Endoscopic therapies of gastroesophageal reflux disease

The high prevalence of gastroesophageal reflux disease (GERD) in Western societies has accelerated the need for new modalities of treatment. Currently, medical and surgical therapies are widely accepted among patients and physicians. New potent antisecretory drugs and the development of minimally invasive surgery for the management of GERD are at present the pivotal and largely accepted approaches to treatment. The minimally invasive treatment revolution, however, has stimulated several new endoscopic techniques for GERD. Up to now, the data is limited and further studies are necessary to compare the advantages and disadvantages of the various endoscopic techniques to medical and laparoscopic management of GERD. New journal articles and abstracts are continuously being published. The Food and Drug Administration has approved 3 modalities, thus gastroenterologists and surgeons are beginning to apply these techniques. Further trials and device refinements will assist clinicians. This article will present an overview of the various techniques that are currently on study. This review will report the efficacy and durability of various endoscopic therapies for gastroesophageal reflux disease (GERD). The potential for widespread use of these techniques will also be discussed. Articles and abstracts published in English on this topic were retrieved from Pubmed. Due to limited number of studies and remarkable differences between various trials, strict criteria were not used for the pooled data presented, however, an effort was made to avoid bias by including only studies that used off-PPI scoring as baseline and intent to treat.     

Endoscopic therapy for gastroesophageal reflux disease: a systematic review

The high prevalence of gastroesophageal reflux disease (GERD) in Western societies has accelerated the need for new modalities of treatment. Currently, medical and surgical therapies are widely accepted among patients and physicians. The minimally invasive treatment revolution, however, has stimulated several new endoscopic techniques for GERD. Up to now, the data is limited and further studies are necessary to compare the advantages and disadvantages of the various endoscopic techniques to medical and laparoscopic management of GERD. This systematic review reports the efficacy and durability of various endoscopic therapies for GERD whilst the potential for widespread use of these techniques is also discussed. Despite the limited number of studies and remarkable differences between various trials, strict criteria were used for the pooled data presented and an effort was made to avoid bias by including only studies that used off-antisecretory medication scoring as baseline and intent to treat.     

Endoscopic therapies for gastroesophageal reflux disease

Gastroesophageal reflux disease (GERD) accounts for a substantial degree of medical resource utilization and is a common indication for outpatient physician visits. The primary therapy for GERD has been proton pump inhibitors (PPIs). Equally effective and reasonably safe for GERD is surgical therapy, specifically, laparoscopic Nissen fundoplication. Medical therapy is used initially, with surgery reserved for patients with refractory symptoms despite optimal medical management, to avoid the added risks of abdominal surgery. As such, there has been considerable investigation into minimally invasive, endoscopic therapies for patients who respond to PPI, but would prefer to avoid long-term medication use. Here, we discuss the anatomical and physiological barriers that must be overcome by such devices. We further review the data on currently available endoscopic devices. Despite considerable interest and resources in developing an effective endoscopic therapy for GERD, none of the currently available technologies have demonstrated an ability to overcome the pathophysiological hurdles present in most patients with GERD. Furthermore, well-designed trials have not demonstrated adequate clinical efficacy for these endoscopic devices. As such, despite a growing need for an intermediate therapy between PPI and fundoplication, at present there is not adequate evidence to recommend endoscopic therapy for patients with GERD.     

Endoscopic therapy for gastroesophageal reflux disease

Endoscopic therapies aimed to reduce gastroesophageal reflux have gained an enormous enthusiasm during the last 5 years when several of them were approved by the regulatory agencies and released on the market. These novel therapies comprise 3 types of techniques: injection/bulking, plicating/suturing and radiofrequency thermal injury. Open-labelled trials performed on proton pump inhibitors-responding patients with typical gastroesophageal reflux disease (GERD) symptoms have shown an improvement in reflux symptoms during short term follow-up. Longer-term data are now available and show disappointing results with partial-thickness plications of the cardia. Randomized sham-controlled trials, which are essential to proof the efficacy of GERD endotherapy because of a known high placebo effect in the management of GERD patients, have been conducted, one with radiofrequency and one with polymer injection, and have confirmed the clinical efficacy of both techniques, although the clinical benefit was less impressive than suggested in open-labelled trials. While mechanistic studies have suggested that the compliance of the gastroesophageal junction might be altered by GERD endotherapy, objective assessment of acid reflux with ambulatory pH-metry has shown, however, minimal or no modification by the treatment. Concerns about the safety of these new techniques have raised when complications were reported as the number of treated cases increased. Currently, no definite indication is established for each technique, but numerous potential indications exist and should be addressed in the setting of carefully designed clinical trials. Physicians should be patient and wait for proof of efficacy and safety of these techniques before using them in their clinical practice. Specific and extensive warning should be obtained before starting clinical application. The present review aims to provide a comprehensive and critical view of endoscopic therapy in GERD management.     

Endoscopic therapies for the management of gastroesophageal reflux disease

Gastroesophageal reflux disease (GERD) is a common disorder with rising incidence worldwide and very high medical costs to society. The medical management of the disease i.e. lifestyle modifications and proton pump inhibitors reaches excellent results in most cases, but it needs to be continued, lifelong; the real cure of the disease is nowadays laparoscopic fundoplication, which is effective and safe in over 95% of well selected patients to provide a durable high quality of life. A very attractive alternative to these well established therapies is the endoscopic treatment of GERD, that employs different endoluminal technologic skills: plication of gastric cardia folds by suturing devices, radiofrequencies thermal-induced cardial fibrosis and bulking or sclerosing agents local injections have been recently tried and validated by different very experienced endoscopic groups. Although endoscopic therapy of GERD seems to be safe and feasible, a definite judgement awaits the results of multicentric controlled studies and longer periods of follow-up; for the present they must be restricted to well experienced endoscopists working to these controlled trials.     

Non-pharmacologic treatment strategies in gastroesophageal reflux disease

Abstract   In the West, gastroesophageal reflux disease (GERD) is a common and well-recognized disease. Lately, it has been described as an emerging problem in the East as well. While it is not a rapidly fatal illness, it causes a myriad of disturbing symptoms that remarkably reduce the patients' quality of life (QOL). The economic impact that results from multiple consultations, diagnostic investigations, and administration of a variety of treatment regimens, including surgery, is enormous.
The operative management for GERD is fundoplication, for example Toupet (270 degree wrap of the distal esophagus) and Nissen (360 degree wrap of the distal esophagus). These surgical procedures are aimed at permanently controlling acid reflux by reconstructing the gastroesophageal junction. Currently, the ease, aesthetic advantages, and the comparable outcomes achieved by minimally invasive laparoscopic fundoplication have rekindled interest in the operative alternatives of GERD management. Fundoplication controls or diminishes considerably the severity of the symptoms associated with GERD. However, appearance of new symptoms i.e. dysphagia, 'gas–bloat syndrome', etc. as postoperative events have been reported.
Recently, several innovative endoluminal treatment modalities have been introduced, namely; endoscopic plicator/suturing devices, bulking injections, and radiofrequency treatment. They are focused on enhancing the performance of a malfunctioning lower esophageal sphincter. While results of several case series reflect substantial improvements in GERD-HRQL scores, lack of long-term durability data is a major concern when recommending these novel, relatively simple, peroral techniques to a long suffering patient. It is clear that these therapies are still evolving and long-term outcomes of properly designed comparative efficacy trials are awaited.     

Therapeutic flexible endoscopy replacing surgery: Part 2—Gastroesophageal reflux disease and its complications

Gastroesophageal reflux disease (GERD) is a complex entity whereby gastric contents reflux into the esophagus owing to either a lack of a natural barrier between the stomach and esophagus or a dysfunction of foregut motility. In many cases, elements of both are present. GERD presents with either typical or atypical symptoms and can lead to metaplasia of the esophageal epithelium, a precancerous condition called Barrett's esophagus (BE). GERD is a chronic disease, and like other chronic diseases, it requires a thorough evaluation to deduce the exact etiology and also necessitates a dynamic and evolving spectrum of therapy. Until relatively recently, the spectrum of treatment for chronic GERD and BE included lifestyle modification, pharmacotherapy, and laparoscopic fundoplication. Considering the effect of chronic GERD on health and quality of life, and with further progress in understanding the disease process, newer and less invasive techniques for treatment have emerged and developed over the past decade. The 2 current FDA-approved therapies for the endolumenal treatment of GERD are transoral incisionless fundoplication with the Esophyx2 device and the Stretta system. If chronic GERD has lead to BE, endolumenal therapies include radiofrequency ablation with the HALO system or endoscopic resection of the metaplastic changes. Data regarding the outcomes of each of these procedures are accumulating rapidly; however, further data and evaluation are necessary to determine the most appropriate place for these procedures in the spectrum of therapy for chronic GERD and BE.     

Endoscopic Options for Gastroesophageal Reflux: Where Are We Now and What Does the Future Hold?

Early in the twenty-first century, novel endoscopic techniques were introduced for the management of gastroesophageal reflux disease, providing minimally invasive ways to eliminate pharmacologic acid inhibition and avoid the need for anti-reflux surgery. These techniques do not significantly alter the anatomy of the gastroesophageal junction, minimizing short- and long-term adverse effects, such as dysphagia and bloating. After extensive clinical testing, many endoscopic therapies were abandoned due to either lack of durable efficacy or unfavorable safety profile. Today, only four such therapies remain clinically available, each with variable levels of clinical validation and market penetration. This review will provide an assessment of these endoscopic therapies, highlighting their respective strengths and weaknesses and their present and future applicability to patients with gastroesophageal reflux disease.     

Endoscopic antireflux procedures: a good wrap?

BACKGROUND & AIMS: Gastroesophageal reflux disease (GERD) is prevalent worldwide. Until recently patients and physicians have had a choice between long-term medical therapy, usually in the form of proton pump inhibitors (PPIs), or surgical fundoplication. During the past several years, endoscopic antireflux therapies have been approved for GERD patients to potentially obviate the risks of surgery and avoid long-term medication use. The objective of this review was to critically evaluate existing literature on endoscopic antireflux therapies with regards to efficacy and safety. METHODS: A review of human studies by using Pub Med was performed. RESULTS: Injectable LES implants, endoscopically placed gastric plications, and radio frequency energy application to the LES comprise the 3 modes of antireflux therapies. These techniques received approval by the Food and Drug Administration on the basis of symptomatic evidence supplied by numerous uncontrolled trials. As a group, these techniques have demonstrated efficacy less than medical and surgical options, and yet they carry a rare but significant risk of serious complications and even death. CONCLUSIONS: The field is still evolving at this stage, and there is a need for more randomized sham and placebo-controlled trials to better define the subjective and objective outcomes of these endoscopic procedures. At this time endoscopic antireflux procedures should be used with caution after discussing risks and benefits with the patient.     

Endoscopic anti-reflux therapy for gastroesophageal reflux disease

Gastroesophageal reflux disease has an increasing incidence and prevalence worldwide. A significant proportion of patients have a suboptimal response to proton pump inhibitors or are unwilling to take lifelong medication due to concerns about long-term adverse effects. Endoscopic anti-reflux therapies offer a minimally invasive option for patients unwilling to undergo surgical treatment or take lifelong medication. The best candidates are those with a good response to proton pump inhibitors and without a significant sliding hiatal hernia. Transoral incisionless fundoplication and nonablative radiofrequency are the techniques with the largest body of evidence and that have been tested in several randomized clinical trials. Band-assisted ligation techniques, anti-reflux mucosectomy, anti-reflux mucosal ablation, and new plication devices have yielded promising results in recent noncontrolled studies. Nonetheless, the role of endoscopic procedures remains controversial due to limited long-term and comparative data, and no consensus exists in current clinical guidelines. This review provides an updated summary focused on the patient selection, technical details, clinical success, and safety of current and future endoscopic anti-reflux techniques.     

Endoscopic therapy for gastroesophageal reflux disease

Many new and developing endoscopic techniques for treatment of gastroesophageal reflux disease (GERD) are now or will soon be available for clinical use. These new therapies are directed to the gastroesophageal junction and include three basic techniques, which are outlined in this review: thermal remodeling and neurolysis of the lower esophageal sphincter (LES) zone; bulking or reinforcing of the LES; and plicating gastric folds at the gastric cardia. Only two of these treatments, radiofrequency ablation and fundic fold plication, have been approved by the US Food and Drug Administration (FDA). Published clinical research on endoscopic treatment is reviewed, although it is mostly comprised of open-label trials and anecdotal clinical reports. Complications of endoscopic GERD treatments are described as well as real and potential pitfalls of these techniques. Problems caused by premature introduction of endoscopic GERD treatments into the marketplace are also discussed, along with the rationale for FDA approval of similar devices.     

Endoscopic therapy for gastroesophageal reflux disease: a systematic review

Endoscopic therapy has emerged as an alternative for patients with symptomatic gastroesophageal reflux disease (GERD) who are seeking a non-pharmacologic, non-surgical intervention. To date, there are 3 basic categories of these endoscopic options: radiofrequency ablation, endoscopic suturing and endoscopic injection. Although the pivotal clinical studies to date have consistently demonstrated efficacy for defined endpoints of symptom control, GERD health related quality of life and discontinuance of acid secretory medications, depending on the therapy, there has been less consistent improvement in objective parameters of pH control and lower esophageal sphincter pressure. Although the data for these procedures has been favorable, extrapolation to justify a more widespread clinical use has been limited by the relative lack of controlled sham studies-although these are currently underway for all of the available therapies. Appropriate patient selection for endoscopic GERD therapy is critical and at present these therapies have the best clinical outcome data in patients who are responsive to therapy with a proton pump inhibitor. The risk/benefit profile, long term durability and cost effectiveness should be considered in all patients being considered when evaluating each of the endoscopic therapies for GERD.     

Enteryx implant for gastroesophageal reflux disease

Opinion statement Although pharmacologic therapy is safe and effective for gastroesophageal reflux disease (GERD), patients requiring chronic drug treatment often seek alternatives. Surgical alternatives to chronic drug treatment are associated with increased morbidity and long-term failure rates in more than 50% of surgically treated patients. Newer endoluminal therapies using modifications of standard endoscopy techniques are under evaluation as alternatives to chronic drug treatment or surgical intervention for GERD. Appropriate patient selection is KEY. Patients considered for any endoluminal therapy should have well documented GERD and demonstrated appropriate and successful response to medical therapy with a proton pump inhibitor (PPI). The Enteryx implant is an injectable biocompatible polymer approved by the US Food and Drug Administration for the management of GERD symptoms. Clinical trial data indicate that the Enteryx procedure is a safe and effective GERD treatment that manages symptoms of GERD and addresses the underlying anatomic and functional aspects of the disorder. Multicenter clinical trials have shown that the Enteryx procedure safely and effectively eliminates or significantly reduces PPI use in approximately 84% of patients at 1 year and 72% of patients at two years. The risk-benefit profile of this procedure and alternative treatment options should be carefully evaluated for each patient considered a candidate for Enteryx and all endoluminal therapies. Randomized-controlled studies comparing the Enteryx procedure to placebo and cost-effective analyses comparing treatment options will further define the use of the Enteryx implant in patients with GERD.     

Endoscopic techniques for treatment of gastroesophageal reflux disease: A review of abstracts from Digestive Disease Week 2003

Endoscopic treatments of gastroesophageal reflux disease (GERD) are a new and potentially useful form of therapy for reflux disorders. This type of treatment was first introduced at Digestive Disease Week (DDW) in 2000, and the most recent DDW, in 2003, included a growing number of abstracts describing further experience with endoscopic GERD treatments. The studies are still generally open-label trials involving relatively small patient groups given a variety of unique endoscopic GERD treatments, including radiofrequency, thermal ablation, plication suturing, and polymer injection and implantation techniques. Longer patient follow-up after Stretta (Curon Medical, Sunnyvale, CA) procedures, the permanency rate of EndoCinch (Bard Interventional Products, Billerica, MA) plication sutures, and new experiences with Enteryx (Boston Scientific, Natick, MA) and Gatekeeper (Medtronic, Minneapolis, MN) procedures were highlighted at DDW 2003. Despite these unique devices with significant potential for treatment of GERD, caution was expressed concerning their clinical use in anything other than appropriately designed, scientifically validated clinical trials.     

Long-term management of GERD. Why using endoscopy just now?

Early results with the use of endoscopic techniques in the treatment of gastro-oesophageal reflux disease (GERD) have been recently reported. Methods used are an injection of biocompatible substances within the lower oesophageal sphincter (LES), LES ablation using radio-frequency, and suture of folds in the area distal to the Z-line. The latter--endoscopic gastroplasty--is most difficult, but this technique has been most widely accepted by gastroenterologists to this date. Effectiveness of these endoscopic management systems in the long-term control of GERD has never been compared to a control group. This fact, together with the proven efficacy of anti-secretory drugs and the refinement of laparoscopic surgery during the past few years, has led physicians to be more demanding regarding early results. This review will discuss each method available, and issues answered by reported studies to this day are approached.     

Endoscopic and laparoscopic treatment of gastroesophageal reflux

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.     

Endoscopic treatment of gastro-oesophageal reflux disease (GORD): a systematic review

Gastro-oesophageal reflux disease represents an extremely common disorder which has a substantial impact on patients' quality of life and use of health care resources. Gastro-oesophageal reflux disease is a chronic relapsing disease for which a lifelong solution is needed. Until now the two competing therapeutic modalities have been the medical and surgical therapies. Quite recently a third option has become available. A number of endoscopic anti-reflux procedures have been described, with the common goal of creating an anti-reflux barrier, thus obviating long-term proton pump inhibitors and the cost and potential risk of laparoscopic Nissen fundoplication. In this review the different techniques are thoroughly examined and the results are critically evaluated, giving special emphasis to efficacy, safety and durability of these new anti-reflux procedures. Available data show that these anti-reflux techniques produce significant improvement in gastro-oesophageal reflux disease symptomatology and quality of life as well as reduce the use of anti-reflux medication, without causing serious morbidity or mortality. However, the majority of these techniques have failed to adequately control oesophageal acid reflux. Endoscopic anti-reflux therapies therefore sound very attractive-being less invasive than surgery-and show a significant promise, but are still in the early stages of assessment. Large-scale randomized multi-centre trials comparing control groups with sham procedures are essential to confirm their efficacy. Further studies are also necessary to determine what modifications these techniques require in order to produce maximum clinical efficacy and durability. However, considering that current therapies (both medical and surgical) of gastro-oesophageal reflux disease are highly effective, the need for such new endoscopic modalities may be questionable. Moreover, appropriate trials in dedicated centres should be carried out to assure that the enthusiasm commonly associated with new technology is justified and can be generalized to open-access endoscopists.     

GERD: the potential for endoscopic intervention

Gastroesophageal reflux disease (GERD) is a common disorder that significantly affects patients' quality of life. Most patients with symptomatic GERD do not have erosive reflux disease. Frequent transient lower oesophageal sphincter relaxations and the presence of hiatal hernia have emerged as major and interacting factors in GERD. Several endoscopic anti-reflux therapies aiming at creating an anti-reflux barrier and reducing or eliminating the need for chronic medical therapy or fundoplication have been introduced and validated as feasible, safe and effective. Today, it is possible to manage GERD patients with a multioption approach of medical, endoscopic or surgical therapies according to the size of hiatal hernia, the lower esophageal pressure profile and their clinical response to single-modality therapy.     

Treatment of GERD complications (Barrett's, peptic stricture) and extra-oesophageal syndromes

Apart from typical reflux symptoms and oesophagitis, the clinical presentation of GERD can be dominated by mucosal complications of reflux (Barrett's oesophagus, oesophageal adenocarcinoma, Peptic structure) or by extra-oesophageal syndromes, most notably asthma, laryngitis, or chronic cough. Managing these entities is much less straightforward than with oesophagitis. With respect to adenocarcinoma, metaplasia and dysplasia are recognised precursors, but the potential of these lesions to evolve to cancer has not been shown to lessen as a result of treatment, medical or surgical. Consequently, management focuses on strategies to identify and eliminate high-grade dysplasia and intramucosal cancer, lesions that are potentially curable by endoscopic ablation or surgical resection. With respect to the extra-oesophageal GERD syndromes, these are increasingly recognised as multifactorial conditions with reflux as an exacerbating factor. Treatment trials have been generally disappointing and the clinical challenge remains in accurately identifying afflicted patients who might benefit from more intensive medical or surgical reflux treatment.     

Gastrooesophageal reflux disease

Gastrooesophageal reflux disease, GERD, is a common problem which is expensive to diagnose and treat. The disease is increasing in prevalence in the Western world with important risk factors being obesity and the eradication of Helicobacter pylori. Increasing research points to transient LES relaxation and spatial separation of the diaphragm and LES (hiatal hernia in chest) being the critical mechanisms of acid reflux. Heartburn and acid regurgitation are classic symptoms of GERD, but their sensitivity is poor. Ambulatory oesophageal pH testing is the most sensitive test for GERD, while endoscopy is the most specific test. Medical treatment with PPIs has revolutionized the treatment of GERD and its complications, but long-term side effects do exist. Laparoscopic antireflux surgery and PPIs have similar efficacy in the few available long-term trials. Currently, endoscopic treatments for GERD should not be a clinical alternative outside of research trials. New drug therapies should be directed at modulating transient LES relaxation.