Role of endoscopy in the management of GERD

Transcription

1 GUIDELINE Role of endoscopy in the management of GERD This is one of a series of statements discussing the use of gastrointestinal endoscopy in common clinical situations. The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy prepared this text. In preparing this guideline, a search of the medical literature was performed using PubMed, supplemented by accessing the related articles feature of PubMed. Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When little or no data exist from well-designed prospective trials, emphasis is given to results from large series and reports from recognized experts. Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time the guidelines are drafted. Further controlled clinical studies may be needed to clarify aspects of this guideline. This guideline may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice. The recommendations were based on reviewed studies and were graded on the strength of the supporting evidence (Table 1). 1 This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients. This guideline is not a rule and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. Clinical decisions in any particular case involve a complex analysis of the patient s condition and available courses of action. Therefore, clinical considerations may lead an endoscopist to take a course of action that varies from these guidelines. This guideline supplements and replaces our previous document on the role of endoscopy in GERD. 2 Gastroesophageal reflux disease (GERD) is a condition that develops when reflux of stomach contents causes troublesome symptoms (eg, heartburn and regurgitation) or complications (eg, erosive esophagitis). 3-5 In a recent systematic review, the prevalence of GERD in the Western world was estimated to be 10% to 20%, with GERD defined as at least weekly heartburn and/or acid regurgitation. 3,4 GERD is the third most common GI disorder in Copyright ª 2007 by the American Society for Gastrointestinal Endoscopy /$32.00 doi: /j.gie the United States, affecting 19 million adults and accounting for 4,590,000 outpatient visits and 96,000 hospitalizations annually. 6 The annual economic impact of GERD was estimated to be $9.3 billion in Greater than 60% of this burden is related to the cost of antisecretory medications. 8 In addition to quality of life issues, the numerous complications of chronic GERD, such as esophageal stricture formation, Barrett s metaplasia, and esophageal adenocarcinoma, necessitate adequate diagnosis and treatment of this common entity. INDICATIONS FOR ENDOSCOPIC EVALUATION A diagnosis of GERD can be made based on a history of classic symptoms 3 and favorable response to antisecretory medical therapy. 2,3 It is important to note that epigastric pain can be the major symptom of GERD. 3 If the patient s history is typical for uncomplicated GERD, an initial trial of empiric medical therapy is appropriate prior to endoscopy in most patients. 9 Endoscopy at presentation should be considered in patients who have symptoms suggestive of complicated disease or those at risk for Barrett s esophagus Failure to respond to appropriate antisecretory medical therapy or the presence of other clinical signs suggestive of complicated GERD should prompt evaluation with EGD and consideration of other diagnostic modalities, including ambulatory ph monitoring, esophageal manometry, and multichannel impedance testing. 13 The indications for EGD in patients with GERD are listed in Table 2. Endoscopy should also be considered in the evaluation and management of patients with suspected extra-esophageal manifestations of GERD who present with symptoms such as choking, coughing, and hoarseness. 14 Additionally, EGD may be necessary for the detection or exclusion of erosive esophagitis, peptic strictures, esophageal cancer, gastric outlet obstruction, and other potentially significant upper-gi tract findings. It has been proposed that a baseline EGD should be performed in patients with GERD requiring continuous acid-suppressive therapy, especially after recurrence of symptoms upon withdrawal of successful medical therapy. 15 Such a recommendation is not universally accepted, however, and one must also consider associated drawbacks of EGD, such as the potential physical risks, financial costs, and limited access to the procedure. There is also a paucity of outcomes research to suggest that early Volume 66, No. 2 : 2007 GASTROINTESTINAL ENDOSCOPY 219

2 TABLE 1. Grades of recommendation Grade of recommendation Clarity of benefit Methodologic strength/ supporting evidence Implications 1A Clear Randomized trials without important limitations 1B Clear Randomized trials with important limitations (inconsistent results, nonfatal methodologic flaws) 1Cþ Clear Overwhelming evidence from observational studies Strong recommendation; can be applied to most clinical settings Strong recommendation; likely to apply to most practice settings Strong recommendation; can apply to most practice settings in most situations 1C Clear Observational studies Intermediate-strength recommendation; may change when stronger evidence is available 2A Unclear Randomized trials without important limitations 2B Unclear Randomized trials with important limitations (inconsistent results, nonfatal methodologic flaws) Intermediate-strength recommendation; best action may differ depending on circumstances or patients or societal values Weak recommendation; alternative approaches may be better under some circumstances 2C Unclear Observational studies Very weak recommendation; alternative approaches likely to be better under some circumstances 3 Unclear Expert opinion only Weak recommendation; likely to change as data become available Adapted from Guyatt G, Sinclair J, Cook D, et al. Moving from evidence to action: grading recommendationsda qualitative approach. In: Guyatt G, Rennie D, editors. Users guides to the medical literature. Chicago: AMA Press; p TABLE 2. Indications for endoscopy in patients with GERD GERD symptoms that are persistent or progressive despite appropriate medical therapy Dysphagia or odynophagia Involuntary weight loss O5% Evidence of GI bleeding or anemia Finding of a mass, stricture, or ulcer on imaging studies Evaluation of patients with suspected extra-esophageal manifestations of GERD Screening for BE in selected patients (as clinically indicated) Persistent vomiting Evaluation of patients with recurrent symptoms after endoscopic or surgical antireflux procedures or even once-in-a-lifetime EGD has a favorable effect upon the management, course, or health-related quality of life of patients with typical symptoms of GERD without alarm features. 4 Endoscopy is often performed as part of the preoperative evaluation of patients being considered for antireflux surgery, for the placement of a wireless esophageal ph monitoring system (as described in a recent technology status evaluation report), and is an inherent part of various endoscopic antireflux procedures. 16 DIAGNOSIS AND CLASSIFICATION OF GERD Patients with reflux esophagitis have endoscopic and/or histopathologic changes of esophageal mucosal injury and inflammation. The presence of typical findings of reflux esophagitis on endoscopy is diagnostic of GERD with a specificity of 90% to 95%. 17,18 At least 50% of patients with reflux symptoms have normal esophageal endoscopic findings (nonerosive reflux disease [NERD]) or uncomplicated GERD. 3,19 Furthermore, GERD symptoms do not correlate with the degree of underlying esophageal damage. Because of these observations, current recommendations are to initiate empiric antisecretory therapy in patients with typical GERD symptoms in the absence of alarm features GASTROINTESTINAL ENDOSCOPY Volume 66, No. 2 :

3 TABLE 3. The modified Los Angeles classification of GERD TABLE 4. The modified Savary-Miller classification of GERD Grade Description Grade Lesion A B C D One (or more) mucosal break no longer than 5 mm that does not extend between the tops of 2 mucosal folds One (or more) mucosal break more than 5 mm that does not extend between the tops of 2 mucosal folds One (or more) mucosal break that is continuous between the tops of 2 or more mucosal folds but that involves less than 75% of the circumference One (or more) mucosal break that involves at least 75% of the esophageal circumference I II III IV V Single or isolated erosive lesion, oval or linear, but affecting only 1 longitudinal fold Multiple erosive lesions, noncircumferential, affecting more than 1 longitudinal fold, with or without confluence Circumferential erosive lesions Chronic lesions including ulcer(s), stricture(s), and/or short esophagus, alone or associated with lesions of grades I to III Columnar epithelium in continuity with the Z line, noncircular, star-shaped, or circumferential, alone or associated with lesions grades I to IV There are several classification systems for grading the endoscopic severity of erosive reflux esophagitis and associated complications 20 (Tables 3 and 4). These classification systems have been primarily used in clinical trials to study the efficacy of medical therapy as treatment of reflux esophagitis. However, these systems are useful in clinical practice for documenting disease severity. Currently, the most commonly used systems are the Los Angeles classification (Table 3) and the Savary-Miller classification (Table 4), with the latter being used predominantly in Europe. The Los Angeles classification has several advantages. First, it has been shown to be reliable, with good intra- and inter-observer agreement when tested among expert and inexperienced endoscopists. 20 Second, when using this system, the severity of esophagitis has been demonstrated to correlate with the extent of esophageal acid exposure determined by 24-hour ph monitoring. 21 These 2 systems avoid the use of erythema as a descriptor due to its nonspecific language. It is strongly recommended that the endoscopist describe the extent of endoscopic abnormalities, either through the use of an accepted grading system or by a detailed description of the endoscopic findings. When esophagitis is defined endoscopically, biopsy specimens of the mucosa should be obtained under the following circumstances: underlying immunocompromised state, irregular or deep ulceration present, proximal distribution of esophagitis, presence of a mass lesion or nodularity, an irregular or malignant-appearing stricture. In these situations, forceps biopsy and/or brush cytology specimens are necessary to exclude other diagnoses, including infectious etiologies and malignancy. Historically, follow-up EGD for patients with GERD with esophagitis was reserved for patients whose symptoms failed to respond to medical therapy, those who had severe esophagitis or an esophageal ulcer, or for those who needed additional biopsy to clarify a diagnosis. It has recently been suggested, however, that there may be a role for repeat EGD after adequate medical therapy has achieved mucosal healing in patients with esophagitis, specifically to exclude Barrett s esophagus (BE). 22 COMPLICATIONS OF GERD Peptic strictures The endoscopic evaluation and management of peptic strictures is discussed in another guideline. 23 BE BE is a condition in which the squamous epithelium of the distal esophagus is replaced by an abnormal columnar epithelium known as specialized intestinal metaplasia. 24 BE can be found in 10% to 15% of patients undergoing EGD for GERD. 25 Recommendations outlining the role of EGD for screening and surveillance for BE have recently been published, 26 and the practice of screening and surveillance of BE remains a contentious issue. A landmark modeling study showed that a strategy of endoscopic screening for BE in 50-year-old white males with GERD followed by subsequent endoscopic surveillance for those with dysplasia was associated with acceptable costs per quality-adjusted life year saved. 27 Several other modeling studies reached similar conclusions regarding screening for this specific population but differed regarding the cost effectiveness of additional surveillance in patients with nondysplastic BE. 28,29 Widespread screening of the entire population with GERD would not be feasible given both the high prevalence of GERD in the Western world and the presence of many asymptomatic individuals harboring BE. 28 However, there appear to be factors associated with BE that may allow for the selection of Volume 66, No. 2 : 2007 GASTROINTESTINAL ENDOSCOPY 221

4 individuals for screening EGD, including a prolonged history of GERD symptoms (O5 years), white race, male sex, older age (O50 years), and family history of BE and/or adenocarcinoma of the esophagus. 25,26 Endoscopy is the most accurate tool for the detection and diagnosis of BE. In order to determine the presence of BE endoscopically, the squamocolumnar junction and the gastroesophageal junction must be clearly identified. While proximal displacement of the squamocolumnar junction relative to the gastroesophageal junction is suggestive of BE, this endoscopic appearance of salmoncolored mucosa or an irregular Z line, either alone or in combination, is not sufficient to make the diagnosis. 3 Biopsy specimens should always be obtained for histopathologic confirmation of columnar epithelium. The optimal number of biopsies necessary to identify intestinal metaplasia is not known, but it is generally accepted that multiple biopsy specimens should be obtained in all areas of suspected BE. 30 The presence of erosive esophagitis may impair the accurate histopathologic detection of Barrett s epithelium and dysplasia. 22 Multiple trials have demonstrated that an 8-week treatment duration is adequate to achieve mucosal healing in most patients with erosive esophagitis treated with proton-pump inhibitors (PPIs) A recently published trial involving 172 patients with esophagitis who did not have BE identified on initial EGD noted that, after therapy with PPIs (mean 11 weeks; range 8-16 weeks), BE was identified in 12%. 22 Recommendations from this trial included pretreatment with acid suppressive agents for patients with GERD symptoms who were undergoing EGD for BE screening, and consideration of repeat endoscopy after healing for those patients with esophagitis on index endoscopy. Care should be taken to avoid obtaining biopsy specimens from a normal-appearing squamocolumnar junction or from the proximal cardia because biopsy specimens from these areas may demonstrate intestinal metaplasia, which can be present at these locations and provide a false diagnosis of BE. 35,36 The finding of intestinal metaplasia of the gastroesophageal junction or cardia does not appear to confer the same (if any) malignant potential as does long-segment (R 3cm) BE, and there is no current evidence to support surveillance endoscopic examinations in these patients. 3,27,37 In patients with BE with no evidence of dysplasia on initial endoscopy, a repeat endoscopy should be performed within the next year. If no dysplasia is confirmed, these patients are considered to be at low risk to have their condition progress and/or develop cancer. Therefore, the interval for additional surveillance has been recommended to be every 3 years. However, on the basis of decision analysis models, the more appropriate interval may be 5 years. 26 Reassessment of the cost effectiveness of screening and surveillance for BE will need to be performed if new technologies, such as unsedated endoscopy with small-caliber endoscopesdpreviously shown to be reliable for screening for BE 38 and to prevent loss of work days 39 dand/or wireless capsule endoscopy (WCE), prove to be as accurate as standard EGD and biopsy for the diagnosis of BE and dysplasia. The precise role of these technologies for diagnosing or managing Barrett s epithelium, however, remains unclear at this time. 40 ENDOSCOPIC ANTIREFLUX PROCEDURES The endoluminal treatment of GERD is evolving and may have the potential to decrease the need for long-term antisecretory medications in selected patients. Most studies of endoluminal therapies for GERD have involved small numbers of PPI-dependent patients and have provided relatively limited follow-up information, so the durability of these therapies remains in question. Additionally, both shortand long-term safety issues surrounding the endoluminal devices continue to be a concern, and the economics of their use are unknown. A technical review on the use of endoscopic therapies for GERD was recently published. 41 The new endoscopic antireflux techniques represent a rapidly evolving area of GI endoscopy, but additional research is needed before they can be widely recommended. Appropriate patient selection and endoscopist experience should be carefully considered before pursuing these therapies. It is important that patients and practitioners alike be aware of the limitations in the evidence that exist with these devices at the present time. SUMMARY d GERD can be diagnosed on the basis of typical symptoms without the need for diagnostic testing, including endoscopy (1C). d In patients with uncomplicated GERD, an initial trial of empiric medical therapy is appropriate (1C). d Endoscopy is recommended for patients who have symptoms suggesting complicated GERD or alarm symptoms (2A). d Endoscopic findings of reflux esophagitis should be classified according to an accepted grading scale or described in detail (3). d Endoscopy should be considered in patients at risk for BE (2C). d Biopsy must be performed to confirm endoscopicallysuspected BE (2B). d Endoscopic biopsy specimens should not be obtained from an endoscopically normal tissue to exclude BE (2B). d For patients with established BE of any length and with no dysplasia, after 2 consecutive examinations within 1 year, an acceptable interval for additional surveillance is every 3 years (3). d Endoscopic antireflux therapy may be considered for selected patients with uncomplicated GERD after 222 GASTROINTESTINAL ENDOSCOPY Volume 66, No. 2 :

5 careful discussion with the patient regarding potential side effects, benefits, and other available therapeutic options (3). REFERENCES 1. Guyatt G, Sinclair J, Cook D, et al. Moving from evidence to action: grading recommendationsda qualitative approach. In: Guyatt G, Rennie D, editors. Users guides to the medical literature. Chicago: AMA Press; p American Society for Gastrointestinal Endoscopy. The role of endoscopy in the management of GERD: guidelines for clinical application. Gastrointest Endosc 1999;49: Vakil N, van Zanten SV, Kahrilas P, et al. The Montreal definition and classification of gastroesophageal reflux disease: a global evidencebased consensus. Am J Gastroenterol 2006;101: DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol 2005;100: Jones R, Galmiche JP. Review: what do we mean by GERD? Definition and diagnosis. Aliment Pharmacol Ther 2005;22(Suppl. 1): Russo MW, Wei JT, Thiny MT, et al. 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Clinical impact of upper endoscopy in the management of patients with gastroesophageal reflux disease. Am J Gastroenterol 2004;99: Lieberman DA, Oehlke M, Helfand M. Risk factors for Barrett s esophagus in community-based practice. GORGE consortium. Gastroenterology Outcomes Research Group in Endoscopy. Am J Gastroenterol 1997;92: Fock KM, Talley N, Hunt R, et al. Report of the Asia-Pacific consensus on the management of gastroesophageal reflux disease. J Gastroenterol Hepatol 2004;19: Poelmans J, Feenstra L, Demedts I, et al. The yield of upper gastrointestinal endoscopy in patients with suspected reflux-related chronic ear, nose, and throat symptoms. Am J Gastroenterol 2004;99: Dent J, Brun J, Fendrick A, et al. An evidence-based appraisal of reflux disease management the Genval Workshop Report. Gut 1999; 44(Suppl 2):S Chotiprashidi P, Liu J, Carpenter S, et al. Wireless esophageal ph monitoring system. Gastrointest Endosc 2005;62: Moayyedi P, Talley N. Gastro-oesophageal reflux disease. Lancet 2006; 367: Richter JE. Diagnostic tests for gastroesophageal reflux disease. Am J Med Sci 2003;326: Ronkainen J, Aro P, Storskrubb T, et al. High prevalence of gastroesophageal reflux symptoms and esophagitis with or without symptoms in the general adult Swedish population. A Kalixanda study report. Scand J Gastroenterol 2005;40: Rath HC, Timmer A, Kunkel C, et al. Comparison of interobserver agreement for different scoring systems for reflux esophagitis; impact of level of experience. Gastrointest Endosc 2004;60: Kahrilas PJ, Pandolfino JE. Review article: oesophageal ph monitoringtechnologies, interpretation, and correlation with clinical outcomes. Aliment Pharmacol Ther 2005;22(Suppl 3): Hanna S, Rastogi A, Weston AP, et al. Detection of Barrett s esophagus after endoscopic healing of erosive esophagitis. Am J Gastroenterol 2006;101: Egan JV, Baron TH, Adler DG, et al. Esophageal dilation. Gastrointest Endosc 2006;63: Spechler SJ. 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A critical review of the diagnosis and management of Barrett s esophagus: the AGA Chicago Workshop. Gastroenterology 2004;127: Castell DO, Kahrilas PJ, Richter JE, et al. Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. Am J Gastroenterol 2002;97: Kahrilas PJ, Pandolfino JE. Review article: oesophageal ph monitoringtechnologies, interpretation and correlation with clinical outcomes. Aliment Pharmacol Ther 2000;14: Labenz J, Armstrong D, Lauritsen K, et al. Esomeprazole 20 mg vs. pantoprazole 20 mg for maintenance therapy of healed erosive oesophagitis: results from the EXPO study. Aliment Pharmacol Ther 2005;21: Richter JE, Kahrilas PJ, Sontag SJ, et al. Comparing lansoprazole and omeprazole in onset of heartburn relief: results of a randomized, controlled trial in erosive esophagitis patients. Am J Gastroenterol 2001; 96: Spechler SJ, Zeroogian JM, Antonioli DA, et al. Prevalence of metaplasia at the gastro-oesophageal junction. Lancet 1994;344: Hirota WK, Loughney TM, Lazas DJ, et al. Specialized intestinal metaplasia, dysplasia, and cancer of the esophagus and esophagogastric junction: prevalence and clinical data. Gastroenterology 1999;116: Morales TG, Camargo E, Bhattacharyya A, et al. Long-term follow-up of intestinal metaplasia of the gastric cardia. Am J Gastroenterol 2000;95: Jobe BA, Hunter JG, Chang EY, et al. Office-based unsedated small-caliber endoscopy is equivalent to conventional sedated endoscopy in screening and surveillance for Barrett s esophagus: a randomized and blinded comparison. Am J Gastroenterol 2006;101: Nietert PJ, Silverstein MD, Mokhashi MS, et al. Cost-effectiveness of screening a population with chronic gastroesophageal reflux. Gastrointest Endosc 2003;57: Mishkin DS, Chuttani R, Croffie J, et al. Wireless capsule endoscopy. Gastrointest Endosc 2006;63: Falk G, Fennerty MB, Rothstein RI. AGA institute technical review on the use of endoscopic therapy for gastroesophageal reflux disease. Gastroenterology 2006;131: Volume 66, No. 2 : 2007 GASTROINTESTINAL ENDOSCOPY 223

6 Prepared by: STANDARDS OF PRACTICE COMMITTEE David R. Lichtenstein, MD Brooks D. Cash, MD Raquel Davila, MD Todd H. Baron, MD, Chair Douglas G. Adler, MD Michelle A. Anderson, MD Jason A. Dominitz, MD, MHS Seng-Ian Gan, MD M. Edwyn Harrison III, MD Steven O. Ikenberry, MD Waqar A. Qureshi, MD Elizabeth Rajan, MD Bo Shen, MD Marc J. Zuckerman, MD Robert D. Fanelli, MD, SAGES Representative Trina VanGuilder, RN, BSN, SGNA Representative This document is a product of the Standards of Practice Committee. This document was reviewed and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy. 224 GASTROINTESTINAL ENDOSCOPY Volume 66, No. 2 :