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SSAT Patient Care Guidelines

Endotherapy of GERD

Introduction
Gastroesophageal reflux disease (GERD) occurs when gastric or duodenal contents back up (reflux) into the esophagus. About 10% of adult Americans have daily symptoms of ‘heartburn’. Repeated episodes of reflux can damage the esophageal epithelium, leading to esophagitis. A small proportion of patients progress to severe esophagitis. In most cases, the underlying cause of reflux is a defective lower esophageal sphincter. The risk of GERD is higher in patients with a hiatal hernia and its symptoms can usually be controlled with medical therapy directed at buffering or suppressing secretion of gastric acid.

Symptoms
GERD can usually be diagnosed by a careful history. Gastroesophageal reflux typically results in a substernal burning discomfort or ‘heartburn’, which is often relieved by antacids. Some patients may also experience esophageal spasm with a squeezing chest pain that is often confused with angina. Refluxed material can be aspirated into the larynx causing hoarseness, or into the tracheobronchial tree causing wheezing and coughing. Dysphagia may occur as a complication of chronic reflux.

Diagnosis
The diagnosis of GERD and the determination of the extent of damage to the esophageal epithelium may require a series of investigations. The mainstay of diagnosis is flexible esophagoscopy, by which demonstration of mucosal erosion or ulceration is evidence of reflux damage. Endoscopy is also essential to make the pathologic diagnosis of Barrett's metaplasia. Barium esophagography is a useful diagnostic test to evaluate for hiatal hernia, strictures, and esophageal shortening. Esophageal manometry is an important pre operative study to evaluate lower esophageal sphincter function and peristaltic activity in the body of the esophagus. Impaired motor activity in the esophagus should influence the choice of surgical procedure. Ambulatory 24-48 hour pH monitoring can document reflux episodes by indicating a drop in esophageal pH to acidic levels (less than 4.0). It is best to perform pH testing while off all antisecretory medications. Before such testing, it is preferable to stop proton pump inhibitors (PPI) for 7-14 days and H2 antagonists for 72 hours.

Treatment
Patients with typical gastroesophageal reflux symptoms should initially be managed by lifestyle modifications. Foods and beverages that can relax the lower esophageal sphincter should be avoided, including chocolate, peppermint, fatty foods, coffee, and alcoholic beverages. Also to be avoided are foods and beverages that can irritate an inflamed esophageal mucosa, such as citrus fruits and juices, tomato products, and pepper. Elevation of the head and torso while sleeping, not lying down immediately after meals and abstinence from smoking are also helpful. Medical therapy, including antacids, H2 receptor blocking drugs, and PPI, is directed at reducing the acid content of refluxed material. Acid inhibition is most effectively achieved with PPI. Promotility drugs (including metoclopramide and domperidone) are of little benefit in patients with severe reflux symptoms, unless they have delayed gastric emptying. Although medical therapy is highly effective in controlling the signs and symptoms of gastroesophageal reflux, approximately 80% of patients will relapse within three months if therapy is discontinued, and up to 50% will require escalating doses of PPI.

What is Endotherapy?
Endotherapy is being investigated and developed as a less invasive alternative to laparoscopic and open anti-reflux surgery. These techniques can be performed in an outpatient setting. Generally, they are considered for patients who are failing maximal medical therapy. Endotherapy can be classified into one of three categories. The first is the ‘synthetic implants/injections’ and these are no longer performed because of safety concerns. The second is the ‘radiofrequency energy delivery device’ or Stretta procedure. And the third is the ‘endoscopic suturing devices’ (endoluminal gastroplication, endoluminal full thickness plicator, and Syntheon ARD plicator). All of these procedures are performed endoscopically, and do not involve an incision. The proposed mechanisms of action for endotherapy procedures include an increase in the lower esophageal pressure, a decrease in the compliance of the gastroesophageal junction, and a decrease in the frequency of transient lower esophageal sphincter relaxations.

Who are Candidates for Endotherapy?
Patients who have frequent symptoms of regurgitation, have at least a partial response to PPI, have unsatisfactory control of GERD despite escalated doses of PPI, and have confirmed GERD on 24 pH monitoring are candidates for endotherapy of GERD. Patients are not appropriate for endotherapy if they are <18 years old or have: esophageal varices, Barrett’s esophagus, severe esophagitis (grade C or higher), hiatus hernia > 2cm, esophageal dysmotility, or the presence of dysphagia.

Limitations and Unanswered Questions
Most studies of endoscopic therapy have limited follow-up of a small number of patients. To date there are limited data regarding the mechanism of action of these procedures. There are few trials that have rigorously examined meaningful outcomes. There are very few data regarding short and long term safety, long term efficacy, applicability to various subgroups of GERD patients, their value when used in combination with other therapies (PPI, surgery), as well as cost effectiveness.

Current Recommended Use
There is a need for randomized controlled trials of sufficient size to understand the true effectiveness of all of the endoscopic therapies for GERD, and to demonstrate long term durability. Current data suggest that there are no definite indications for endoscopic therapy of GERD at this time. Physicians and patients considering endotherapy of GERD need to be aware of the limitations of the data currently, and should consider endotherapy only within the confines of a well designed clinical trial.

Qualifications for Performing Endoscopic Therapy for Gastroesophageal Reflux
The qualifications of a surgeon or gastroenterologist performing any endotherapy procedure should be based on training (education), experience, and outcomes. Antireflux endotherapy should preferably be performed by surgeons or gastroenterologists with special knowledge, training and experience in the management of gastroesophageal disease within the context of a well designed clinical trial that is designed to study long term efficacy.

Suggested Readings

  1. Falk GW, Fennerty MB, Rothstein RI. AGA Institute technical review on the use of endoscopic therapy for gastroesophageal reflux disease. Gastroenterology. 2006;131:1315–1336.
  2. Corley DA, Katz P, Wo J, et al. Improvement of gastroesophageal reflux symptoms after radiofrequency energy: a randomized, sham-controlled trial. Gastroenterology. 2003;125:668–676.
  3. Triadafilopoulos G. Endotherapy and surgery for GERD. J Clin Gastroenterol. 2007 Jul;41(6 Suppl 2):S87-96.
  4. Sgouros SN, Bergele C. Endoscopic therapy for gastroesophageal reflux disease: a systematic review. Digestion. 2006;74(1):1-14.
  5. Williams DB, Richards WO. Endoluminal therapy for GERD: Where we stand. Contemp Surg. 2008;64:170-176.

KeyWords - patient, guideline, endotherapy, heartburn, gastroesophageal reflux, deglutition disorders, regurgitation.

Board Approved 05/30/09

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Disclaimer
SSAT Patient Care Committee Guidelines

These patient care guidelines were written for the primary care physicians on a variety of digestive diseases to assist on when to refer the patient for surgical consultation.
Their goal is to guide PRIMARY CARE physicians to the appropriate utilization of surgical procedures on the alimentary tract or related organs and they are based on critical review of the literature and expert opinion. Both of the latter sources of information result in a consensus that is recorded in the form of these Guidelines. The consensus addressses the range of acceptable clinical practice and should not be construed as a standard of care. These Guidelines require periodic revision to ensure that clinicians utilize procedures appropriately but the reader must realize that clinical judgment may justify a course of action outside of the recommendations contained herein.

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