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 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 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 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.

Intraportal Islet Autotransplantation Independently Improves Quality of Life After Total Pancreatectomy in Patients With Chronic Refractory Pancreatitis.

OBJECTIVE: To determine if islet autotransplantation (IAT) independently improves the quality of life (QoL) in patients after total pancreatectomy and islet autotransplantation (TP-IAT). BACKGROUND: TP-IAT is increasingly being used for intractable chronic pancreatitis. However, the impact of IAT on long-term islet function and QoL is unclear. METHODS: TP-IAT patients at our center >1 year after TP-IAT with ≥1 Short Form-36 QoL measure were included. Patients were classified as insulin-independent or insulin-dependent, and as having islet graft function or failure by C-peptide. The associations of insulin use and islet graft function with QoL measures were analyzed by using a linear mixed model, accounting for time since transplant and within-person correlation. RESULTS: Among 817 islet autograft recipients, 564 patients [median (interquartile range) age: 34 (20, 45) years, 71% female] and 2161 total QoL surveys were included. QoL data were available for >5 years after TP-IAT for 42.7% and for >10 years for 17.3%. Insulin-independent patients exhibited higher QoL in 7 of 8 subscale domains and for Physical Component Summary and Mental Component Summary scores ( P <0.05 for all). Physical Component Summary was 2.91 (SE=0.57) higher in insulin-independent patients ( P <0.001). No differences in QoL were observed between those with and without graft function, but islet graft failure was rare (15% of patients). However, glycosylated hemoglobin was much higher with islet graft failure. CONCLUSIONS: QoL is significantly improved when insulin independence is present, and glycosylated hemoglobin is lower with a functioning islet graft. These data support offering IAT, rather than just performing total pancreatectomy and treating with exogenous insulin.

Predicting need for intervention in acute necrotizing pancreatitis following discharge- A single center experience in 525 patients.

BACKGROUND AND AIMS: The clinical course of necrotizing pancreatitis (NP) is variable and unpredictable, with some patients managed conservatively, but a significant proportion become symptomatic and needing intervention for drainage and/or necrosectomy. The aim of this study was to identify patients based on baseline clinical and imaging metrics who will likely need intervention and therefore closer follow-up. METHODS: All NP patients managed in our institution between 2010 and 2019 were identified from a prospective database and those who did not undergo intervention during initial hospitalization were followed longitudinally post discharge until clinical and imaging resolution of necrosis. Patients were categorized into a conservative arm or intervention arm (endoscopic/percutaneous/surgical drainage and/or necrosectomy) for criteria defined according to IAP/APA guidelines. Clinical and imaging characteristics during initial presentation were analyzed between the two groups to identify independent predictors for eventual intervention using multivariable logistic regression. A nomogram was designed based on factors that were significant as defined by P value < 0.05. RESULTS: Among 525 patients, 340 who did not meet criteria for intervention during initial admission were included for study and followed for an average 7.4 ± 11.3 months. 140 were managed conservatively and 200 needed intervention (168 within 6 months and 32 after 6 months). Independent predictors of need for eventual intervention were white race [OR 3.43 (1.11-10.62)], transferred status [OR 3.37 (1.81-6.27)], and need for TPN [OR 6.86 (1.63-28.9)], necrotic collection greater than 6 cm [OR 8.66 (4.10-18.32)] and necrotic collection with greater than 75% encapsulation [OR 41.3 (8.29-205.5)]. A prediction model incorporating these factors demonstrated an area under the curve of 0.88. CONCLUSIONS: Majority of NP patients do not need intervention during initial admission but may require drainage/necrosectomy mostly in the first 6 months following discharge. Need for subsequent intervention can be accurately predicted by a combination of clinical and imaging features on index admission.

Visceral artery pseudoaneurysms in necrotizing pancreatitis: risk of early bleeding with lumen-apposing metal stents.

BACKGROUND AND AIMS: Visceral artery pseudoaneurysm (PSA) in necrotizing pancreatitis (NP) is associated with significant morbidity and mortality. This study aimed to evaluate the incidence, clinical presentation, management, and outcomes of PSA in NP. METHODS: All NP patients managed at our institution between 2010 and 2020 were retrospectively reviewed from a prospectively maintained database for PSA. Demographics, clinical presentation, method of diagnosis, management, and outcomes were collected. RESULTS: Thirty-nine of 607 patients (6.4%) with NP had a confirmed diagnosis of PSA. Demographics, presence of infected necrosis, development of organ failure(s), and severity of disease were similar between PSA and no PSA. Endoscopic and percutaneous drainages for walled-off necrosis (WON) were more common in the PSA group. Seven patients developed PSA without requiring any intervention for WON, and 17 patients (43.6%) had lumen-apposing metal stents (LAMSs) placed before PSA diagnosis. The time from NP diagnosis to PSA diagnosis was shorter in these patients (n = 17) compared with the remaining patients (n=22; 47 days [interquartile range {IQR}: 17-85] vs 109 days [IQR: 61-180.5, P=0.009]). In addition, 7 of 11 patients (63.6%) with early PSA (defined by <3 weeks from index cystgastrostomy/cystduodenostomy) had an indwelling LAMS at the time of the PSA diagnosis. Seventy-seven percent of patients presented with anemia, 74.3% with GI bleeding, and 30% with hemorrhagic shock. CT was diagnostic for PSA in 83.9% with a false-negative rate of 16.1%. Splenic (50%) and gastroduodenal (28%) arteries were the most common arteries involved by PSA. Angiography and embolization for PSA were successful in 33 of 35 patients. In-hospital mortality was observed in 9 patients (23.1%). CONCLUSIONS: Although visceral artery PSA affects a small percentage of NP patients, it is associated with significant morbidity and mortality. In addition, bleeding from PSA induced by erosion of LAMSs may occur in the first 2 weeks, prompting individualization of removal intervals.

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.

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.

Prediction of thirty-day morbidity and mortality after laparoscopic sleeve gastrectomy: data from an artificial neural network.

BACKGROUND: Multiple patient factors may convey increased risk of 30-day morbidity and mortality after laparoscopic vertical sleeve gastrectomy (LVSG). Assessing the likelihood of short-term morbidity is useful for both the bariatric surgeon and patient. Artificial neural networks (ANN) are computational algorithms that use pattern recognition to predict outcomes, providing a potentially more accurate and dynamic model relative to traditional multiple regression. Using a comprehensive national database, this study aims to use an ANN to optimize the prediction of the composite endpoint of 30-day readmission, reoperation, reintervention, or mortality, after LVSG. METHODS: A cohort of 101,721 LVSG patients was considered for analysis from the 2016 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program national dataset. Select patient factors were chosen a priori as simple, pertinent and easily obtainable, and their association with the 30-day endpoint was assessed. Those factors with a significant association on both bivariate and multivariate nominal logistic regression analysis were incorporated into a back-propagation ANN with three nodes each assigned a training value of 0.333, with k-fold internal validation. Logistic regression and ANN models were compared using area under receiver-operating characteristic curves (AUROC). RESULTS: Upon bivariate analysis, factors associated with 30-day complications were older age (P = 0.03), non-white race, higher initial body mass index, severe hypertension, diabetes mellitus, non-independent functional status, and previous foregut/bariatric surgery (all P < 0.001). These factors remained significant upon nominal logistic regression analysis (n = 100,791, P < 0.001, r2= 0.008, AUROC = 0.572). Upon ANN analysis, the training set (80% of patients) was more accurate than logistic regression (n = 80,633, r2= 0.011, AUROC = 0.581), and it was confirmed by the validation set (n = 20,158, r2= 0.012, AUROC = 0.585). CONCLUSIONS: This study identifies a panel of simple and easily obtainable preoperative patient factors that may portend increased morbidity after LSG. Using an ANN model, prediction of these events can be optimized relative to standard logistic regression modeling.

Single-stage management of choledocholithiasis: intraoperative ERCP versus laparoscopic common bile duct exploration.

BACKGROUND: Laparoscopic cholecystectomy (LC) is the criterion standard for treating patients with symptomatic gallstone disease; however, the optimal technique for extracting common bile duct stones remains unclear. Recent studies have noted improved outcomes with single-stage techniques, such as intraoperative endoscopic retrograde cholangiopancreatography (iERCP) and laparoscopic common bile duct exploration (LCBDE); however only few studies have directly compared those two single-stage techniques. OBJECTIVES: Using the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database, we retrospectively analyzed the postoperative outcomes of all patients who underwent single-stage LC for choledocholithiasis from 2005 to 2017. Using Current Procedural Terminology (CPT) codes, as well as International Classification of Diseases, Ninth Revision (ICD-9) and 10th Revision (ICD-10) codes, we stratified patients into two cohorts: those who underwent iERCP and LCBDE. Applying univariate techniques, we evaluated baseline characteristics and postoperative outcomes for both cohorts. Our primary outcomes of interest were 30-day morbidity and 30-day mortality; our secondary outcomes included rates of reoperation, readmission, operative time, and hospital length of stay. RESULTS: Of the 1814 single-stage LC patients during our 13-year study period, 1185 (65.3%) underwent LCBDE; 629 (34.6%) underwent iERCP. Our univariate analysis showed that the two cohorts were homogeneous in terms of baseline characteristics, including demographics, preoperative comorbidities, laboratory values, and American Society of Anesthesiologists (ASA) scores. 30-day postoperative morbidity (including infectious and noninfectious complications) and overall mortality between groups were low and comparable. The mean operative time was slightly longer with LCBDE (125.1 ± 62.0 min) than iERCP (113.5 ± 65.2 min; P < 0.001), however the mean hospital length of stay, readmission rate, and reoperation rate were similar. CONCLUSION: We found that both iERCP and LCBDE resulted in low, comparable rates of morbidity and mortality. Centers with readily available endoscopic expertise might favor iERCP for its ease of access and shorter operative time. However, LCBDE remains an appropriate technique for patients with choledocholithiasis, especially when immediate endoscopic intervention is unavailable.

Evolution of Endoscopic Bariatric Devices: From Development to Practice.

OBJECTIVES: To familiarize medical providers with the Food and Drug Administration approval process for antiobesity devices and to provide a brief overview of current and promising endoscopy-based bariatric devices. METHODS: Literature review of published scholarly articles. RESULTS: There has been a rapid development of novel endoscopic bariatric therapies in recent years, resulting in the approval of multiple devices. Several promising endoscopic strategies are currently under investigation and review. The Food and Drug Administration has laid down an objective-tiered model to review antiobesity device applications. DISCUSSION: Endoscopic bariatric devices provide a new and promising paradigm in obesity management both as first-line therapy and as adjunctive treatment to medical and surgical strategies. Physicians who plan to offer endoscopic bariatric therapy in their practice need appropriate understanding of the regulatory processes involved in the development and approval of such devices.

Early (<4 Weeks) Versus Standard (≥ 4 Weeks) Endoscopically Centered Step-Up Interventions for Necrotizing Pancreatitis.

OBJECTIVES: Current guidelines for necrotizing pancreatitis (NP) recommend delay in drainage ± necrosectomy until 4 or more weeks after initial presentation to allow collections to wall off. However, evidence of infection with clinical deterioration despite maximum support may mandate earlier (<4 weeks) intervention. There are concerns, but scant data regarding risk of complications and outcomes with early endoscopic intervention. Our aim was to compare the results of an endoscopic centered step-up approach to NP when initiated before versus 4 or more weeks. METHODS: All patients undergoing intervention for NP were managed using an endoscopically centered step-up approach, with transluminal drainage whenever feasible, ±necrosectomy, and/or percutaneous catheter drainage as needed, with surgery only for failures. Interventions were categorized as early or standard based on timing of intervention (<4 weeks or ≥ 4 weeks from onset of pancreatitis). Demographic data, indications and timing for interventions, number and type of intervention, mortality and morbidity (length of stay in hospital and ICU) and complications were compared. RESULTS: Of 305 patients with collections associated with NP, 193 (63%) (median age-52 years) required intervention, performed by a step-up approach. Of the 193 patients, 76 patients underwent early and 117 patients standard intervention. 144 (75%) interventions included endoscopic drainage ± necrosectomy. As compared with standard intervention, early intervention was more often performed for infection (91% vs. 39%, p < 0.05), more associated with acute kidney injury (43% vs. 32%, p = 0.09), respiratory failure (41% vs. 22%, p = 0.005), and shock (13% vs. 4%, p < 0.05). Organ failure improved significantly after intervention in both groups. There was a significant difference in mortality (13% vs. 4%, p = 0.02) and need for rescue open necrosectomy (7% vs. 1%, p = 0.03) between groups. Patients undergoing early intervention had increased median hospital (37 days vs. 26 days, p = 0.01) and ICU stay (median 2.5 days vs. 0 days, p = 0.001). There was no difference in complications. CONCLUSIONS: When using an endoscopically centered step-up strategy in necrotizing pancreatitis, early (<4 weeks) interventions were more often performed for infection and organ failure, with no increase in complications, similar improvement in organ failure, slightly increased need for surgery, and relatively low mortality. Early endoscopic drainage ± necrosectomy should be considered when there is a strong indication for intervention.

Advanced ERCP techniques for the extraction of complex biliary stones: a single referral center's 12-year experience.

OBJECTIVES: Advanced ERCP techniques (AETs) for difficult biliary stones include peroral cholangioscopy (POC) with electrohydraulic/laser lithotripsy (EHL/LL), endoscopic papillary large balloon dilation (EPLBD) and mechanical lithotripsy (ML). We assess the efficacy of AETs. METHODS: A retrospective query for AETs. PRIMARY OUTCOME: Complete duct clearance. Secondary outcome: Complete duct clearance by technique. Statistical Analysis version 9.3 (SAS Inc., Cary, NC). RESULTS: From 1/00 to 10/12, 349 patients were identified of which 222 (80% had prior ERCPs) had AETs. 211 with sufficient follow-up underwent 295 ERCPs; 280 of which were AET's. Index AETs: POC with EHL/LL (n = 46/211, 22%), ML (n = 84/211, 40%), EPLBD with mean balloon size of 11.5 ± 1.7 mm (n = 39/211, 18%) and combination AETs (n = 42/211, 20%). Stone characteristics: 76% had ≥1 stone, 81% extrahepatic and 32% had strictures. Number of stones (mean 2.5 and range 1-20) did not differ among groups. EPLBD had higher percentage (95%) of extrahepatic stones (p = .0003). The 'Combination' and 'POC' groups had larger stones (mean 17.7 mm ±6.4 and 16.8 mm ±6.1, respectively; p < .001). Complete clearance: 209/211 (99%) at index AET 167/211 (79%) or after mean of 2.5 ± 0.7 AETs in 42/211 (20%). Partial clearance: 2/211 (1%). Clearance at index AETs was higher with EPLBD (90%, p = .014). Adverse Events: 7/280 (2.5%). CONCLUSIONS: AETs achieved clearance in 99%. EPLBD had higher clearance at index AET likely owing to higher extrahepatic stones. Larger stones, but not number, were associated with increased combination AETs and total ERCPs.