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.

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.

Effectiveness and Safety of Lumen-Apposing Metal Stents in Endoscopic Interventions for Off-Label Indications.

BACKGROUND: Although released only for drainage of pseudocyst and walled-off necrosis (WON) with ≤ 30% solid debris, the utilization of lumen-apposing metal stent (LAMS) in "real-world" practice has deviated from approved indications. We evaluated the contemporary use of LAMS and associated clinical, procedural outcomes in the setting of a tertiary referral center in the USA. METHODS: Data from 303 consecutive patients who underwent LAMS placement were analyzed. Outcomes included technical and clinical success rates and adverse events. RESULTS: Of 303 patients, 190 (62.7%) received LAMS for off-label indications. The latter included gallbladder drainage (n = 56, 18.5%), gastroenterostomy (n = 52, 17.2%), treatment of gastrointestinal strictures (n = 37, 12.2%), biliary drainage (n = 20, 6.6%), temporary gastric access for endoscopy (n = 13, 4.3%), symptomatic WON with > 30% solid debris (n = 8, 2.6%), and miscellaneous (n = 4, 1.3%). Technical success rates in the on- and off-label arm were 98.2% and 95.8%, respectively (P = .331; 95% CI 0.08 to 1.96). Clinical success rates in the on- and off-label arm were 89.4% and 83.2%, respectively (P = .137; 95% CI 0.28 to 1.19). The rate of adverse events was 20.5% (n = 39) in the off-label arm and 16.8% (n = 19) in the on-label arm (P = .242; 95% CI 0.69 to 2.34). CONCLUSION: Off-label use of LAMS out-numbered on-label use in our practice. The safety profile between the groups was similar and with the exception of refractory stricture treatment, efficacy was comparable.

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 minimum staffing requirements for the performance of GI endoscopy.

Efforts to increase patient safety and satisfaction, a critical concern for health providers, require periodic evaluation of all factors involved in the provision of GI endoscopy services. We aimed to develop guidelines on minimum staffing requirements and scope of practice of available staff for the safe and efficient performance of GI endoscopy. The recommendations in this guideline were based on a systematic review of published literature, results from a nationwide survey of endoscopy directors, along with the expert guidance of the American Society for Gastrointestinal Endoscopy (ASGE) Standards of Practice Committee members, ASGE Practice Operation Committee members, and the ASGE Governing Board.

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.

ASGE EndoVators Summit: simulators and the future of endoscopic training.

Interest in the use of simulation for acquiring, maintaining, and assessing skills in GI endoscopy has grown over the past decade, as evidenced by recent American Society for Gastrointestinal Endoscopy (ASGE) guidelines encouraging the use of endoscopy simulation training and its incorporation into training standards by a key accreditation organization. An EndoVators Summit, partially supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health, (NIH) was held at the ASGE Institute for Training and Technology from November 19 to 20, 2017. The summit brought together over 70 thought leaders in simulation research and simulator development and key decision makers from industry. Proceedings opened with a historical review of the role of simulation in medicine and an outline of priority areas related to the emerging role of simulation training within medicine broadly. Subsequent sessions addressed the summit's purposes: to review the current state of endoscopy simulation and the role it could play in endoscopic training, to define the role and value of simulators in the future of endoscopic training and to reach consensus regarding priority areas for simulation-related education and research and simulator development. This white paper provides an overview of the central points raised by presenters, synthesizes the discussions on the key issues under consideration, and outlines actionable items and/or areas of consensus reached by summit participants and society leadership pertinent to each session. The goal was to provide a working roadmap for the developers of simulators, the investigators who strive to define the optimal use of endoscopy-related simulation and assess its impact on educational outcomes and health care quality, and the educators who seek to enhance integration of simulation into training and practice.

ASGE review of adverse events in colonoscopy.

Colonoscopy is the most commonly performed endoscopic procedure and overall is considered a low-risk procedure. However, adverse events (AEs) related to this routinely performed procedure for screening, diagnostic, or therapeutic purposes are an important clinical consideration. The purpose of this document from the American Society for Gastrointestinal Endoscopy's Standards of Practice Committee is to provide an update on estimates of AEs related to colonoscopy in an evidence-based fashion. A systematic review and meta-analysis of population-based studies was conducted for the 3 most common and important serious AEs (bleeding, perforation, and mortality). In addition, this document includes an updated systematic review and meta-analysis of serious AEs (bleeding and perforation) related to EMR and endoscopic submucosal dissection for large colon polyps. Finally, a narrative review of other colonoscopy-related serious AEs and those related to specific colonic interventions is included.

ASGE guideline on the role of endoscopy for bleeding from chronic radiation proctopathy.

Chronic radiation proctopathy is a common sequela of radiation therapy for malignancies in the pelvic region. A variety of medical and endoscopic therapies have been used for the management of bleeding from chronic radiation proctopathy. In this guideline, we reviewed the results of a systematic search of the literature from 1946 to 2017 to formulate clinical questions and recommendations on the role of endoscopy for bleeding from chronic radiation proctopathy. The following endoscopic modalities are discussed in our document: argon plasma coagulation, bipolar electrocoagulation, heater probe, radiofrequency ablation, and cryoablation. Most studies were small observational studies, and the evidence for effectiveness of endoscopic therapy for chronic radiation proctopathy was limited because of a lack of controlled trials and comparative studies. Despite this limitation, our systematic review found that argon plasma coagulation, bipolar electrocoagulation, heater probe, and radiofrequency ablation were effective in the treatment of rectal bleeding from chronic radiation proctopathy.

ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis.

Each year choledocholithiasis results in biliary obstruction, cholangitis, and pancreatitis in a significant number of patients. The primary treatment, ERCP, is minimally invasive but associated with adverse events in 6% to 15%. This American Society for Gastrointestinal Endoscopy (ASGE) Standard of Practice (SOP) Guideline provides evidence-based recommendations for the endoscopic evaluation and treatment of choledocholithiasis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework was used to rigorously review and synthesize the contemporary literature regarding the following topics: EUS versus MRCP for diagnosis, the role of early ERCP in gallstone pancreatitis, endoscopic papillary dilation after sphincterotomy versus sphincterotomy alone for large bile duct stones, and impact of ERCP-guided intraductal therapy for large and difficult choledocholithiasis. Comprehensive systematic reviews were also performed to assess the following: same-admission cholecystectomy for gallstone pancreatitis, clinical predictors of choledocholithiasis, optimal timing of ERCP vis-à-vis cholecystectomy, management of Mirizzi syndrome and hepatolithiasis, and biliary stent therapy for choledocholithiasis. Core clinical questions were derived using an iterative process by the ASGE SOP Committee. This body developed all recommendations founded on the certainty of the evidence, balance of risks and harms, consideration of stakeholder preferences, resource utilization, and cost-effectiveness.

IgG4-related disease and lymphocyte-variant hypereosinophilic syndrome: A comparative case series.

OBJECTIVE: To compare the clinical and laboratory features of IgG4-related disease (IgG4-RD) and lymphocyte-variant hypereosinophilic syndrome (L-HES), two rare diseases that often present with lymphadenopathy, gastrointestinal symptoms, eosinophilia, and elevated immunoglobulins/IgE. METHOD: Comparative case series of 31 patients with IgG4-RD and 13 patients with L-HES. RESULTS: Peripheral blood eosinophilia was present in eight of 31 patients with IgG4-RD compared to 13 of 13 patients with L-HES (median eosinophils 0.4 vs 7.0 giga/L, P=.001) and 12 of 20 patients with IgG4-RD had increased serum IgE compared to eight of 13 patients with L-HES, P=.930. Twenty-seven of 30 patients with IgG4-RD had elevated serum IgG4 compared to five of 12 patients with L-HES (median IgG4 9.6 g/L vs 0.80 g/L, P=.002). Flow cytometry demonstrated an aberrant T-cell phenotype in 7 of 23 patients with IgG4-RD and 13 of 13 patients with L-HES (P<.001). T-cell clonality by PCR was positive in 12 of 23 patients with IgG4-RD vs 10 of 13 patients with L-HES (P=.143). Patients in both groups received corticosteroids as first-line therapy. For refractory disease in IgG4-RD, rituximab was the most common steroid-sparing agent, whereas in L-HES, it was pegylated interferon-α-2a. CONCLUSION: The overlapping features of these two diseases with divergent treatment options demonstrate the importance of familiarity with both entities to optimize diagnosis and treatment.

New developments in small bowel enteroscopy.

PURPOSE OF REVIEW: Endoscopic technology has evolved such that device-assisted enteroscopes (DAEs) are readily available and utilized to diagnose and treat patients with small bowel disease. In this review, we briefly discuss the DAE platforms and the expanding role for small bowel enteroscopy. RECENT FINDINGS: The indications for small bowel endoscopy are rapidly increasing with new diagnostic and therapeutic maneuvers that are allowing patients to obtain treatments that would have otherwise required more invasive or higher risk procedures. The evolving utilization of DAE tools in patients with altered gastrointestinal anatomy and otherwise palliative conditions is allowing for more aggressive and therapeutic choices for patients who would otherwise have limited options. SUMMARY: There are currently four different platforms for small bowel endoscopy each with different operational characteristics. The literature comparing double-balloon and single-balloon enteroscopy is relatively established, but there are still limited data evaluating the role of the two newer platforms (spiral and on-demand enteroscopy) in diagnostic and therapeutic small bowel endoscopy - a reflection of the potential and vast opportunities that are available in the field of small bowel enteroscopy.

Choledochal or pancreatic cyst? Role of endoscopic ultrasound as an adjunct for diagnosis: a case series.

BACKGROUND: Choledochal cysts (CC) are a cystic dilation of the intra- or extrahepatic biliary tree. They are rare, and are associated with a risk of malignant transformation. Due to the close proximity to the pancreas, Type II CC, in which a diverticular outpouching is connected to the extrahepatic bile duct via a narrow stalk, can be difficult to differentiate from pancreatic cysts. The aim of this study was to determine the role of endoscopic ultrasound (EUS) in the diagnosis of Type II CC. METHODS: A retrospective review of all patients seen in the Multidisciplinary Pancreatic Cyst Clinic at Johns Hopkins Hospital from November 2010 to March 2014 was performed to identify patients classified as having Type II CC on computed tomography (CT) or magnetic resonance imaging (MRI) who also underwent EUS. Patient demographics, clinical presentation, imaging, and follow-up were recorded. RESULTS: Four female patients with median age of 52 years, three of whom were identified as having Type II CC and one as equivocal for CC on MRI, and two as having Type II CC, one equivocal for CC and one as branch-duct intraductal papillary mucinous neoplasm on CT. On EUS, no communication was seen in any cases between the CC and common bile duct. EUS-guided fluid aspiration from each cyst demonstrated clear fluid with undetectable bilirubin and either elevated CEA or amylase confirming the diagnosis of pancreatic cyst. CONCLUSIONS: EUS is a useful tool for the differentiation of equivocal cases of CC. It can show a very small separation as little as 1 mm between two structures, and cyst fluid analysis can be performed and used to further differentiate between biliary cysts and other cystic structures.

Liver transplant patients have a risk of progression similar to that of sporadic patients with branch duct intraductal papillary mucinous neoplasms.

Intraductal papillary mucinous neoplasms (IPMNs) have malignant potential and can progress from low- to high-grade dysplasia to invasive adenocarcinoma. The management of patients with IPMNs is dependent on their risk of malignant progression, with surgical resection recommended for patients with branch-duct IPMN (BD-IPMN) who develop high-risk features. There is increasing evidence that liver transplant (LT) patients are at increased risk of extrahepatic malignancy. However, there are few data regarding the risk of progression of BD-IPMNs in LT recipients. The aim of this study was to determine whether LT recipients with BD-IPMNs are at higher risk of developing high-risk features than patients with BD-IPMNs who did not receive a transplant. Consecutive patients who underwent an LT with BD-IPMNs were included. Patients with BD-IPMNs with no history of immunosuppression were used as controls. Progression of the BD-IPMNs was defined as development of a high-risk feature (jaundice, dilated main pancreatic duct, mural nodule, cytology suspicious or diagnostic for malignancy, cyst diameter ≥3 cm). Twenty-three LT patients with BD-IPMN were compared with 274 control patients. The median length of follow-up was 53.7 and 24.0 months in LT and control groups, respectively. Four (17.4%) LT patients and 45 (16.4%) controls developed high-risk features (P = 0.99). In multivariate analysis, progression of BD-IPMNs was associated with age at diagnosis but not with LT. There was no statistically significant difference in the risk of developing high-risk features between the LT and the control groups.