2024 ASGE指南：胃食管反流病的诊断和管理（概要和建议）

指南消化内科· 胃肠疾病 · 2024

OTHER CONSIDERATIONS Endoscopic therapies in pediatric patients

A literature search was performed to evaluate the current use of endoscopic antireflux therapies in pediatric patients. 2] [103] [104] Two studies 101, 102 reported the use of TIF, and 2 102, 103 examined Stretta for pediatric patients. These small studies demonstrate that Stretta can be used in pediatric patients. TIF seemed to demonstrate improved results in children, with 10 of 11 patients in 1 study having resolution of GERD 101 and 8 of 10 patients in another study 102 able to discontinue PPIs.

The pediatrics population has a wide age range, and the size of the scope with the device could pose a significant challenge and adverse events. Therefore, endoscopic antireflux therapies should currently only be performed in pediatric patients in the setting of a well-designed research study.

Novel GERD therapies

We performed a systematic review of studies comparing emerging and novel antireflux endoscopic interventions with medical therapy and/or sham interventions among adult (age 18 years) patients with chronic GERD. The novel and/or emerging interventions in this field include EMR (using band ligation or other forms of resection with or without plication), endoscopic mucosal ablation (using hybrid argon plasma coagulation or similar), an ultrasonic surgical endostapler device (MUSE; Medigus, Omer, Israel), and plication-based therapies including GERDx (G-SURG GmbH, Seeon-Seebruck, Germany). We also excluded interventions if the technology was out of date, not available, or has not been examined as a part of a clinical trial.

Our systematic review identified 1 RCT 105 and 1 prospective cohort study 106 examining endoscopic full-thickness fundoplication using a novel GERDx device, 7 prospective cohort noncomparative studies of the MUSE device, [107] [108] [109] [110] [111] [112] [113] 1 meta-analysis examining 10 noncontrolled cohort studies of antireflux mucosectomy, 114 1 nonrandomized comparative study for clip-band ligation antireflux therapy, 115 1 comparative trial of band ligation alone, 116 3 noncontrolled cohort studies of the resection and plication method, [117] [118] [119] and 1 meta-analysis examining 3 nonrandomized studies of antireflux mucosal ablation [120] [121] [122] as an antireflux intervention among patients with chronic GERD. We also found an RCT examining antireflux mucosectomy (clinical trials identifier: NCT04194723) and 2 RCTs examining antireflux mucosal ablation (clinical trials identifier: NCT04711655 and NCT05570448) that are underway.

Overall, short-term follow-up among these studies demonstrated improvement in GERD symptoms or related scores with a minimal adverse event profile. Similar to TIF 2.0, these strategies are primarily used for patients with chronic objectively confirmed GERD with small hiatal hernias. Robust data demonstrating a durable benefit of any 1 of these compared with standard medical therapy are lacking. We did not find any of these technologies being compared with TIF 2.0 in an RCT design. The panel recognized the promise of these emerging technologies that may become more prevalent as more data become available.

FUTURE DIRECTIONS

This guideline and literature review highlighted several areas in need of more data to guide decision-making for managing chronic GERD. Future studies should address the following: 1. Long-term benefit: Existing medical, endoscopic, and surgical therapies, despite a large body of evidence, do not have established evidence for long-term ( > 10 years) benefit. Previous studies of endoscopic antireflux therapies have demonstrated short-term benefit for a subset of patients. Future studies should examine long-term outcomes from endoscopic antireflux therapies including subjective and objective improvement in GERD with cessation of long-term PPI use. Similarly, these therapies need to be examined in comparison with medication adjustment and surgical therapies for best outcomes. Development of better endoscopic therapies that provide durable alteration of the antireflux barrier without need for surgery is required. 2. Objective improvement in GERD: A large body of data on endoscopic antireflux therapies report subjective improvement in GERD; however, they lack consistent reporting of improvement in objective parameters of GERD including acid exposure time. Because of this, reliability and repeatability of these interventions remain a concern. Future studies should incorporate and examine objective improvements in GERD in addition to reliance on patient-reported outcomes, which could be subjective. 3. Atypical GERD: Data on the benefit of medical therapy for atypical GERD symptoms are not robust. Improvement of atypical GERD symptoms (cough, reflux laryngitis, sore throat, asthma, throat clearing) should also be assessed in endoscopic antireflux therapies in a well-defined cohort. Additionally, existing therapies need to be examined for special populations where options are limited (ie, after SG, after POEM, scleroderma patients, etc). 4. Incidence of GERD after POEM: Varying rates and evolving techniques have been reported over the years, making a precise assessment difficult. Recent studies report a low incidence of severe persistent esophagitis after POEM. 23 It is unclear if there is an increased or decreased risk of BE and related esophageal cancer after POEM (ie, squamous cell and adenocarcinoma). Further studies are needed to better quantify these trends.

WHAT IS NEW

These guidelines highlight data suggesting that upper endoscopy should be performed among patients with a history of SG to screen for BE and to evaluate for objective signs of GERD. These guidelines also suggest endoscopic therapy as an alternative for management of patients with chronic confirmed GERD. We have also provided a GERD management algorithm based on evidence and guidance from this document (Fig. 1 ).

GUIDELINE UPDATE

ASGE guidelines are reviewed for updates approximately every 5 years or in the event that new data may influence a recommendation. Updates follow the same ASGE guideline development process.

n. Updates follow the same ASGE guideline development process.

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DISCLOSURE

Summary of recommendations

ACKNOWLEDGMENTS

References

EN_PAPER

American Society for Gastrointestinal Endoscopy guideline on the diagnosis and management of GERD: summary and recommendations Prepared by: THE ASGE STANDARDS OF PRACTICE COMMITTEE

Authors

Abstract

This guideline document was prepared by the Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy using the best available scien-tific evidence and considering a multitude of variables including but not limited to adverse events, patient values, and cost implications. The purpose of these

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy (ASGE) provides an evidence-based approach for strategies to diagnose and manage GERD. This document was developed using the Grading of Recommendations Assessment, Development, and Evaluation framework and serves as an update to the 2014 ASGE guideline on the role of endoscopy in the management of GERD. This updated guideline addresses the indications for endoscopy in patients with GERD as well as in the emerging population of patients who develop GERD after sleeve gastrectomy or peroral endoscopic myotomy. It also discusses how to endoscopically evaluate gastroesophageal junctional integrity in a comprehensive and uniform manner. Importantly, this guideline also discusses management strategies for GERD including the role of lifestyle interventions, proton pump inhibitors (PPIs), and endoscopic antireflux therapy (including transoral incisionless fundoplication [TIF], radiofrequency energy, and combined hiatal hernia repair and TIF [cTIF] ) in the management of GERD. The ASGE suggests upper endoscopy for the evaluation of GERD in patients with alarm symptoms, with multiple risk factors for Barrett's esophagus, and with a history of sleeve gastrectomy. The ASGE recommends careful endoscopic evaluation, reporting, and photo-documentation of objective GERD findings with attention to gastroesophageal junction landmarks and integrity in patients who undergo upper endoscopy to improve care. In patients with GERD symptoms, the ASGE recommends lifestyle modifications. In patients with symptomatic and confirmed GERD with predominant heartburn symptoms, the ASGE recommends medical management including PPIs at the lowest dose for the shortest duration possible while initiating discussion about long-term management options. In patients with confirmed GERD with small hiatal hernias (2 cm) and Hill grade I or II who meet specific criteria, the ASGE suggests evaluation for TIF as an alternative to chronic medical management. In patients with persistent GERD with large hiatal hernias ( > 2cm) and Hill grade III or IV, the ASGE suggests either cTIF or surgical therapy based on multidisciplinary review. This document summarizes the methods, analyses, and decision processes used to reach the final recommendations and represents the official ASGE recommendations on the above topics. (Gastrointest Endosc 2024;-:1-18.) guidelines is to provide the best practice recommendations that may help standardize patient care, improve patient outcomes, and reduce variability in practice. We recognize that clinical decision-making is complex. Guidelines, therefore, are not a substitute for a clinician's judgment. Such judgments may at times seem contradictory to our guidance because of many factors that are impossible to fully consider by guideline developers. Any clinical decisions should be based on the clinician's experience, local expertise, resource availability, and patient values and preferences. This document is not a rule and should not be construed as establishing a legal standard of care or as encouraging, advocating for, mandating, or discouraging any particular treatment. Our guidelines should not be used in support of medical complaints, legal proceedings, and/or litigation as they were not designed for this purpose.

] [3] [4] GERD can also be present in the pediatric population but may be difficult to establish because of patients' limitations in describing these symptoms. 5 Chronic uncontrolled acid reflux could lead to several adverse events including erosive esophagitis, peptic stricture, Barrett's esophagus (BE), and esophageal adenocarcinoma. The incidence of GERD and GERD-related consequences appears to be increasing in parallel with global prevalence of obesity. 6 n addition, GERD can result in poor quality of life and increased healthcare costs to individuals and the healthcare system because of frequent physician visits, endoscopies, and treatment of GERD-related consequences. 7, 8 ince the publication of the previous American Society for Gastrointestinal Endoscopy (ASGE) guideline on GERD, 9 there have been several endoscopic advancements that can affect the diagnosis and management of GERD. These include evolving indications for endoscopy among patients after sleeve gastrectomy (SG) and peroral endoscopic myotomy (POEM) in addition to updated guidance regarding endoscopic antireflux therapies. Therefore, the ASGE aimed to develop an updated and revised evidence-based guideline on the diagnosis and management of GERD.

METHODS

This document was prepared by the Standards of Practice Committee of the ASGE and was conceptualized and conducted according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) frame-work. 10 The recommendations in this summary document were carefully crafted and informed by the best available evidence. Evidence profiles were created by GRADE methodologists. Evidence was presented to a panel of experts representing various stakeholders in a meeting held in the IT & T center, Chicago, Illinois, USA on March 10, 2023. All panel members were required to disclose potential financial and intellectual conflicts of interests, which were addressed according to ASGE policies. Panelists and primary methodologists with conflicts of interest were excluded from voting on final recommendations.

In developing these recommendations, we took into consideration the certainty of the evidence, benefits and harms of different management options, feasibility, patient values and preferences, resource utilization, cost-effectiveness, and health equity, wherever possible. Final approval of each recommendation was based on a simple majority among the panel members. The final wording of the recommendations including direction and strength were approved by all members of the panel. The final wording of our recommendations was approved by all members of the panel and the ASGE Governing Board. Stronger recommendations are represented using statements such as "we recommend.," whereas weaker recommendations are represented by statements such as "we suggest.." This document, subtitled "Summary and Recommendations," provides our final recommendations as well as a high-level summary of the evidence-based guideline process that was followed by the ASGE in preparing this document. Further details on methodology and evidence synthesis process are provided separately including details of our literature search, data analyses, pooled-effects estimates, evidence profiles, forest plots, and panel deliberation for each outcome in the accompanying methodology and technical review document.

This guideline addressed the following clinical domains in the following categories using the GRADE format: endoscopy in specific patient populations to evaluate for GERD (questions 1a, 1b, and 1c), performance of a high-quality endoscopy (question 2), lifestyle interventions for management of GERD (question 3), use of proton pump inhibitors (PPIs) in GERD (question 4), and endoscopic management of GERD (questions 5 and 6). Relevant clinical outcomes included symptom remission, adverse events, objective improvement of GERD, durable response, and PPI discontinuation.

External review

The guideline was reviewed by the Gastrointestinal Endoscopy Editorial Board and ASGE Governing Board and made available for public comment on the ASGE website for 30 days between March 1 and April 1, 2024.

RESULTS AND SUMMARY OF RECOMMENDATIONS

A summary of our final recommendations for management of patients with GERD is listed in Table 1 . A management algorithm for patients with GERD is provided in Figure 1 .

Question 1a: In patients with GERD symptoms, when should upper endoscopy be performed compared with no endoscopy? Recommendation 1a: I. In patients with GERD symptoms, the ASGE recommends upper endoscopy in those with Alarm symptoms (dysphagia, odynophagia, weight loss, GI bleeding, persistent vomiting, or unexplained iron deficiency anemia).

(Strong recommendation, moderate-quality evidence) II. In patients with GERD symptoms but no alarm symptoms, the ASGE suggests endoscopic evaluation in those with BE risk factors (family history of BE or esophageal adenocarcinoma; GERD plus another risk factor [50 years, male sex, white race, smoking, or obesity]).

Infants and children with suggestive symptoms (poor weight gain, unexplained anemia, concern for GI bleeding, recurrent pneumonia, regurgitation and/or vomiting).

(Conditional recommendation, low-quality evidence)

For this outcome, we used existing consensus from our previous guidelines. 9, 11 A clinical diagnosis of GERD can be made based on symptoms and confirmed by a favorable symptomatic response to antisecretory medical therapy. If the patient's symptoms are consistent with typical or uncomplicated GERD, an initial trial of empirical medical therapy is appropriate before consideration of endoscopy in most patients without alarm symptoms. However, endoscopy at presentation should be considered in patients who have symptoms suggestive of advanced pathology or adverse events of GERD (ie, stricture). Endoscopy is therefore recommended for patients with alarm symptoms including dysphagia, odynophagia, weight loss, GI bleeding, and anemia.

The panel discussed that a high-quality EGD should be performed when alarm symptoms have occurred after a recent endoscopic evaluation in the absence of such symptoms. EGD may be necessary to detect erosive esophagitis, peptic stricture, esophageal cancer, gastric or esophageal outlet obstruction, and other potentially significant upper GI tract findings. Previous ASGE guidelines suggest screening endoscopy in at-risk patients, which is defined as individuals with a family history of BE or esophageal adenocarcinoma or patients with GERD plus at least 1 other risk factor. 9 The panel recognized recent guidelines suggesting screening for patients with multiple risk factors (without necessarily having GERD as a prerequisite) 11 because many patients with GERD and BE are asymptomatic. 12 dditionally, EGD should be considered as part of the preoperative evaluation of patients being considered for antireflux surgery or for the placement of wireless esophageal pH monitoring devices and is an inherent part of various endoscopic antireflux procedures. The panel supported these established recommendations, and these were incorporated into the existing indications for endoscopy for GERD.

Question 1b: In patients who had SG, should endoscopy be performed to screen for BE compared with no endoscopy?

Recommendation 1b:

In patients who had SG and with reflux symptoms, the ASGE suggests endoscopic evaluation.

In patients who had SG and are asymptomatic, the ASGE suggests endoscopic screening for 3 years after SG and then every 5 years.

If BE is detected in this population, the ASGE recommends follow-up per existing BE surveillance guidelines.

We found no prospective studies examining the utility of a screening EGD after SG for BE in terms of survival (or other events) or cost-effectiveness of screening in this population. We identified a systematic review by Qumseya et al 13 that assessed the rate of de novo BE after SG. Among 10 observational studies where 680 patients did not have BE before undergoing SG, 11.4% (54/680) developed BE after SG (7.7%-16.6%, P < .001, I 2 Z 28.7%) at followup ranging from 6 months to 10 years. In 5 studies with long-term follow-up, the relative increase in the rate of esophagitis was 86% (64%-109%, P < .001, ] [16] [17] [18] [19] Meta-regression showed that the risk of esophagitis increased by 8% each year. We did not find any relevant data on patient values and preferences.

The panel noted that this risk of BE crosses the 10% threshold set by previous guidelines and thus suggested

Strength of recommendation

Quality of the evidence

In patients with GERD symptoms, the ASGE recommends upper endoscopy in those with alarm symptoms (dysphagia, odynophagia, weight loss, GI bleeding, persistent vomiting, or unexplained iron deficiency anemia).

Strong Moderate

In patients with GERD symptoms with no alarm symptoms, the ASGE suggests endoscopic evaluation in Those with Barrett's esophagus risk factors (family history of Barrett's esophagus or esophageal adenocarcinoma; GERD plus another risk factor [ > 50 y, male sex, white race, smoking, and obesity]).

Infants and children with suggestive symptoms (poor weight gain, unexplained anemia, concern for GI bleeding, recurrent pneumonia, regurgitation, and/or vomiting).

Conditional Low

In patients after sleeve gastrectomy with reflux symptoms, the ASGE suggests endoscopic evaluation. In patients after sleeve gastrectomy who are asymptomatic, the ASGE suggests endoscopic screening 3 y after sleeve gastrectomy and then every 5 y. If Barrett's esophagus is detected in this population, the ASGE recommends follow-up per existing Barrett's esophagus surveillance guidelines.

Conditional Very low

In patients after peroral endoscopic myotomy who have symptomatic GERD, the ASGE suggests endoscopic evaluation.

In patients after peroral endoscopic myotomy, endoscopists should be aware of the high rate of GERD after peroral endoscopic myotomy and should consider periodic endoscopic evaluation in asymptomatic patients.

In patients undergoing endoscopic evaluation for GERD symptoms, the ASGE recommends careful endoscopic evaluation, reporting, and photodocumentation of the following to improve patient care and outcomes: Objective GERD findings, when present: o Erosive esophagitis (using Los screening in this patient population. 11, 20 Screening is suggested to start at 3 years, regardless of the presence of GERD symptoms, and should continue every 5 years thereafter. If BE is found, then surveillance should follow the recommendations of the previous ASGE guidance. 11 estion 1c: In patients who had POEM and have reflux symptoms, should endoscopy be performed compared with no endoscopy? Recommendation 1c: In patients who had POEM and have symptomatic GERD, the ASGE suggests endoscopic evaluation.

Best practice advice: In patients who had POEM, endoscopists should be aware of the high rate of GERD after POEM and should consider periodic endoscopic evaluation in asymptomatic patients.

For this question, we performed a systematic review of studies examining the incidence of de novo GERD after POEM. Outcomes of interest were GERD, erosive esophagitis, and BE. We identified 3 existing systematic reviews and metaanalyses [21] [22] [23] and 2 randomized controlled trials (RCTs). 24, 25 a meta-analysis of 17 observational studies (follow-up, 2-30 months), the rate of post-POEM de novo GERD was 19% (245/1275; 15.7%-22.8%, I 2 Z 43.3%, P Z .024). 21 The pooled rate of esophagitis was 29.4% (449/1056; 18.5%-43.3%, I 2 Z 93%, P < .01). In a meta-analysis of 11 studies encompassing 2342 patients that examined GERD after POEM with a median follow-up of 48 months (2017-2021), the pooled rate of symptomatic reflux was 22.0% (95% confidence interval [CI], 14.4-29.5; I 2 Z 73.1%, P < .01), with 3 cases of peptic strictures and 1 case of BE identified. 23 We did not identify other longterm data reporting a high rate of BE after POEM. We did not identify studies reporting patient values, cost-effectiveness, mortality, or benefits from surveillance or equity.

Overall, the evidence was noted to be of very low quality. The panel acknowledged that there was a high rate of GERD in initial studies after POEM; however, the POEM technique has also improved over time, correlating with decreased GERD rates after POEM. In addition, some studies have not examined rates of acid exposure before and after the intervention. Data on severity of esophagitis after POEM are also not consistently reported. The panel expressed concern regarding disruption of the antireflux barrier irrespective of POEM technique and acknowledged the risk of GERD after POEM. The panel also discussed the varying sensitivity for symptoms related to reflux and a higher incidence of esophagitis compared with reported symptoms among this population. Squamous cell cancer

In patients with suboptimal clinical response to PPI therapy, the ASGE suggests testing for CYP2C19 polymorphism and adjusting PPI dosage and selection accordingly.

In patients with confirmed GERD with a small hiatal hernia (2 cm) and Hill grade I or II who meet any of the following criteria, the ASGE suggests evaluation for transoral incisionless fundoplication as an alternative to chronic medical management: Chronic GERD (at least 6 months) Chronic PPI use (6 mo) for management for GERD symptoms Refractory GERD Regurgitation-predominant GERD Patient prefers to avoid long-term PPI use

In patients with confirmed GERD with a large hiatal hernia ( > 2 cm) and Hill grade III or IV, the ASGE suggests evaluation for combined hiatal hernia repair and transoral incisionless fundoplication in a multidisciplinary review.

In patients with confirmed GERD and small hiatal hernias ( < 2 cm) and Hill grade I or II, Stretta can be considered when other alternatives (endoscopic/ surgical fundoplication) are not available or feasible.

ASGE, American Society for Gastrointestinal Endoscopy; PPI, proton pump inhibitor.

of the esophagus is associated with long-term achalasia, and esophageal adenocarcinoma is associated with longstanding acid reflux. Therefore, the panel acknowledged the utility of endoscopy in achalasia patients after POEM; however, the evidence in favor of EGD for all these patients is insufficient. The panel did make a conditional recommendation for EGD for further evaluation only in symptomatic patients after POEM.

This was an important question to address for our guideline panel, especially given recent advancements in the endoscopic management of GERD. This is not a comparative question and thus did not follow the PICO (population, intervention, comparator, outcome) format. We performed a literature search for studies reporting the use of endoscopic evaluation modalities for GERD. Limited data describe the standardization of procedural documentation of upper endoscopies including documentation of the gastroesophageal junction. A study demonstrated that endoscopists are inconsistent in their reporting of upper endoscopies. 26 Specifically, esophagitis was documented in only one-third of patients and was graded in 42%. Furthermore, a hiatal hernia was noted in 61% of patients but only measured in 51% and further classified in 26%.

The panel agreed on the need to standardize endoscopy procedural documentation in patients with GERD because there can be negative consequences with failure to do so, including the need for a repeat endoscopy to characterize hiatal hernias and to document landmarks including the gastroesophageal junction before endoscopic or surgical therapy. This could subsequently delay therapeutic management and increase costs and risks associated with additional endoscopy. 27 The panel unanimously agreed that reporting objective findings of GERD is important, such as the presence of erosive esophagitis (Fig. 2A ), BE (Prague classification) (Fig. 2B ), 28 and peptic strictures. Los Angeles grading should be used to assess the severity of esophagitis. 29 The panel also agreed that reporting gastroesopha-geal junction landmarks and integrity is important. These include descriptions of hiatal hernia size, presence or absence of a flap valve using the forward endoscopic view and retroflexion in fundus, and use of Hill grading 30 or American Foregut Society classification (Fig. 2C ) for gastroesophageal junction integrity and hiatus. 31 The panel also discussed the importance of adequate mucosal inspection and cleanliness (including use of existing scales, ie, Barcelona scale 32 and Toronto Upper Gastrointestinal Cleaning Score 33 ) to ensure detection of any precancerous lesions before making definitive management decisions and emphasized achieving a high-quality inspection during the standard EGD.

For this question, we performed a systematic literature search to evaluate the role of different lifestyle modifications (eg, weight loss, smoking cessation, head of bed elevation, late evening meals) on reduction of GERD symptoms. Weight loss was associated with a decrease in GERD symptoms and acid exposure time (3 RCTs [34] [35] [36] ) and improvement in reflux disease questionnaire scores (1 RCT 37 ). Large populationbased studies showed a linear relationship between body mass index and GERD symptoms. 38, 39 Smoking cessation was associated with decreased reflux symptoms. 40, 41 Elevating the head of the bed was linked to lower reflux episodes 42 and decreased acid exposure. 43 A late evening meal was associated with increased reflux. 44 On the other hand, we did not identify any data to demonstrate that alcohol cessation improves GERD symptoms to make a recommendation.

引用 / 出处

2024 ASGE指南：胃食管反流病的诊断和管理（概要和建议）. 2024.