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We evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection.Randomized trials have shown similar efficacy of endoscopic treatment compared to surgery for infected WON.We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound (EUS)-guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥ 6 cm in diameter with 30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events (SAEs).Forty consecutive patients were enrolled September 2018 - March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. SAEs occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths.EUS-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.gov no: NCT03525808.

The optimal therapeutic approach for walled-off necrosis (WON) is not fully understood, given the lack of a validated classification system. We propose a novel and robust classification system based on radiologic and clinical factors to standardize the nomenclature, provide a framework to guide comparative effectiveness trials, and inform the optimal WON interventional approach.This was a retrospective analysis of patients who underwent endoscopic management of WON by lumen-apposing metal stent placement at a tertiary referral center. Patients were classified according to the proposed QNI classification system: quadrant ("Q"), represented an abdominal quadrant distribution; necrosis ("N"), denoted by the percentage of necrosis of WON; and infection ("I"), denoted as positive blood culture and/or systemic inflammatory response syndrome reaction with a positive WON culture. Two blinded reviewers classified all patients according to the QNI system. Patients were then divided into 2 groups: those with a lower QNI stratification (≤2 quadrants and ≤30% necrosis; group 1) and those with a higher stratification (≥3 quadrants, 2 quadrants with ≥30% necrosis, or 1 quadrant with60% necrosis and infection; group 2). The primary outcome was mean time to WON resolution. Secondary procedural and clinical outcomes between the groups were compared.Seventy-one patients (75% men) were included and stratified by the QNI classification; group 1 comprised 17 patients and group 2, 54 patients. Patients in group 2 had a higher number of necrosectomies, longer hospital stays, and more readmissions. The mean time to resolution was longer in group 2 than in group 1 (79.6 ± 7.76 days vs 48.4 ± 9.22 days, P = .02). The mortality rate was higher in group 2 (15% vs 0%, P = .18).Despite the heterogeneous nature of WON in severe acute pancreatitis, a proposed QNI system may provide a standardized framework for WON classification to inform clinical trials, risk-stratify the disease course, and potentially inform an optimal management approach.

Endoscopic ultrasound (EUS)-guided main pancreatic duct (PD) access may be used when conventional endoscopic retrograde cholangiopancreatography (ERCP) techniques fail. The use of a percutaneous transluminal angioplasty balloon (PTAB), originally developed for vascular interventions, can be used to facilitate transmural (To describe the technique, efficacy, and safety of PTABs for EUS-guided PD interventions.Patients who underwent EUS with use of a PTAB from March 2011 to August 2021 were retrospectively identified from a tertiary care medical center supply database. PTABs included 3-4 French angioplasty catheters with 3-4 mm balloons designed to use over a 0.018-inch guidewire. The primary outcome was technical success. Secondary outcomes included incidence of adverse events (AEs) and need for early reintervention.A total of 23 patients were identified (48% female, mean age 55.8 years). Chronic pancreatitis was the underlying etiology in 13 (56.5%) patients, surgically altered anatomy (SAA) with stricture in 7 (30.4%), and SAA with post-operative leak in 3 (13.0%). Technical success was achieved in 20 (87%) cases. Overall AE rate was 26% (EUS-guided use of PTABs for PD access and/or stricture management is feasible with an acceptable safety profile and can be considered in patients when conventional ERCP cannulation fails.

Background and Aims Closure of endoscopic resection defects can be achieved with through-the-scope clips, over-the-scope clips or endoscopic suturing. However, these devices are often limited by their inability to close large, irregular, and difficult to reach defects. Thus, we aimed to assess the feasibility and safety of the novel through-the-scope suture-based closure system that was developed to overcome these limitations. Methods This is a retrospective multicenter study involving 8 centers in the United States. Primary outcomes included feasibility and safety of early use of the device. Secondary outcomes included assessment of need for additional closure devices, prolonged procedure time, and technical feasibility of performing the procedure with an alternative device(s). Results A total of 93 patients (48.4% female) with mean age 63.6 ± 13.1 years were included. Technical success was achieved in 83 patients (89.2%) and supplemental closure was required in 24.7% (n=23) of patients with a mean defect size of 41.6 ± 19.4 mm. Closure with an alternative device was determined to be impossible in 24.7% of patients due to location, size, or shape of the defect. The use of the tack and suture device prolonged the procedure in 8.6% of the cases but was considered acceptable. Adverse events occurred in 2 patients (2.2%) over a duration of follow-up of 34 days (interquartile range: 13-93.5 days) and were mild and moderate in severity. No serious adverse events or procedure-related deaths occurred. Conclusions The novel endoscopic through-the-scope tack and suture system is safe, efficient, and permits closure of large, and irregularly shaped defects that were not possible with predicate devices.

Background & aims Increased intrapancreatic fat is associated with pancreatic diseases; however, there are no established objective diagnostic criteria for fatty pancreas. On non-contrast computed tomography (CT), adipose tissue shows negative Hounsfield Unit (HU) attenuations (−150 to −30 HU). Using whole organ segmentation on non-contrast CT, we aimed to describe whole gland pancreatic attenuation and establish 5th and 10th percentile thresholds across a spectrum of age and sex. Subsequently, we aimed to evaluate the association between low pancreatic HU and risk of pancreatic ductal adenocarcinoma (PDAC). Methods The whole pancreas was segmented in 19,456 images from 469 non-contrast CT scans. A convolutional neural network was trained to assist pancreas segmentation. Mean pancreatic HU, volume, and body composition metrics were calculated. The lower 5th and 10th percentile for mean pancreatic HU were identified, examining the association with age and sex. Pre-diagnostic CT scans from patients who later developed PDAC were compared to cancer-free controls. Results Less than 5th percentile mean pancreatic HU was significantly associated with increase in BMI (OR 1.07; 1.03–1.11), visceral fat (OR 1.37; 1.15–1.64), total abdominal fat (OR 1.12; 1.03–1.22), and diabetes mellitus type 1 (OR 6.76; 1.68–27.28). Compared to controls, pre-diagnostic scans in PDAC cases had lower mean whole gland pancreatic HU (−0.2 vs 7.8, p = 0.026). Conclusion In this study, we report age and sex-specific distribution of pancreatic whole-gland CT attenuation. Compared to controls, mean whole gland pancreatic HU is significantly lower in the pre-diagnostic phase of PDAC.

Background & Aims: Duodenoscope-associated transmission of infections has raised questions about efficacy of endoscope reprocessing using high-level disinfection (HLD). Although ethylene oxide (ETO) gas sterilization is effective in eradicating microbes, the impact of ETO on endoscopic ultrasound (EUS) imaging equipment remains unknown. In this study, we aimed to compare the changes in EUS image quality associated with HLD vs HLD followed by ETO sterilization. Methods: Four new EUS instruments were assigned to 2 groups: Group 1 (HLD) and Group 2 (HLD + ETO). The echoendoscopes were assessed at baseline, monthly for 6 months, and once every 3 to 4 months thereafter, for a total of 12 time points. At each time point, review of EUS video and still image quality was performed by an expert panel of reviewers along with phantom-based objective testing. Linear mixed effects models were used to assess whether the modality of reprocessing impacted image and video quality. Results: For clinical testing, mixed linear models showed minimal quantitative differences in linear analog score (P =. 04; estimated change, 3.12; scale, 0–100) and overall image quality value (P =. 007; estimated change, −0.12; scale, 1–5) favoring ETO but not for rank value (P =. 06). On phantom testing, maximum depth of penetration was lower for ETO endoscopes (P

Background and Aims Endoscopic management of acute cholecystitis has expanded in patients who are considered nonoperative candidates. Traditionally managed with percutaneous cholecystostomy (PC), improvement in techniques and devices has led to increased use of endoscopic methods for gallbladder drainage. This document reviews technical aspects of endoscopic transpapillary gallbladder drainage (ET-GBD) and EUS-guided GBD (EUS-GBD) as well as their respective technical/clinical success and adverse event rates. Available comparative data are also reviewed among nonsurgical gallbladder drainage techniques (PC, ET-GBD, and EUS-GBD). Methods The MEDLINE database was searched through March 2021 for relevant articles by using keywords including “acute cholecystitis,” “interventional EUS,” “percutaneous cholecystostomy,” “transpapillary gallbladder drainage,” “EUS-guided gallbladder drainage,” “lumen-apposing metal stent,” “gallbladder stenting,” and “endoscopic gallbladder drainage.” The manuscript was drafted by 2 authors and reviewed by members of the American Society for Gastrointestinal Endoscopy Technology Committee and subsequently by the American Society for Gastrointestinal Endoscopy Governing Board. Results Multiple studies have demonstrated acceptable outcomes comparing PC and both endoscopic gallbladder drainage techniques, ET-GBD and EUS-GBD. Published data suggest that endoscopic gallbladder drainage techniques may be associated with lower rates of adverse events and improved quality of life. However, there are important clinical considerations for choosing among these treatment options, requiring a multidisciplinary and collaborative approach to therapeutic decision-making in these patients. Conclusions The implementation of EUS-GBD and ET-GBD in high-risk surgical patients with acute cholecystitis may result in favorable outcomes when compared with PC. Further improvements in techniques and training should lead to more widespread acceptance and dissemination of these treatment options.

Background and Aims Esophageal function testing is an integral component of the evaluation of refractory GERD and esophageal motility disorders. This review summarizes the current technologies available for esophageal function testing, including the functional luminal imaging probe (FLIP), high-resolution esophageal manometry (HRM), and multichannel intraluminal impedance (MII) and pH monitoring. Methods We performed a MEDLINE, PubMed, and MAUDE database literature search to identify pertinent clinical studies through March 2021 using the following key words: esophageal manometry, HRM, esophageal impedance, FLIP, MII, and esophageal pH testing. Technical data were gathered from traditional and web-based publications, proprietary publications, and informal communications with pertinent vendors. The report was drafted, reviewed, and edited by the American Society for Gastrointestinal Endoscopy Technology Committee and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy. Results FLIP is a high-resolution impedance planimetry system used for pressure and dimension measurement in the esophagus, pylorus, and anal sphincter. FLIP provides complementary information to HRM for esophageal motility disorders, especially achalasia. The Chicago classification, based on HRM data, is a widely adopted algorithmic scheme used to diagnose esophageal motility disorders. MII detects intraluminal bolus movement and, combined with pH measurement or manometry, provides information on acid and non-acid gastroesophageal reflux and bolus transit in patients with refractory GERD and for preoperative evaluation for anti-reflux procedures. Conclusions Esophageal function testing techniques (FLIP, HRM, and MII-pH) have diagnostic and prognostic value in the evaluation of esophageal motility disorders and refractory GERD. Newer technologies and classification systems have enabled an increased understanding of these diseases., Video Video 1 Endoscopic video of ENDOFLIP procedure.

Background and Aims Lumen-apposing metal stents (LAMSs) are a novel class of devices that have expanded the spectrum of endoscopic GI interventions. LAMSs with their dumbbell configuration, short saddle length, and large inner luminal diameter provide favorable stent characteristics to facilitate anastomosis formation between the gut lumen and adjacent structures. Methods The MEDLINE database was searched through April 2021 for articles related to LAMSs by using additional relevant keywords such as “walled-off pancreatic necrosis,” “pseudocysts,” “pancreatic fluid collection,” “cholecystitis,” “gastroenterostomy,” in addition to “endoscopic treatment” and “endoscopic management,” among others. Results This technology review describes the full spectrum of LAMS designs and delivery systems, techniques for deployment, procedural outcomes, safety, training issues, and financial considerations. Conclusions Although LAMSs were initially introduced for drainage of pancreatic pseudocysts and walled-off necrosis, the versatility of these devices has led to a variety of off-label uses including gallbladder drainage, enteric bypass with the creation of gastroenterostomies, and treatment of luminal GI strictures.

Gastrointestinal (GI) endoscopy has witnessed a Cambrian explosion of techniques, indications, and expanding target populations. GI endoscopy encompasses traditional domains that include preventive measures, palliation, as alternative therapies in patients with prohibitive risks of more invasive procedures, and indicated primary treatments. But, it has expanded to include therapeutic and diagnostic interventional endosonography, luminal endoscopic resection, third space endotherapy, endohepatology, and endobariatrics. The lines between surgery and endoscopy are blurred on many occasions within this paradigm. Moreover, patients with high degrees of co-morbidity and complex physiology require more nuanced peri-endoscopic management. The rising demand for endoscopy services has resulted in the development of endoscopy referral centers that offer these invasive procedures as directly booked referrals for regional and rural patients. This further necessitates specialized programs to ensure appropriate evaluation, risk stratification, and optimization for safe sedation and general anesthesia if needed. This landscape is conducive to the organic evolution of endo-anesthesia to meet the needs of these focused and evolving practices. In this primer, we delineate important aspects of endo-anesthesia care and provide relevant clinical and logistical considerations pertaining to the breadth of procedures.

Background and Aims Zenker’s diverticulum (ZD) has traditionally been treated with open surgery or rigid endoscopy. With the advances in endoscopy, alternative flexible endoscopic treatments have been developed. Methods This document reviews current endoscopic techniques and devices used to treat ZD. Results The endoscopic techniques may be categorized as the traditional flexible endoscopic septal division and the more recent submucosal tunneling endoscopic septum division, also known as peroral endoscopic myotomy for ZD. This document also addresses clinical outcomes, safety, and financial considerations. Conclusions Flexible endoscopic approaches treat symptomatic ZD with results that are favorable compared with traditional open surgical or rigid endoscopic alternatives.

Background and Aims: Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience. Methods: Fourteen “expert” (>2000 lifetime ERCPs) and 5 “less-expert” endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events. Results: Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P =.131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P =.999), median ERCP completion time (25.0 vs 28.5 minutes, P =.130), mean cannulation attempts (2.8 vs 2.8, P =.954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P =.840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P Conclusions: In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.)

Background and Aims Multidrug-resistant infectious outbreaks associated with duodenoscopes have been documented internationally. Single-use duodenoscopes, disposable distal ends, or distal end cap sealants could eliminate or reduce exogenous patient-to-patient infection associated with ERCP. Methods This document reviews technologies that have been developed to help reduce or eliminate exogenous infections because of duodenoscopes. Results Four duodenoscopes with disposable end caps, 1 end sheath, and 2 disposable duodenoscopes are reviewed in this document. The evidence regarding their efficacy in procedural success rates, reduction of duodenoscope bacterial contamination, clinical outcomes associated with these devices, safety, and the financial considerations are discussed. Conclusions Several technologies discussed in this document are anticipated to eliminate or reduce exogenous infections during endoscopy requiring a duodenoscope. Although disposable duodenoscopes can eliminate exogenous ERCP-related risk of infection, data regarding effectiveness are needed outside of expert centers. Additionally, with more widespread adoption of these new technologies, more data regarding functionality, medical economics, and environmental impact will accrue. Disposable distal end caps facilitate duodenoscope reprocessing; postmarketing surveillance culture studies and real-life patient infection analyses are important areas of future research.

Background and aims Advanced endoscopy (AE) fellowship interviews during the 2020 application cycle were held virtually due to COVID-19 pandemic. This study aimed to characterize the application experience with virtual interviews. Methods Applicants and programs participating in the 2020 AE fellowship match were prospectively sent separate 17-question surveys. Responses were collected using Research Electronic Data Capture. Results In total, 63/104 applicants (60.6%) matched and 64/71 (90.1%) positions filled within the match. The survey was completed by 37/87 (42.5%) applicants and 71 interviewers from 43/65 (66.2%) participating programs. Most applicants (64.7%) preferred a 1:1 applicant:faculty ratio and a 20-minute interview (73.5%), which was used by programs 50.7% and 47.8%, respectively. The majority of applicants (82.4%) and interviewers (76.8%) reported overall satisfaction with virtual interviews. The biggest limitations for applicants were getting a “feel” for the program and endoscopy unit. In the future, 41.2% of applicants preferred only virtual interviews compared to 7.2% of interviewers (P< 0.01). Conversely, 14.7% of applicants preferred only in-person interviews compared to 39.1% of interviewers (P= 0.01). Half of the interviewers (50.7%) would negatively view applicants who chose a virtual option over an in-person interview if both were offered. Conclusion The majority of AE fellowship applicants and programs reported overall satisfaction with virtual interviews during the COVID-19 pandemic. Given the potential benefits, virtual interviews may have an increasing role in future residency and fellowship applications. Programs that conduct virtual interviews need to be aware of its limitations and have measures to improve the applicant experience and mitigate potential biases of interviewers.

Background Most incidental gastric polyps identified during upper endoscopy are considered low-risk. However, current guidelines recommend sampling all gastric polyps for histopathologic analysis. We aimed to devise a simple narrow-band imaging (NBI) classification to reduce the need for routine biopsies of low-risk gastric polyps. Methods Pairs of NBI and white-light images were collected from 73 gastric polyps for which concurrent histopathologic diagnosis was available. A diagnostic accuracy cohort study was performed. Two blinded endoscopists independently analysed NBI features of each polyp for color, vessel pattern, surface pattern, and any combinations thereof to develop a classification scheme to differentiate low-risk polyps (fundic-gland or hyperplastic) from high-risk polyps (adenomatous or adenocarcinoma) and fundic-gland polyps (FGPs) from non-FGPs. Results An isolated lacy vessel pattern and a homogenous absence of surface pattern successfully differentiated low-risk from high-risk gastric polyps. Combining both descriptors into a single algorithm resulted in a negative predictive value (NPV) of 100% [95% confidence interval (CI): 100%–100%], positive predictive value (PPV) of 13.7% (95% CI: 2.6–24.8), sensitivity of 100% (95% CI: 100%–100%), and specificity of 53.7% (95% CI: 45.3%–62.0%) for high-risk polyps. This would reduce the number of polyps requiring biopsy by 50%, while still capturing all high-risk polyps. Regarding FGPs, using a rule not to biopsy polyps with isolated lacy vessels resulted in a 94.9% NPV (95% CI: 89.2%–100%), 63.2% PPV (95% CI: 47.2%–79.2%), 94.8% sensitivity (95% CI: 89.5%–100%), and 63.6% specificity (95% CI: 51.3%–76.0%) for non-FGPs. Conclusion In this derivation cohort study, NBI is helpful for differentiating between high-risk and low-risk gastric polyps, thereby reducing the need for routine sampling of low-risk polyps. These results need to be validated in a separate test population.

Background and Aims As the prevalence of obesity continues to rise, increasing numbers of patients undergo bariatric surgery. Management of adverse events of bariatric surgery may be challenging and often requires a multidisciplinary approach. Endoscopic intervention is often the first line of therapy for management of these adverse events. This document reviews technologies and techniques used for endoscopic management of adverse events of bariatric surgery, organized by surgery type. Methods The MEDLINE database was searched through May 2018 for articles related to endoscopic management of adverse events of bariatric interventions by using relevant keywords such as adverse events related to “gastric bypass,” “sleeve gastrectomy,” “laparoscopic adjustable banding,” and “vertical banded sleeve gastroplasty,” in addition to “endoscopic treatment” and “endoscopic management,” among others. Available data regarding efficacy, safety, and financial considerations are summarized. Results Common adverse events of bariatric surgery include anastomotic ulcers, luminal stenoses, fistulae/leaks, and inadequate initial weight loss or weight regain. Devices used for endoscopic management of bariatric surgical adverse events include balloon dilators (hydrostatic, pneumatic), mechanical closure devices (clips, endoscopic suturing system, endoscopic plication platform), luminal stents (covered esophageal stents, lumen-apposing metal stents, plastic stents), and thermal therapy (argon plasma coagulation, needle-knives), among others. Available data, composed mainly of case series and retrospective cohort studies, support the primary role of endoscopic management. Multiple procedures and techniques are often required to achieve clinical success, and existing management algorithms are evolving. Conclusions Endoscopy is a less invasive alternative for management of adverse events of bariatric surgery and for revisional procedures. Endoscopic procedures are frequently performed in the context of multidisciplinary management with bariatric surgeons and interventional radiologists. Treatment algorithms and standards of practice for endoscopic management will continue to be refined as new dedicated technology and data emerge.

Background and Aims Residual neoplasia after macroscopically complete EMR of large colon polyps has been reported in 10% to 32% of resections. Often, residual polyps at the site of prior polypectomy are fibrotic and nonlifting, making additional resection challenging. Methods This document reviews devices and methods for the endoscopic treatment of fibrotic and/or residual polyps. In addition, techniques reported to reduce the incidence of residual neoplasia after endoscopic resection are discussed. Results Descriptions of technologies and available outcomes data are summarized for argon plasma coagulation ablation, snare-tip coagulation, avulsion techniques, grasp-and-snare technique, EndoRotor endoscopic resection system, endoscopic full-thickness resection device, and salvage endoscopic submucosal dissection. Conclusions Several technologies and techniques discussed in this document may aid in the prevention and/or resection of fibrotic and nonlifting polyps.

BACKGROUND AND AIMS Presence of malignant regional lymph nodes (MRLNs) precludes curative oncological resection or liver transplantation for cholangiocarcinoma (CCA). Limited data support the utility of endoscopic ultrasound (EUS)/fine needle aspiration (FNA) for detection of MRLNs in extrahepatic CCA, but there are no data for its role in intrahepatic CCA (iCCA). The aim of this study is to evaluate the staging impact of EUS for CCA, including analysis by subtype. APPROACH AND RESULTS We identified consecutive patients with CCA who underwent EUS staging at a single tertiary care center from October 2014 to April 2018. Among this cohort, we abstracted clinical demographic, radiographical, procedural, cytopathological, and surgical data. STATA 15 software was used for comparative analysis calculations (StataCorp LP, College Station, TX). The study cohort included 157 patients; 24 (15%), 124 (79%), and 9 (6%) with intrahepatic, perihilar, and distal CCA, respectively. EUS was able to identify regional lymph nodes (RLNs) in a higher percentage of patients compared to cross-sectional imaging (86% vs. 47%; P