American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in the diagnosis and management of solid pancreatic masses: summary and recommendations.

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy (ASGE) provides an evidence-based approach for the role of endoscopy in the diagnosis and management of pancreatic masses. This document was developed using the Grading of Recommendations Assessment, Development and Evaluation framework and addresses needle selection (fine-needle biopsy [FNB] needle vs FNA needle), needle caliber (22-gauge vs 25-gauge needles), FNB needle type (novel or contemporary [fork-tip and Franseen] vs alternative FNB needle designs), and sample processing (rapid on-site evaluation [ROSE] vs no ROSE). In addition, this guideline addresses stent selection (self-expandable metal stent [SEMS] vs plastic stent), SEMS type (covered [cSEMS] vs uncovered [uSEMS]), and pain management (celiac plexus neurolysis [CPN] vs medical analgesic therapy). In patients with solid pancreatic masses undergoing EUS-guided tissue acquisition (EUS-TA), the ASGE recommends FNB needles over FNA needles. With regard to needle caliber, the ASGE suggests 22-gauge over 25-gauge needles. When an FNB needle is used, the ASGE recommends using either a fork-tip or a Franseen needle over alternative FNB needle designs. After a sample has been obtained, the ASGE suggests against the routine use of ROSE in patients undergoing an initial EUS-TA of a solid pancreatic mass. In patients with distal malignant biliary obstruction undergoing drainage with ERCP, the ASGE suggests using SEMSs over plastic stents. In patients with proven malignancy undergoing SEMS placement, the ASGE suggests using cSEMSs over uSEMSs. If malignancy has not been histopathologically confirmed, the ASGE recommends against the use of uSEMSs. Finally, in patients with unresectable pancreatic cancer and abdominal pain, the ASGE suggests the use of CPN as an adjunct for the treatment of abdominal pain. This document outlines the process, analyses, and decision approaches used to reach the final recommendations and represents the official ASGE recommendations on the above topics.

American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in the management of chronic pancreatitis: summary and recommendations.

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy (ASGE) provides an evidence-based approach for the role of endoscopy in the management of chronic pancreatitis (CP). This document was developed using the Grading of Recommendations Assessment, Development and Evaluation framework. The guideline addresses effectiveness of endoscopic therapies for the management of pain in CP, including celiac plexus block, endoscopic management of pancreatic duct (PD) stones and strictures, and adverse events such as benign biliary strictures (BBSs) and pseudocysts. In patients with painful CP and an obstructed PD, the ASGE suggests surgical evaluation in patients without contraindication to surgery before initiation of endoscopic management. In patients who have contraindications to surgery or who prefer a less-invasive approach, the ASGE suggests an endoscopic approach as the initial treatment over surgery, if complete ductal clearance is likely. When a decision is made to proceed with a celiac plexus block, the ASGE suggests an EUS-guided approach over a percutaneous approach. The ASGE suggests indications for when to consider ERCP alone or with pancreatoscopy and extracorporeal shock wave lithotripsy alone or followed by ERCP for treating obstructing PD stones based on size, location, and radiopacity. For the initial management of PD strictures, the ASGE suggests using a single plastic stent of the largest caliber that is feasible. For symptomatic BBSs caused by CP, the ASGE suggests the use of covered metal stents over multiple plastic stents. For symptomatic pseudocysts, the ASGE suggests endoscopic therapy over surgery. This document clearly outlines the process, analyses, and decision processes used to reach the final recommendations and represents the official ASGE recommendations on the above topics.

American Society for Gastrointestinal Endoscopy guideline on the role of therapeutic EUS in the management of biliary tract disorders: summary and recommendations.

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy provides an evidence-based approach for the role of therapeutic EUS in the management of biliary tract disorders. This guideline was developed using the Grading of Recommendations Assessment, Development and Evaluation framework and addresses the following: 1: The role of EUS-guided biliary drainage (EUS-BD) versus percutaneous transhepatic biliary drainage (PTBD) in resolving biliary obstruction in patients after failed ERCP. 2: The role of EUS-guided hepaticogastrostomy versus EUS-guided choledochoduodenostomy in resolving distal malignant biliary obstruction after failed ERCP. 3: The role of EUS-directed transgastric ERCP (EDGE) versus laparoscopic-assisted ERCP and enteroscopy-assisted ERCP (E-ERCP) in resolving biliary obstruction in patients with Roux-en-Y gastric bypass (RYGB) anatomy. 4: The role of EUS-BD versus E-ERCP and PTBD in resolving biliary obstruction in patients with surgically altered anatomy other than RYGB. 5: The role of EUS-guided gallbladder drainage (EUS-GBD) versus percutaneous gallbladder drainage and endoscopic transpapillary transcystic gallbladder drainage in resolving acute cholecystitis in patients who are not candidates for cholecystectomy.

American Society for Gastrointestinal Endoscopy guideline on management of post-liver transplant biliary strictures: summary and recommendations.

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy provides an evidence-based approach for strategies to manage biliary strictures in liver transplant recipients. This document was developed using the Grading of Recommendations Assessment, Development and Evaluation framework. The guideline addresses the role of ERCP versus percutaneous transhepatic biliary drainage and covered self-expandable metal stents (cSEMSs) versus multiple plastic stents for therapy of post-transplant strictures, use of MRCP for diagnosing post-transplant biliary strictures, and administration of antibiotics versus no antibiotics during ERCP. In patients with post-transplant biliary strictures, we suggest ERCP as the initial intervention and cSEMSs as the preferred stent for extrahepatic strictures. In patients with unclear diagnoses or intermediate probability of a stricture, we suggest MRCP as the diagnostic modality. We suggest that antibiotics should be administered during ERCP when biliary drainage cannot be ensured.

American Society for Gastrointestinal Endoscopy guideline on management of post-liver transplant biliary strictures: methodology and review of evidence.

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy provides an evidence-based approach for strategies to manage biliary strictures in liver transplant recipients. This document was developed using the Grading of Recommendations Assessment, Development and Evaluation framework. The guideline addresses the role of ERCP versus percutaneous transhepatic biliary drainage and covered self-expandable metal stents (cSEMSs) versus multiple plastic stents for therapy of strictures, use of MRCP for diagnosing post-transplant biliary strictures, and administration of antibiotics versus no antibiotics during ERCP. In patients with post-transplant biliary strictures, we suggest ERCP as the initial intervention and cSEMSs as the preferred stent. In patients with unclear diagnosis or intermediate probability of a stricture, we suggest MRCP as the diagnostic modality. We suggest that antibiotics should be administered during ERCP when biliary drainage cannot be assured.

American Society for Gastrointestinal Endoscopy guideline on the role of ergonomics for prevention of endoscopy-related injury: summary and recommendations.

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy provides an evidence-based approach to strategies to prevent endoscopy-related injury (ERI) in GI endoscopists. It is accompanied by the article subtitled "Methodology and Review of Evidence," which provides a detailed account of the methodology used for the evidence review. This document was developed using the Grading of Recommendations Assessment, Development and Evaluation framework. The guideline estimates the rates, sites, and predictors of ERI. Additionally, it addresses the role of ergonomics training, microbreaks and macrobreaks, monitor and table positions, antifatigue mats, and use of ancillary devices in decreasing the risk of ERI. We recommend formal ergonomics education and neutral posture during the performance of endoscopy, achieved through adjustable monitor and optimal procedure table position, to reduce the risk of ERI. We suggest taking microbreaks and scheduled macrobreaks and using antifatigue mats during procedures to prevent ERI. We suggest the use of ancillary devices in those with risk factors predisposing them to ERI.

American Society for Gastrointestinal Endoscopy guideline on endoscopic submucosal dissection for the management of early esophageal and gastric cancers: methodology and review of evidence.

This document from the American Society for Gastrointestinal Endoscopy (ASGE) provides a full description of the methodology used in the review of the evidence used to inform the final guidance outlined in the accompanying Summary and Recommendations document regarding the role of endoscopic submucosal dissection (ESD) in the management of early esophageal and gastric cancers. This guideline used the Grading of Recommendations, Assessment, Development and Evaluation framework and specifically addresses the role of ESD versus EMR and/or surgery, where applicable, for the management of early esophageal squamous cell carcinoma (ESCC), esophageal adenocarcinoma (EAC), and gastric adenocarcinoma (GAC) and their corresponding precursor lesions. For ESCC, the ASGE suggests ESD over EMR for patients with early-stage, well-differentiated, nonulcerated cancer >15 mm, whereas in patients with similar lesions ≤15 mm, the ASGE suggests either ESD or EMR. The ASGE suggests against surgery for such patients with ESCC, whenever possible. For EAC, the ASGE suggests ESD over EMR for patients with early-stage, well-differentiated, nonulcerated cancer >20 mm, whereas in patients with similar lesions measuring ≤20 mm, the ASGE suggests either ESD or EMR. For GAC, the ASGE suggests ESD over EMR for patients with early-stage, well or moderately differentiated, nonulcerated intestinal type cancer measuring 20 to 30 mm, whereas for patients with similar lesions <20 mm, the ASGE suggests either ESD or EMR. The ASGE suggests against surgery for patients with such lesions measuring ≤30 mm, whereas for lesions that are poorly differentiated, regardless of size, the ASGE suggests surgical evaluation over endosic approaches.

American Society for Gastrointestinal Endoscopy guideline on endoscopic submucosal dissection for the management of early esophageal and gastric cancers: summary and recommendations.

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy (ASGE) provides an evidence-based summary and recommendations regarding the role of endoscopic submucosal dissection (ESD) in the management of early esophageal and gastric cancers. It is accompanied by the document subtitled "Methodology and Review of Evidence," which provides a detailed account of the methodology used for the evidence review. This guideline was developed using the Grading of Recommendations, Assessment, Development and Evaluation framework and specifically addresses the role of ESD versus EMR and/or surgery, where applicable, for the management of early esophageal squamous cell carcinoma (ESCC), esophageal adenocarcinoma (EAC), and gastric adenocarcinoma (GAC) and their corresponding precursor lesions. For ESCC, the ASGE suggests ESD over EMR for patients with early-stage, well-differentiated, nonulcerated cancer >15 mm, whereas in patients with similar lesions ≤15 mm, the ASGE suggests either ESD or EMR. The ASGE suggests against surgery for such patients with ESCC, whenever possible. For EAC, the ASGE suggests ESD over EMR for patients with early-stage, well-differentiated, nonulcerated cancer >20 mm, whereas in patients with similar lesions measuring ≤20 mm, the ASGE suggests either ESD or EMR. For GAC, the ASGE suggests ESD over EMR for patients with early-stage, well- or moderately differentiated, nonulcerated intestinal type cancer measuring 20 to 30 mm, whereas for patients with similar lesions <20 mm, the ASGE suggests either ESD or EMR. The ASGE suggests against surgery for patients with such lesions measuring ≤30 mm, whereas for lesions that are poorly differentiated, regardless of size, we suggest surgical evaluation over endoscopic approaches.

American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in the diagnosis of malignancy in biliary strictures of undetermined etiology: summary and recommendations.

This clinical practice guideline from the American Society for Gastrointestinal Endoscopy provides an evidence-based approach for the diagnosis of malignancy in patients with biliary strictures of undetermined etiology. This document was developed using the Grading of Recommendations Assessment, Development and Evaluation framework and addresses the role of fluoroscopic-guided biopsy sampling, brush cytology, cholangioscopy, and EUS in the diagnosis of malignancy in patients with biliary strictures. In the endoscopic workup of these patients, we suggest the use of fluoroscopic-guided biopsy sampling in addition to brush cytology over brush cytology alone, especially for hilar strictures. We suggest the use of cholangioscopic and EUS-guided biopsy sampling especially for patients who undergo nondiagnostic sampling, cholangioscopic biopsy sampling for nondistal strictures and EUS-guided biopsy sampling distal strictures or those with suspected spread to surrounding lymph nodes and other structures.

American Society for Gastrointestinal Endoscopy guideline on role of endoscopy in the diagnosis of malignancy in biliary strictures of undetermined etiology: methodology and review of evidence.

Biliary strictures of undetermined etiology pose a diagnostic challenge for endoscopists. Despite advances in technology, diagnosing malignancy in biliary strictures often requires multiple procedures. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework was used to rigorously review and synthesize the available literature on strategies used to diagnose undetermined biliary strictures. Using a systematic review and meta-analysis of each diagnostic modality, including fluoroscopic-guided biopsy sampling, brush cytology, cholangioscopy, and EUS-guided FNA or fine-needle biopsy sampling, the American Society for Gastrointestinal Endoscopy Standards of Practice Committee provides this guideline on modalities used to diagnose biliary strictures of undetermined etiology. This document summarizes the methods used in the GRADE analysis to make recommendations, whereas the accompanying article subtitled "Summary and Recommendations" contains a concise summary of our findings and final recommendations.

A novel through-the-scope helix tack-and-suture device for mucosal defect closure following colorectal endoscopic submucosal dissection: a multicenter study.

BACKGROUND: Complete closure of large mucosal defects following colorectal endoscopic submucosal dissection (ESD) with through-the-scope (TTS) clips is oftentimes not possible. We aimed to report our early experience of using a novel TTS suturing system for the closure of large mucosal defects after colorectal ESD. METHODS: We performed a retrospective multicenter cohort study of consecutive patients who underwent attempted prophylactic defect closure using the TTS suturing system after colorectal ESD. The primary outcome was technical success in achieving complete defect closure, defined as a < 5 mm residual mucosal defect in the closure line using TTS suturing, with or without adjuvant TTS clips. RESULTS: 82 patients with a median defect size of 30 (interquartile range 25-40) mm were included. Technical success was achieved in 92.7 % (n = 76): TTS suturing only in 44 patients (53.7 %) and a combination of TTS suturing to approximate the widest segment followed by complete closure with TTS clips in 32 (39.0 %). Incomplete/partial closure, failure of appropriate TTS suture deployment, and the need for over-the-scope salvage closure methods were observed in 7.3 % (n = 6). One intraprocedural bleed, one delayed bleed, and three intraprocedural perforations were observed. There were no adverse events related to placement of the TTS suture. CONCLUSION: The TTS suture system is an effective and safe tool for the closure of large mucosal defects after colorectal ESD and is an alternative when complete closure with TTS clips alone is not possible.

American Society for Gastrointestinal Endoscopy guideline on informed consent for GI endoscopic procedures.

Informed consent is the cornerstone of the ethical practice of procedures and treatments in medicine. The purpose of this document from the American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee is to provide an update on best practice of the informed consent process and other issues around informed consent and shared decision-making for endoscopic procedures. The principles of informed consent are based on longstanding legal doctrine. Several new concepts and clinical trials addressing the best practice of informed consent will help guide practitioners of the burgeoning field of GI endoscopic procedures. After a literature review and an iterative discussion and voting process by the ASGE Standards of Practice Committee, this document was produced to update our guidance on informed consent for the practicing endoscopist. Because this document was designed by considering the laws and broad practice of endoscopy in the United States, legal requirements may differ by state and region, and it is the responsibility of the endoscopist, practice managers, and other healthcare organizations to be aware of local laws. Our recommendations are designed to improve the informed consent experience for both physicians and patients as they work together to diagnose and treat GI diseases with endoscopy.

Quality assessment for systematic reviews and meta-analyses of cohort studies.

BACKGROUND AND AIMS: There is a growing need for valid, efficient, and easy scoring scales to rate the quality of cohort studies. We aimed to develop and validate a quality assessment score to be used for cohort studies. METHODS: We followed a rigorous process to establish content, face, and construct validity. Most questions were scored at 0 or 1. Inter-rater reliability and test-retest reliability were assessed using the Spearman correlation coefficient (rs) and Cohen's κ statistic. Internal consistency was measured using the Kuder-Richardson formula 20 (KR20). RESULTS: The final tool consists of 9 questions with a maximum score of 10. The inter-rater reliability was high with the Spearman correlation coefficient (rs = .66). Agreement for inclusion was 90%. Test-retest reliability was high. For rater 1, rs = .91, κ = .38 for scores, and κ = 1 for inclusion. For rater 2, r = .94, 80% agreement for scores, and 100% agreement for inclusion. Internal consistency was reasonable based on 2 studies: KR20 = .21 and KR20 = .65. The novel scale rated highest in efficiency, understandably, ease of use, and ease of interpretation when compared with 3 other scales. CONCLUSIONS: This novel scale has favorable performance characteristics, is efficient to conduct, and is easy to interpret and will be very helpful for physicians and researchers conducting systematic reviews and meta-analyses.

Barrett's esophagus after sleeve gastrectomy: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Sleeve gastrectomy (SG) has become significantly more common in recent years. Gastroesophageal reflux disease (GERD) is a major concern in patients undergoing SG and is the major risk factor for Barrett's esophagus (BE). We aimed to assess the prevalence of BE in patients who had undergone SG. METHODS: We searched the major search engines ending in July 2020. We included studies on patients who had undergone esophagogastroduodenoscopy (EGD) after SG. The primary outcome was the prevalence of BE in patients who had undergone SG. We assessed heterogeneity using I2 and Q statistics. We used funnel plots and the classic fail-safe test to assess for publication bias. We used random-effects modeling to report effect estimates. RESULTS: Our final analysis included 10 studies that included 680 patients who had undergone EGD 6 months to 10 years after SG. The pooled prevalence of BE was 11.6% (95% confidence interval [CI], 8.1%-16.4%; P < .001; I2 = 28.7%). On logistic meta-regression analysis, there was no significant association between BE and the prevalence of postoperative GERD (ß = 3.5; 95% CI, -18 to 25; P = .75). There was a linear relationship between the time of postoperative EGD and the rate of esophagitis (ß = 0.13; 95% CI, 0.06-0.20; P = .0005); the risk of esophagitis increased by 13% each year after SG. CONCLUSIONS: The prevalence of BE in patients who had EGD after SG appears to be high. There was no correlation with GERD symptoms. Most cases were observed after 3 years of follow-up. Screening for BE should be considered in patients after SG even in the absence of GERD symptoms postoperatively.

ASGE guideline on the management of cholangitis.

Cholangitis is a GI emergency requiring prompt recognition and treatment. The purpose of this document from the American Society for Gastrointestinal Endoscopy's (ASGE) Standards of Practice Committee is to provide an evidence-based approach for management of cholangitis. This document addresses the modality of drainage (endoscopic vs percutaneous), timing of intervention (<48 hours vs >48 hours), and extent of initial intervention (comprehensive therapy vs decompression alone). Grading of Recommendations, Assessment, Development, and Evaluation methodology was used to formulate recommendations on these topics. The ASGE suggests endoscopic rather than percutaneous drainage and biliary decompression within 48 hours. Additionally, the panel suggests that sphincterotomy and stone removal be combined with drainage rather than decompression alone, unless patients are too unstable to tolerate more extensive endoscopic treatment.

ASGE guideline on the role of endoscopy in the management of malignant hilar obstruction.

This clinical guideline from the American Society for Gastrointestinal Endoscopy (ASGE) provides an evidence-based approach for the management of patients with malignant hilar obstruction (MHO). This document was developed using the Grading of Recommendations Assessment, Development and Evaluation framework and addresses primary drainage modality (percutaneous transhepatic biliary drainage [PTBD] vs endoscopic biliary drainage [EBD]), drainage strategy (unilateral vs bilateral), and stent selection (plastic stent [PS] vs self-expandable metal stent [SEMS]). Regarding drainage modality, in patients with MHO undergoing drainage before potential resection or transplantation, the panel suggests against routine use of PTBD as first-line therapy compared with EBD. In patients with unresectable MHO undergoing palliative drainage, the panel suggests PTBD or EBD. The final decision should be based on patient preferences, disease characteristics, and local expertise. Regarding drainage strategy, in patients with unresectable MHO undergoing palliative stent placement, the panel suggests placement of bilateral stents compared with a unilateral stent in the absence of liver atrophy. Finally, regarding type of stent, in patients with unresectable MHO undergoing palliative stent placement, the panel suggests placing SEMSs or PSs. However, in patients who have a short life expectancy and who place high value on avoiding repeated interventions, the panel suggests using SEMSs compared with PSs. If optimal drainage strategy has not been established, the panel suggests placing PSs. This document clearly outlines the process, analyses, and decision processes used to reach the final recommendations and represents the official ASGE recommendations on the above topics.

ASGE guideline on the role of endoscopy in the management of benign and malignant gastroduodenal obstruction.

This American Society for Gastrointestinal Endoscopy guideline provides evidence-based recommendations for the endoscopic management of gastric outlet obstruction (GOO). We applied the Grading of Recommendations, Assessment, Development and Evaluation methodology to address key clinical questions. These include the comparison of (1) surgical gastrojejunostomy to the placement of self-expandable metallic stents (SEMS) for malignant GOO, (2) covered versus uncovered SEMS for malignant GOO, and (3) endoscopic and surgical interventions for the management of benign GOO. Recommendations provided in this document were founded on the certainty of the evidence, balance of benefits and harms, considerations of patient and caregiver preferences, resource utilization, and cost-effectiveness.

American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in the management of acute colonic pseudo-obstruction and colonic volvulus.

Colonic volvulus and acute colonic pseudo-obstruction (ACPO) are 2 causes of benign large-bowel obstruction. Colonic volvulus occurs most commonly in the sigmoid colon as a result of bowel twisting along its mesenteric axis. In contrast, the exact pathophysiology of ACPO is poorly understood, with the prevailing hypothesis being altered regulation of colonic function by the autonomic nervous system resulting in colonic distention in the absence of mechanical blockage. Prompt diagnosis and intervention leads to improved outcomes for both diagnoses. Endoscopy may play a role in the evaluation and management of both entities. The purpose of this document from the American Society for Gastrointestinal Endoscopy's Standards of Practice Committee is to provide an update on the evaluation and endoscopic management of sigmoid volvulus and ACPO.

American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in familial adenomatous polyposis syndromes.

Familial adenomatous polyposis (FAP) syndrome is a complex entity, which includes FAP, attenuated FAP, and MUTYH-associated polyposis. These patients are at significant risk for colorectal cancer and carry additional risks for extracolonic malignancies. In this guideline, we reviewed the most recent literature to formulate recommendations on the role of endoscopy in this patient population. Relevant clinical questions were how to identify high-risk individuals warranting genetic testing, when to start screening examinations, what are appropriate surveillance intervals, how to identify endoscopically high-risk features, and what is the role of chemoprevention. A systematic literature search from 2005 to 2018 was performed, in addition to the inclusion of seminal historical studies. Most studies were from worldwide registries, which have compiled years of data regarding the natural history and cancer risks in this cohort. Given that most studies were retrospective, recommendations were based on epidemiologic data and expert opinion. Management of colorectal polyps in FAP has not changed much in recent years, as colectomy in FAP is the standard of care. What is new, however, is the developing body of literature on the role of endoscopy in managing upper GI and small-bowel polyposis, as patients are living longer and improved endoscopic technologies have emerged.

ASGE guideline on the management of achalasia.

Achalasia is a primary esophageal motor disorder of unknown etiology characterized by degeneration of the myenteric plexus, which results in impaired relaxation of the esophagogastric junction (EGJ), along with the loss of organized peristalsis in the esophageal body. The criterion standard for diagnosing achalasia is high-resolution esophageal manometry showing incomplete relaxation of the EGJ coupled with the absence of organized peristalsis. Three achalasia subtypes have been defined based on high-resolution manometry findings in the esophageal body. Treatment of patients with achalasia has evolved in recent years with the introduction of peroral endoscopic myotomy. Other treatment options include botulinum toxin injection, pneumatic dilation, and Heller myotomy. This American Society for Gastrointestinal Endoscopy Standards of Practice Guideline provides evidence-based recommendations for the treatment of achalasia, based on an updated assessment of the individual and comparative effectiveness, adverse effects, and cost of the 4 aforementioned achalasia therapies.