an experienced surgeon is available. Endoscopic treatment of GERD should not be offered outside clinical trials. CONCLUSIONS Further studies are needed to clarify the role of newer diagnostic modalities and endoscopic therapy. Diagnostic strategies for GERD in Asia must consider coexistent gastric cancer and peptic ulcer. PPIs remain the cornerstone of therapy.
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Affiliation(s)
- Kwong Ming Fock
- Division of Gastroenterology, Department of Medicine, Changi General Hospital, Singapore.
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Schwartz MP, Smout AJPM. Review article: The endoscopic treatment of gastro-oesophageal reflux disease. Aliment Pharmacol Ther 2007; 26 Suppl 2:1-6. [PMID: 18081642 DOI: 10.1111/j.1365-2036.2007.03473.x] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
BACKGROUND Over the last 10 years a number of endoscopic procedures for treating gastro-oesophageal reflux disease (GORD) have been developed (suturing, injections, implants and radiofrequency ablation), thus obviating the need for long-term proton pump inhibitors (PPI) and the potential morbidity of laparoscopic fundoplication. AIM To present an update of the literature studying the clinical efficacy of endoscopic antireflux procedures, and to discuss further developments. METHODS A PubMed search was performed for endoscopic suturing, antireflux treatment, endoscopic gastroplication, polymer injection, radiofrequency ablation of GORD. Own recent research was compared with existing data. Information concerning GORD endotherapy were gathered. RESULTS Uncontrolled studies have reported promising clinical results on the short to intermediate term for most endoscopic GORD procedures, but the placebo effect remained unknown. It is, therefore, commendable that the three main procedures (Endocinch, Stretta and Enteryx) have now all been tested against a sham procedure. Although all three techniques were able to improve symptoms, quality of life and PPI use, oesophageal acid reduction was unremarkable. Endocinch and Stretta are safe outpatient procedures. Concerns about the durability of Endocinch have risen. Polymer injection (Enteryx) and gel prosthesis implantation (Gatekeeper) were recalled for severe complications and lack of efficacy, respectively. CONCLUSIONS Endotherapy has shown the potential to treat (uncomplicated) GORD. However, some early procedures have failed or proven unsafe. Further developments and studies are necessary to determine what modifications to these techniques are required to produce optimal efficacy and durability. Until then, widespread clinical use of endotherapy for GORD should probably be avoided.
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Affiliation(s)
- M P Schwartz
- Department of Gastroenterology, Meander Medical Centre, Amersfoort, The Netherlands.
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Systematic review: endoluminal therapy for gastro-oesophageal reflux disease: evidence from clinical trials. Eur J Gastroenterol Hepatol 2007; 19:1125-39. [PMID: 17998840 DOI: 10.1097/meg.0b013e3282f16a21] [Citation(s) in RCA: 28] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Abstract
During the last few decades many endoscopic interventions have been developed as an alternative for the treatment of gastro-oesophageal reflux disease (GORD). In many countries, these interventions are thus being performed in the general clinical setting. The aim of this study is to systematically review the evidence on the effect of endoscopic therapies for GORD. A systematic search of the literature on this subject in English, indexed in MEDLINE (1966 to May 2007) and in the Cochrane Library, was carried out. For the study selection, retrospective and prospective open-label and randomized, sham-controlled trials were taken into account. The exclusion criteria included the following: case series that included fewer than 10 patients, abstracts, studies involving children or those with a follow-up shorter than 3 months. For data extraction, two reviewers, using standardized forms, independently abstracted data on study design and methods, population, sample size, function studies (e.g. pH-metry), type of endoscopic treatment, follow-up, health-related and quality of life scores, outcomes and complications. Data synthesis involved the following: 43 studies, including four randomized, sham-controlled trials that met the inclusion criteria, out of 4182 citations. The primary end point in most studies was the reduction of the use of proton pump inhibitors (PPIs) by more than 50%. In view of these findings, the majority of studies suggested the efficacy of endoluminal therapies for the control of symptoms in GORD. In the sham-controlled studies, the effect of placebo was, nevertheless, as high as 50%. Most studies were small feasibility studies, with follow-ups of less than 1 year. No study comparing endoscopic techniques with other established treatment options such as PPIs existed. All endoscopic therapies were associated with a small but important percentage of mild to severe complications, which included perforation, abscess and death. In conclusion, the data from most of the short-term follow-up and the few sham-controlled studies demonstrate that subgroups of patients experienced improvement or resolution of typical GORD symptoms and decreased PPI usage. Currently, however, there are not enough scientific and clinical data on safety, efficacy and durability to support the use of endoluminal therapies for GORD in routine clinical practice.
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Laparoscopic conversion of failed gastric bypass to duodenal switch: technical considerations and preliminary outcomes. Surg Obes Relat Dis 2007; 3:611-8. [DOI: 10.1016/j.soard.2007.07.010] [Citation(s) in RCA: 93] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/27/2007] [Revised: 06/26/2007] [Accepted: 07/12/2007] [Indexed: 11/18/2022]
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Conchillo JM, Schwartz MP, Selimah M, Samsom M, Arts J, Tack J, Sifrim D, Smout AJPM. Role of intra-oesophageal impedance monitoring in the evaluation of endoscopic gastroplication for gastro-oesophageal reflux disease. Aliment Pharmacol Ther 2007; 26:61-8. [PMID: 17555422 DOI: 10.1111/j.1365-2036.2007.03353.x] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Abstract
BACKGROUND In the evaluation of several endoscopic antireflux procedures, a discrepancy in the degree of improvement between symptoms and objective reflux parameters as measured by pH-metry has been reported. AIM To assess the additional value of impedance monitoring in the evaluation of endoscopic gastroplication for gastro-oesophageal reflux disease. METHODS Eighteen patients with gastro-oesophageal reflux disease were treated with three endoscopic gastroplications, and underwent 24 h pH-impedance monitoring before and 3 months after treatment. RESULTS Total reflux exposure time as assessed by pH-metry and impedance monitoring was significantly decreased after treatment (P = 0.047 and <0.001, respectively). When assessed with impedance monitoring, the mean number of reflux episodes was significantly decreased after the procedure (82 vs. 56, pre vs. post, P < 0.001). Furthermore, the mean numbers of liquid and acid reflux episodes in patients with symptomatic improvement were significantly reduced after treatment (P = 0.04 and 0.02, respectively). After treatment, mean volume clearance time (s) and mean number of proximal reflux episodes were significantly decreased (P < 0.001 and 0.002, respectively). CONCLUSIONS Impedance monitoring can identify the specific effect of endoscopic gastroplication on the different types of reflux episodes with regard to gas-liquid composition and pH, as well as on volume clearance and the proximal extent of the refluxate.
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Affiliation(s)
- J M Conchillo
- Department of Gastroenterology and Hepatology, University Medical Center, Utrecht, The Netherlands.
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Abstract
In GERD patients in whom pharmacological therapies are ineffective and anti-reflux surgery is not indicated, a viable option could be proposed. To date, several endoscopic antireflux procedures, involving sewing, injection and/or implant, and radiofrequency are available. The sewing techniques demonstrated good clinical results, with reduction in proton pump inhibitors consumption; despite significant changes in esophageal manometry and/or acid exposure time reduction and healing of esophagitis were noted only in few patients.
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Affiliation(s)
- Michele Marchese
- Digestive Endoscopy Unit, Catholic University of Rome, Largo Francesco Vito 1, 00168 Rome, Italy
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Kantsevoy SV, Hu B, Jagannath SB, Isakovich NV, Chung SSC, Cotton PB, Gostout CJ, Hawes RH, Pasricha PJ, Nakajima Y, Kawashima K, Kalloo AN. Technical feasibility of endoscopic gastric reduction: a pilot study in a porcine model. Gastrointest Endosc 2007; 65:510-3. [PMID: 17321257 DOI: 10.1016/j.gie.2006.07.045] [Citation(s) in RCA: 32] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/21/2006] [Accepted: 07/20/2006] [Indexed: 12/10/2022]
Abstract
BACKGROUND Gastric restrictive procedures are widely used for the surgical treatment of morbid obesity. OBJECTIVE Our purpose was to determine the technical feasibility of endoscopic gastric reduction in a live porcine model. SETTING Acute experiments on 50-kg pigs under general anesthesia. DESIGN AND INTERVENTIONS After per-oral intubation, the endoscope was inserted into the stomach. A fishing line was sutured to the gastric wall along the fundus approximately 5 cm below the gastroesophageal junction with a prototype endoscopic suturing device (Olympus, Eagle Claw). Then the fishing line was tied to create a small proximal pouch. A flexible sheath was placed on one side of fishing line and additional knots were tied, forming a ring at the outlet of the gastric pouch. The ring was anchored to gastric wall with additional stitches, completing the gastric reduction. Then the animals were killed for postmortem examination. MAIN OUTCOME MEASUREMENTS The feasibility of endoscopic gastric reduction. RESULTS We performed 4 acute experiments. It required 12 to 14 stitches in each animal to create gastric reduction. There were no technical problems during the procedures. Postmortem examination demonstrated an approximately 30-mL gastric pouch separated from the rest of the stomach by the line of stitches. There were no complications during the procedure. LIMITATIONS We have not performed survival experiments to determine how long our gastric reduction will last. CONCLUSIONS Endoscopic gastric reduction is technically feasible on a live porcine model.
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Affiliation(s)
- Sergey V Kantsevoy
- Division of Gastroenterology, Johns Hopkins University, 1830 E. Monument Street, Baltimore, MD 21205, USA
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Falk GW, Fennerty MB, Rothstein RI. AGA Institute technical review on the use of endoscopic therapy for gastroesophageal reflux disease. Gastroenterology 2006; 131:1315-36. [PMID: 17030199 DOI: 10.1053/j.gastro.2006.08.019] [Citation(s) in RCA: 47] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Affiliation(s)
- Gary W Falk
- Department of Gastroenterology and Hepatology, Center for Swallowing and Esophageal Disorders, Cleveland Clinic, Cleveland, OH, USA
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31
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32
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von Rahden BHA, Stein HJ. Endoscopic treatment modalities for gastroesophageal reflux disease (GERD). Eur Surg 2006. [DOI: 10.1007/s10353-006-0263-7] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
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Abstract
PURPOSE OF REVIEW Endoscopic antireflux procedures have generated much interest among clinicians and patients. These devices utilize a variety of methods in an attempt to decrease reflux of gastric contents. This work reviews the most notable results of endoscopic antireflux procedure studies published in 2005. RECENT FINDINGS A variety of studies of different technologies have been published this year. Only a few of these studies report data beyond 12 months to establish longer term efficacy. One sham controlled multicenter trial was published this year. After case reports of complications related to Enteryx (Boston Scientific Corp, Natick, Massachusetts, USA) use, this US Food and Drug Administration-approved device was voluntarily removed from the market. SUMMARY A review of the literature demonstrates a paucity of long-term studies, as well as a lack of data comparing the devices to active medical therapy. The majority of studies are open-label trials with subjective endpoints, and such study designs are very susceptible to placebo effect. No one technology has demonstrated superiority to another. Additional studies with vigorous attention to methodology, safety evaluation, cost analysis and clinically meaningful endpoints will be required.
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Affiliation(s)
- Joseph E Cassara
- Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, University of North Carolina Schools of Medicine and Public Health, Chapel Hill, North Carolina, USA.
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Coron E, Hatlebakk JG, Galmiche JP. Novel developments in non-erosive and erosive gastroesophageal reflux disease. Curr Opin Gastroenterol 2006; 22:399-405. [PMID: 16760757 DOI: 10.1097/01.mog.0000231815.41267.f4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
PURPOSE OF REVIEW Despite being clinically important and highly prevalent, several aspects of gastroesophageal reflux disease are incompletely understood. Research activity remains high, however, and we shall review some highlights from last year's publications. RECENT FINDINGS Community based epidemiological studies have elucidated the risk factors for gastroesophageal reflux disease and demonstrated a significant risk for developing complications over time. New histological parameters such as distended intercellular spaces in the epithelium will detect minor signs of reflux damage. The esophageal endoscopic capsule has been studied as a way of screening for esophageal disease. Wireless pH-metry and impedance-pH-metry have increased our insight into the pathophysiology and improved the diagnostic work-up in atypical and therapy resistant cases. At the molecular level, the role of cytokines has been elucidated and there is increased support for the nitrosative stress theory for epithelial damage at the cardia. Endoscopic therapies have shown disappointing long-term results or safety concerns, leading to withdrawal of several methods. SUMMARY The last year has brought significant development in diagnostic modalities, and increased our insight in the molecular events involved in the pathogenesis of gastroesophageal reflux disease. Ultimately, this may and must lead to new therapeutic modalities which will supplement proton pump inhibitors in medical therapy for gastroesophageal reflux disease.
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Affiliation(s)
- Emmanuel Coron
- Department of Gastroenterology and Hepatology, University Hospital, Nantes, France
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Hogan WJ. Clinical trials evaluating endoscopic GERD treatments: is it time for a moratorium on the clinical use of these procedures? Am J Gastroenterol 2006; 101:437-9. [PMID: 16542277 DOI: 10.1111/j.1572-0241.2006.00523.x] [Citation(s) in RCA: 44] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
Perendoscopic treatments of gastroesophageal reflux have been used in clinical practice following FDA approval of the first two devices in 2000. A number of clinical trials predominantly short-term have been performed almost uniformly demonstrating patient improvement in GERD symptomatology and reduction or elimination of antacids. However, only two of these endo reflux treatment trials have included the essential elements of strict patient entry criteria, randomization, attempts at blending, and intention-to-treat analysis. Two new endoscopic antireflux trials are published in this issue of the journal. The first study compares the EndoCinch sewing device to the Enteryx copolymer injection procedure. The second report compares the EndoCinch technique to the laparoscopic fundoplication procedure. Unfortunately, both studies lack a sham-control population and have other important flaws in design. Basically, all these techniques improved GERD symptoms and well-being and decreased the patients PPI requirement during follow-up period. However, none of the endoscopic procedures reduced acid reflux impressively or improved lower esophageal sphincter tone, a consistent negative outcome with all these techniques. Morbidity was associated with all the procedures and Enteryx has been withdrawn recently from clinical use by the manufacturer because of significant complications. The efficacy durability and safety of these devices in treating GERD patients is in question. A moratorium on the continued use of the procedures in clinical practice seems appropriate at this time.
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Domagk D, Menzel J, Seidel M, Ullerich H, Pohle T, Heinecke A, Domschke W, Kucharzik T. Endoluminal gastroplasty (EndoCinch) versus endoscopic polymer implantation (Enteryx) for treatment of gastroesophageal reflux disease: 6-month results of a prospective, randomized trial. Am J Gastroenterol 2006; 101:422-30. [PMID: 16542275 DOI: 10.1111/j.1572-0241.2006.00533.x] [Citation(s) in RCA: 18] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVES The aim of this study was to compare and determine the efficiency and safety of two newly introduced endoscopic antireflux procedures in the treatment of gastroesophageal reflux disease (GERD). METHODS In a prospective, randomized trial, endoluminal gastroplasty (EndoCinch) was compared with polymer injection (Enteryx) employing 51 consecutive patients dependent on proton pump inhibitor therapy. Follow-up evaluation included drug consumption, symptoms, quality-of-life scoring, endoscopy, pH monitoring, manometry, and documentation of adverse events. RESULTS Twenty-six patients were assigned to EndoCinch treatment, 23 patients received Enteryx implantation, and two patients dropped out before applying endoscopic therapy. At 6 months, proton pump inhibitor therapy could be stopped or dosage was reduced by > or =50% in 20 of 26 (77%) EndoCinch-treated patients and in 20 of 23 patients treated by Enteryx (87%, p= 0.365), which differed significantly in both groups compared to the pre-interventional status (p < 0.0001). Esophageal acid reflux (pH < 4) decreased from 14.5% to 9.6% in EndoCinch-treated patients (p= 0.071) and from 15.5% to 13.9% in patients treated by Enteryx (p= 0.930). Heartburn symptom score, modified DeMeester score, gastrointestinal life quality index, and SF-36 physical health survey score improved significantly in both groups postinterventionally (p < 0.0001). Approximately 25% of the patients in both groups required retreatment in an attempt to achieve symptom control. CONCLUSIONS This is the first prospective, randomized study directly comparing two endoscopic anti-GERD techniques. EndoCinch and Enteryx seem to be equally successful in the treatment of GERD significantly reducing the proton pump inhibitor dosages, and also by improving symptoms of patients. Both endoluminal antireflux procedures may be promising therapeutic options; long-term evaluation will have to show if the positive initial results can be maintained.
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Affiliation(s)
- Dirk Domagk
- Department of Medicine B, University of Muenster, Albert-Schweitzer-Strasse 33, D-48129 Muenster, Germany
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Hongo M. How safe and effective is endoscopic full-thickness plication for the treatment of patients with GERD? NATURE CLINICAL PRACTICE. GASTROENTEROLOGY & HEPATOLOGY 2005; 2:514-5. [PMID: 16355156 DOI: 10.1038/ncpgasthep0319] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/23/2005] [Accepted: 09/21/2005] [Indexed: 05/05/2023]
Affiliation(s)
- Michio Hongo
- Department of Comprehensive Medicine, Tohoku University Hospital, Sendai, Japan.
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