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SUMMARY: Nondysplastic Barrett's esophagus has a risk of progression to esophageal adenocarcinoma as low as 0.18–0.3% per person per year, and low-grade dysplasia as low as 0.5%. While adherence to guidelines and selection of management options varies, little is known about what modifies patient decision-making. This study aims to evaluate and identify factors that influence patient perceptions of risk and decisions about management. An independently developed and piloted survey was administered to patients at an academic hospital. Risk perception and desire for therapy were assessed using a standard reference gamble paradigm, and responses were stratified based on patient and disease characteristics. Data were analyzed with Student's t and chi-squared tests. A total of 42 of 50 patients with Barrett's esophagus and no prior endoscopic therapy participated (84% response; 76% nondysplastic Barrett's esophagus, 22% low-grade dysplasia, 2% indeterminate for dysplasia; mean age 61 years, 29% female). On average, patients perceived their risk of developing esophageal adenocarcinoma in the next year, 10 years and lifetime as 6, 14, and 19%, respectively. Nearly half viewed their lifetime risk of developing esophageal adenocarcinoma to be the same or higher than diabetes, heart disease, or colon cancer. Although 92% of patients felt surveillance beneficial, only 54% believed endoscopic therapy to be effective in most or all cases. As many as 83% of patients were willing to undergo endoscopic therapy with a hypothetical success rate as low as 70%, and a majority (64%) accepted complication rates up to 30%. Compared to patients with low risk perception of developing esophageal adenocarcinoma, those with high risk perception more often believed their risk for developing esophageal adenocarcinoma was greater than diabetes (p = 0.04) or colon cancer (p = 0.002). Those with lifetime low risk perception were less likely to accept modest complication rates (<10%) of therapy (P < 0.05). Age, gender, degree of dysplasia, lifetime endoscopies and duration of symptoms had no impact on perceived effectiveness of surveillance or therapy, and did not correlate with desire for treatment at varying levels of risk and effectiveness. Patients with Barrett's esophagus overestimate their risk of developing esophageal adenocarcinoma and will accept low success rates and high risk of complications to undergo endoscopic therapy. Baseline risk perception correlates with the desire for endoscopic therapy. [ABSTRACT FROM AUTHOR]

Background: Advantages of direct peroral cholangioscopy (DPOCS) by using an ultraslim endoscope include a single-operator platform, image quality equal to that of standard endoscopy, and separate water and air channels. However, DPOCS has significant limitations, including cumbersome biliary access, en-face position with the ampulla, and gastric looping of the endoscope. A newly designed anchoring balloon may overcome these challenges. Objective: To report the feasibility of DPOCS with the anchoring balloon. Design: Pilot study, porcine model. Setting: Animal resources center. Intervention: The anchoring balloon system developed by Cook Medical (Winston-Salem, NC) was used for DPOCS. Main Outcome Measurements: Primary: Feasibility of biliary access maintenance and intraductal mobility. Secondary: Feasibility of intraductal therapeutic procedures. Results: Four animal subjects underwent DPOCS with the anchoring balloon. Ductal access was achieved with sphincterotomy in 2 subjects and with a balloon sphincteroplasty in 2 subjects. Intraductal placement of the ultraslim endoscope was achieved in all biliary access attempts without balloon migration or deflation. Common bile duct, cystic duct, bifurcation, and main right and left duct direct visualization was achieved in all cases. Therapeutic interventions by DPOCS, including intraductal biopsy, balloon dilatation, and intraductal bilateral metal stent placement, were all completed successfully. Biliary perforation occurred in one case because of balloon overinflation and in a second case because of sphincterotomy. Limitations: Prototype study in an animal model and small study size. Conclusion: Our results show that the novel anchoring balloon system successfully and safely enables DPOCS for both diagnostic and therapeutic interventions. If corroborated in human trials, it could offer a new platform for biliary interventions. [ABSTRACT FROM AUTHOR]

BACKGROUND: Performance parameters for double-balloon enteroscopy (DBE) have not been described. OBJECTIVE: To determine the learning curve for DBE. DESIGN: Prospective cohort study. SETTING: Six U.S. tertiary centers. PATIENTS: A total of 188 subjects undergoing 237 DBE procedures; 130 (69%) with obscure GI bleeding. INTERVENTIONS: Performance parameters from each center's initial 10 cases were compared to the subsequent examinations. MAIN OUTCOME MEASUREMENTS: Exam duration, depth of insertion, and findings on DBE examination. RESULTS: DBE was introduced by mouth in 149 (63%) cases, by rectum in 77 (33%) cases, and through a stoma in 6 (2.5%) patients. The mean (+/-SD) duration was 109.1 +/- 44.6 minutes for the first 10 cases and 92.4 +/- 37.6 minutes for subsequent cases (P = .005) but did not change for rectal DBE procedures. There was no change in mean depth of insertion, but the mean fluoroscopy time declined significantly (P = .025). Diagnostic or therapeutic maneuvers were performed in 64% of cases; DBE led to a diagnosis in 81 (43%) patients. A total of 78% of patients had prior capsule endoscopy (CE) with significant agreement between DBE and CE (kappa = 0.74). One perforation occurred (0.4%). Per-rectal cases failed to reach the small bowel in 24 (31%) cases. LIMITATIONS: All patients did not undergo initial CE. The therapeutic DBE scope was not available for the initial 8 months of the study. CONCLUSIONS: There was a significant decline in overall procedural time and fluoroscopy time after the initial 10 DBE cases. There was no improvement in performance parameters when DBE was performed via the rectal approach despite increased, but limited, operator experience. [ABSTRACT FROM AUTHOR]

The article presents a case study of a 60-year-old man who underwent a hybrid endoscopic therapy for intramucosal Barrett's cancer. He had three subsequent sessions with focal endoscopic mucosal resection (EMR) of the lesions and radiofrequency ablation (RFA) of the Barrett's esophagus section. He developed a neosquamous epithelium without apparent Barrett's esophagus. An endoscopic ultrasound (EUS) showed a gastrohepatic lymph node diagnosed as metastatic adenocarcinoma with a squamous mucosa.

Background: Nivolumab 3 mg/kg every 2 weeks (Q2W) has shown benefit versus the standard of care in melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC). However, flat dosing is expected to shorten preparation time and improve ease of administration. With knowledge of nivolumab safety, efficacy, and pharmacokinetics across a wide dose range in body weight (BW) dosing, assessment of the benefit-risk profile of a 240-mg flat dose relative to the approved 3-mg/kg dose was approached by quantitative clinical pharmacology. Patients and methods: A flat dose of 240 mg was selected based on its equivalence to the 3-mg/kg dose at the median BW of ~80 kg in patients in the nivolumab program. The benefit-risk profile of nivolumab 240 mg was evaluated by comparing exposures at 3 mg/kg Q2W and 240mg Q2W across BW and tumor types; clinical safety at 3 mg/kg Q2W by BW and exposure quartiles in melanoma, NSCLC, and RCC; and safety and efficacy at 240mg Q2W relative to 3 mg/kg Q2W in melanoma, NSCLC, and RCC. Results: The median nivolumab exposure and its distribution at 240 mg Q2W were similar to 3 mg/kg Q2W in the simulated population. Safety analyses did not demonstrate a clinically meaningful relationship between BW or nivolumab exposure quartiles and frequency or severity of adverse events. The predicted safety and efficacy were similar across nivolumab exposure ranges achieved with 3 mg/kg Q2W or 240mg Q2W flat dose. Conclusion: Based on population pharmacokinetic modeling, established flat exposure-response relationships for efficacy and safety, and clinical safety, the benefit-risk profile of nivolumab 240 mg Q2W was comparable to 3 mg/kg Q2W. The quantitative clinical pharmacology approach provided evidence for regulatory decision-making on dose modification, obviating the need for an independent clinical study. [ABSTRACT FROM AUTHOR]

Background: Nivolumab has shown significant survival benefit and a favorable safety profile compared with dacarbazine chemotherapy among treatment-naïve patients with metastatic melanoma in the CheckMate 066 phase III study. Results from the health-related quality of life (HRQoL) analyses from CheckMate 066 are presented. Patients and methods: HRQoL was evaluated at baseline and every 6 weeks while on treatment using the European Organisation for Research and Treatment of Care (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the EuroQoL Five Dimensions Questionnaire (EQ-5D). Via a multi-step statistical plan, data were analyzed descriptively, cross-sectionally, and longitudinally, adjusting for baseline covariates, in patients having baseline plus =1 post-baseline assessment. Results: Baseline-adjusted completion rates for all HRQoL questionnaires across treatment arms were 65% and 70% for dacarbazine and nivolumab, respectively, and remained similar throughout treatment. The mean baseline HRQoL scores were similar for patients treated with nivolumab and dacarbazine. Baseline HRQoL levels with nivolumab were maintained over time. This exploratory analysis showed a between-arm difference in favor of nivolumab on the EQ-5D utility index and clinically meaningful EQ-5D improvements from baseline at several time points for patients receiving nivolumab. Patients treated with nivolumab did not show increased symptom burden as assessed by the EORTC QLQ-C30. No HRQoL change was noted with dacarbazine patients up to week 43, although the high attrition rate after week 13 did not allow any meaningful analyses. Patients receiving nivolumab deteriorated significantly later than those receiving dacarbazine on several EORTC QLQ-C30 scales and the EQ-5D utility index. Conclusions: In addition to prolonged survival, these exploratory HRQoL results show that nivolumab maintains baseline HRQoL levels to provide long-term quality of survival benefit, compared with dacarbazine in patients with advanced melanoma. [ABSTRACT FROM AUTHOR]

Competing Interests: A. Singh is a consultant for Boston Scientific. I. Waxman is a consultant for Boston Scientific, Cook Medical, and Medtronic. C. G. Chapman is a consultant for Boston Scientific, Olympus, Medtronic, Steris Endoscopy, Abbvie, and Phathom Pharmaceuticals. N. A. Mehta is a consultant for Boston Scientific and Castle Biosciences. A. Maniak, K. Garg, and G. Kakked declare that they have no conflict of interest.

Background:  Piecemeal endoscopic mucosal resection (EMR) is an acceptable technique for T1a esophageal adenocarcinoma, but en bloc R0 excision is advocated for T1b disease as it may offer a potential cure and mitigate recurrence. Thus, distinguishing between T1a and T1b disease is imperative under current treatment paradigms. We investigated whether expert Barrett's endoscopists could make this distinction based on optical evaluation., Methods:  Endoscopic images of histologically confirmed high grade dysplasia (HGD), T1a, and T1b disease (20 sets for each) were compiled from consecutive patients at a single institution. Each set contained four images including an overview, a close-up in high definition white light, a near-focus magnification image, and a narrow-band image. Experts predicted the histology for each set., Results:  19 experts from 8 countries (Australia, USA, Italy, Netherlands, Germany, Canada, Belgium, and Portugal) participated. The majority had been practicing for > 20 years, with a median (interquartile range) annual case volume of 50 (18-75) for Barrett's EMR and 25 (10-45) for Barrett's endoscopic submucosal dissection. Esophageal adenocarcinoma (T1a/b) could be distinguished from HGD with a pooled sensitivity of 89.1 % (95 %CI 84.7-93.4). T1b adenocarcinoma could be predicted with a pooled sensitivity of 43.8 % (95 %CI 29.9-57.7). Fleiss' kappa was 0.421 (95 %CI 0.399-0.442; P  < 0.001), indicating fair-to-moderate agreement., Conclusions:  Expert Barrett's endoscopists could reliably differentiate T1a/T1b esophageal adenocarcinoma from HGD. Despite fair-to-moderate agreement for T staging, T1b disease could not be reliably distinguished from T1a disease. This may impact clinical decision making and selection of endoscopic techniques., Competing Interests: N. Shahidi has received speaker honoraria from Boston Scientific and Pharmascience. M.B. Wallace is a consultant for Fujifilm, Boston Scientific, Endiatix, Verily, Medtronic, and InterVenn Biosciences. A. Repici has received research support from Fujifilm, Boston Scientific Corporation, and Norgine. M. Dinis-Ribeiro is a consultant for Medtronic and Roche. G.B. Haber is a consultant for Olympus and Ovesco. I. Waxman is a consultant for Medtronic, BSCI, and Cook Medical. P.D. Siersema has received research grants from MOTUS GI, Norgine, and Pentax. R. Pouw is a consultant for Medtronic BV and MicroTech Europe. A. Lemmers is a consultant for Cook, and has received research support from Boston Scientific. J.D. Mosko has received speaker/consulting fees from Boston Scientific, Pendopharm, Medtronic, and Fuji. C. Teshima has received speaker/consulting fees from Boston Scientific, consultant fees from Olympus, and speaker fees from Medtronic. K. Ragunath has received research support and grants from Olympus. T. Rösch has received advisory fees for Olympus, lecture honoraria from Falk and AbbVie, and research support from Olympus, Erbe, Fujifilm, and Microtech. O. Pech has received honoraria from Medtronic, Boston Scientific, Fujifilm, and Olympus. T. Beyna is a consultant for Olympus, Boston Scientific, MicroTech Endoscopy, and Fractyl. P. Sharma is a consultant for Boston Scientific and Olympus, and has received grant support from US Endoscopy, Medtronic, Fujifilm, Ironwood, Cosmo Pharmaceuticals, and Erbe. M.J. Bourke has received research support from Olympus, Cook Medical, and Boston Scientific. S. Gupta, F. Vito Mandarino, L. Hourigan, H. Messmann, A. Taylor, R. Bisschops, E.Y.T. Lee, and N.G. Burgess declare that they have no conflict of interest., (Thieme. All rights reserved.)

Background: Celiac plexus block has been commonly utilized for the treatment of chronic pancreatitis-associated abdominal pain. Prospective studies suggest efficacy in 30 to 50% of patients, although no randomized sham-controlled trials have been performed. The objective of this study is to assess the effect of endoscopic ultrasound (EUS)-guided celiac plexus block on abdominal pain in patients with documented chronic pancreatitis., Methods: This is a two-arm randomized sham-controlled trial with blinded evaluators. The study will be conducted at multiple academic sites in the United States who are members of the United States Pancreatic Disease Study Group (USPG). Patients referred for EUS to exclude chronic pancreatitis as a cause of abdominal pain as well as those with established painful chronic pancreatitis undergoing EUS for another indication will be eligible. At the time of EUS with confirmation of chronic pancreatitis by standard EUS diagnostic criteria, patients will be randomized to either celiac plexus block or sham whereby an anesthetic and steroid combination will be injected into the celiac plexus or saline will be injected into the gastric lumen with the same type of needle as used for celiac plexus block, respectively. The main outcome measure will be a 50% reduction in abdominal pain using the Brief Pain Inventory Short Form (BPI-SF) at 1 month post-intervention. A number of secondary outcomes will be measured including visual analog scale (VAS), Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) pain scores, and quality of life using a pancreas-specific validated measure (PANQOLI)., Discussion: In this study, the effect of celiac plexus block on abdominal pain in patients with chronic pancreatitis will be compared to a sham intervention. This randomized trial will offer a definitive assessment of the role of celiac plexus block for the treatment of abdominal pain in this setting. TRIAL REGISTRATION {2}: ClinicalTrials.gov NCT06178315. Registered on December 21, 2023., (© 2024. The Author(s).)

Background and Aims: Inefficiencies in the endoscopy suite cause frustration for physicians, hospital administrators, staff, and patients. Turnover time (TOT), the time between one case ending and another beginning, is subjectively disproportionate between various team members. We aimed to define perceptions of TOT and target steps within the process to improve efficiency., Methods: This was a prospective cohort study at a tertiary center outpatient endoscopy unit. Phase I aimed to identify the TOT process components based on time stamps in the electronic medical record (N = 686). We defined gastroenterologist perceived TOT (pTOT), anesthesia pTOT, and standard TOT (sTOT). TOT length was calculated for each subgroup. Patient transport was identified as an intervenable target. In Phase II, the task of patient transport moved from the anesthesiology team to endoscopy nurses. Mean TOT and proportion of cases with sTOT <15 minutes' preintervention (n = 2192) and postintervention (n = 292) were compared., Results: Seven key TOT components were identified that explain variations in pTOT. Average anesthesia pTOT was 15 minutes, whereas average gastroenterologist pTOT was 34 minutes (25.9% vs 57.2% of case length; P = .0007). In Phase II, mean sTOT improved from 18.51 to 14.25 minutes (P < .0001), and proportion of sTOT within 15 minutes improved from 41.79% to 58.90% (P < .0001). This intervention saved 45 minutes per room per day, allowing for a revenue potential of more than $300,000 per year per procedure room., Conclusions: This study defines variations in TOT and shows that finding imbalances and sharing the workload significantly cuts costs and improves the overall efficiency of the different subgroups in the turnover process., Competing Interests: Disclosure The following authors disclosed financial relationships: I. Waxman: consultant for Medtronic, Wilson Cook, and BSCI; and advisory board member for Magentiq Eye Ltd. N.A. Mehta: consultant for Boston Scientific, ConMed, and Castle Biosciences. All other authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The American Society for Gastrointestinal Endoscopy (ASGE) AI Task Force along with experts in endoscopy, technology space, regulatory authorities, and other medical subspecialties initiated a consensus process that analyzed the current literature, highlighted potential areas, and outlined the necessary research in artificial intelligence (AI) to allow a clearer understanding of AI as it pertains to endoscopy currently., Methods: A modified Delphi process was used to develop these consensus statements., Results: Statement 1: Current advances in AI allow for the development of AI-based algorithms that can be applied to endoscopy to augment endoscopist performance in detection and characterization of endoscopic lesions. Statement 2: Computer vision-based algorithms provide opportunities to redefine quality metrics in endoscopy using AI, which can be standardized and can reduce subjectivity in reporting quality metrics. Natural language processing-based algorithms can help with the data abstraction needed for reporting current quality metrics in GI endoscopy effortlessly. Statement 3: AI technologies can support smart endoscopy suites, which may help optimize workflows in the endoscopy suite, including automated documentation. Statement 4: Using AI and machine learning helps in predictive modeling, diagnosis, and prognostication. High-quality data with multidimensionality are needed for risk prediction, prognostication of specific clinical conditions, and their outcomes when using machine learning methods. Statement 5: Big data and cloud-based tools can help advance clinical research in gastroenterology. Multimodal data are key to understanding the maximal extent of the disease state and unlocking treatment options. Statement 6: Understanding how to evaluate AI algorithms in the gastroenterology literature and clinical trials is important for gastroenterologists, trainees, and researchers, and hence education efforts by GI societies are needed. Statement 7: Several challenges regarding integrating AI solutions into the clinical practice of endoscopy exist, including understanding the role of human-AI interaction. Transparency, interpretability, and explainability of AI algorithms play a key role in their clinical adoption in GI endoscopy. Developing appropriate AI governance, data procurement, and tools needed for the AI lifecycle are critical for the successful implementation of AI into clinical practice. Statement 8: For payment of AI in endoscopy, a thorough evaluation of the potential value proposition for AI systems may help guide purchasing decisions in endoscopy. Reliable cost-effectiveness studies to guide reimbursement are needed. Statement 9: Relevant clinical outcomes and performance metrics for AI in gastroenterology are currently not well defined. To improve the quality and interpretability of research in the field, steps need to be taken to define these evidence standards. Statement 10: A balanced view of AI technologies and active collaboration between the medical technology industry, computer scientists, gastroenterologists, and researchers are critical for the meaningful advancement of AI in gastroenterology., Conclusions: The consensus process led by the ASGE AI Task Force and experts from various disciplines has shed light on the potential of AI in endoscopy and gastroenterology. AI-based algorithms have shown promise in augmenting endoscopist performance, redefining quality metrics, optimizing workflows, and aiding in predictive modeling and diagnosis. However, challenges remain in evaluating AI algorithms, ensuring transparency and interpretability, addressing governance and data procurement, determining payment models, defining relevant clinical outcomes, and fostering collaboration between stakeholders. Addressing these challenges while maintaining a balanced perspective is crucial for the meaningful advancement of AI in gastroenterology., Competing Interests: Disclosure The following authors disclosed financial relationships: S. Parasa: Consultant for Medtronic and Microsoft Research; advisory board for the Allen Institute for Artificial Intelligence and Fujifilm; research support from Fujifilm. T. Berzin: Consultant for Medtronic, Wision AI, Magentiq Eye, RSIP Vision, and Docbot AI. C. Leggett: Consultant for Verily Life Sciences. S. Gross: Consultant for Medtronic and Iterative Scopes. A. Repici: Research support from Fujifilm, Boston Scientific Corporation, and Norgine; speaker for Boston Scientific Corporation and Norgine. O. F. Ahmad: Speaker for Olympus Corporation and Medtronic. A. Chiang: Employee at Medtronic. N. Coelho-Prabhu: Scientific advisory board for Iterative Health. J. Cohen: Consultant for Olympus and Micro-Tech; stock in GI Windows, Virtual Health Partners, and Rom-Tech; owner of MD Medical Navigators. E. Dekker: Research support from Fujifilm; consultant for Fujifilm, Olympus, Ambu, and InterVenn; speaker for Olympus, Fujifilm, GI Supply, IPSEN, PAION, and Norgine. R. N. Keswani: Consultant for Boston Scientific Corporation and Medtronic. C. E. Kahn: Travel compensation from Sectra USA; advisory council for Epic Corporation. C. Hassan: Consultant for Odin, Fujifilm, Olympus, and NEC. P. Mountney: Employment relationship with Odin Medical Limited and Olympus Medical. J. Ng: Chief executive officer and founder of Iterative Health. Y. Mori: Consultant for Olympus; speaker for Olympus; device loan from Olympus; royalties from Cybernet System. S. Thakkar: Consultant for Boston Scientific Corporation and Medtronic; advisor for Iterative Scopes. I. Waxman: Consultant for Medtronic, BSCI, and Cook Medical; advisory board for Magentiq Eye. M. B. Wallace: Consultant for Boston Scientific Corporation, Cosmo/Aries Pharmaceuticals, Verily, Endiatix, Intervenn, AlphaMed UAE, Fujifilm, and ClearNote; research support from Cosmo/Aries Pharmaceuticals and Boston Scientific Corporation; independent contractor for Olympus, Medtronic, and Ninepoint Medical; stock in Virgo Inc. P. Sharma: Consultant for Bausch, Boston Scientific Corporation, CDx Labs, Covidien LP, Exact Sciences, Fujifilm Medical Systems USA, Inc, Lucid, Lumendi, Medtronic, Olympus America, Inc, and Salix; research support from Cosmo Pharmaceuticals, Covidien, Docbot, Erbe USA Inc, Fujifilm Holdings America Corporation, Ironwood Pharmaceuticals, Inc, Medtronic USA, Inc, Olympus, Salix, and US Endoscopy. All other authors disclosed no financial relationships., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Video 1A case characterizing the extent and morphology of an intraductal mucinous biliary neoplasm using a novel cholangioscope and treatment with ampullectomy., Competing Interests: Dr Mehta is a consultant for Boston Scientific, Conmed, and Medtronic. Dr Waxman is a consultant for Boston Scientific, Medtronic, and Cook Medical. All other authors disclosed no financial relationships relevant to this publication., (© 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)

Barrett's esophagus (BE) is the precursor to esophageal adenocarcinoma (EAC), and is caused by chronic gastroesophageal reflux. BE can progress over time from metaplasia to dysplasia, and eventually to EAC. EAC is associated with a poor prognosis, often due to advanced disease at the time of diagnosis. However, if BE is diagnosed early, pharmacologic and endoscopic treatments can prevent progression to EAC. The current standard of care for BE surveillance utilizes the Seattle protocol. Unfortunately, a sizable proportion of early EAC and BE-related high-grade dysplasia (HGD) are missed due to poor adherence to the Seattle protocol and sampling errors. New modalities using artificial intelligence (AI) have been proposed to improve the detection of early EAC and BE-related HGD. This review will focus on AI technology and its application to various endoscopic modalities such as high-definition white light endoscopy, narrow-band imaging, and volumetric laser endomicroscopy.

Background: Although the preferred management approach for patients with infected necrotising pancreatitis is endoscopic transluminal stenting followed by endoscopic necrosectomy as step-up treatment if there is no clinical improvement, the optimal timing of necrosectomy is unclear. Therefore, we aimed to compare outcomes between performing upfront necrosectomy at the index intervention versus as a step-up measure in patients with infected necrotising pancreatitis., Methods: This single-blinded, multicentre, randomised trial (DESTIN) was done at six tertiary care hospitals (five hospitals in the USA and one hospital in India). We enrolled patients (aged ≥18 years) with confirmed or suspected infected necrotising pancreatitis with a necrosis extent of at least 33% who were amenable to endoscopic ultrasound-guided drainage. By use of computer-generated permuted block randomisation (block size four), eligible patients were randomly assigned (1:1) to receive either upfront endoscopic necrosectomy or endoscopic step-up treatment. Endoscopists were not masked to treatment allocation, but participants, research coordinators, and the statistician were. Lumen-apposing metal stents (20 mm diameter; 10 mm saddle length) were used for drainage in both groups. In the upfront group, direct necrosectomy was performed immediately after stenting in the same treatment session. In the step-up group, direct necrosectomy or additional drainage was done at a subsequent treatment session if there was no clinical improvement (resolution of any criteria of systemic inflammatory response syndrome or sepsis or one or more organ failure and at least a 25% percentage decrease in necrotic collection size) 72 h after stenting. The primary outcome was the number of reinterventions per patient to achieve treatment success from index intervention to 6 months' follow-up, which was defined as symptom relief in conjunction with disease resolution on CT. Reinterventions included any endoscopic or radiological procedures performed for necrosectomy or additional drainage after the index intervention, excluding the follow-up procedure at 4 weeks for stent removal. All endpoints and safety were analysed by intention-to-treat. This study is registered with ClinicalTrials.gov, NCT05043415 and NCT04113499, and recruitment and follow-up have been completed., Findings: Between Nov 27, 2019, and Oct 26, 2022, 183 patients were assessed for eligibility and 70 patients (24 [34%] women and 46 [66%] men) were randomly assigned to receive upfront necrosectomy (n=37) or step-up treatment (n=33) and included in the intention-to-treat population. At the time of index intervention, seven (10%) of 70 patients had organ failure and 64 (91%) patients had walled-off necrosis. The median number of reinterventions was significantly lower for upfront necrosectomy (1 [IQR 0 to 1] than for the step-up approach (2 [1 to 4], difference -1 [95% CI -2 to 0]; p=0·0027). Mortality did not differ between groups (zero patients in the upfront necrosectomy group vs two [6%] in the step-up group, difference -6·1 percentage points [95% CI -16·5 to 4·5]; p=0·22), nor did overall disease-related adverse events (12 [32%] patients in the upfront necrosectomy group vs 16 [48%] patients in the step-up group, difference -16·1 percentage points [-37·4 to 7·0]; p=0·17), nor procedure-related adverse events (four [11%] patients in the upfront necrosectomy group vs eight [24%] patients in the step-up group, difference -13·4 percentage points [-30·8 to 5·0]; p=0·14)., Interpretation: In stabilised patients with infected necrotising pancreatitis and fully encapsulated collections, an approach incorporating upfront necrosectomy at the index intervention rather than as a step-up measure could safely reduce the number of reinterventions required to achieve treatment success., Funding: None., Competing Interests: Declaration of interests JYB is a consultant for Olympus America and Boston Scientific. SV is a consultant for Boston Scientific, Olympus America, and Medtronic. RHH is a consultant for Olympus America, Fujifilm, and GIE Medical. UN is a consultant for Janssen, Takeda, AbbVie, Bristol Myers Squibb, and GIE Medical, and is a member of the Crohn's and Colitis Foundation. ST is a consultant for Boston Scientific, Guidepoint, and Medtronic. IW is a consultant for Boston Scientific, Cook Medical, and Medtronic. SS is a consultant for Boston Scientific, Apollo Endosurgery, and Fujifilm. JLB is a consultant for Boston Scientific and Olympus America. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background and Aims: Endoscopic decompression is considered a first-line treatment for symptomatic pancreatic fluid collections (PFCs). A lumen-apposing metal stent (LAMS) with an electrocautery-enhanced delivery system [electrocautery-enhanced lumen-apposing metal stent (ELAMS)] may facilitate this procedure. This study evaluated the safety and efficacy of ELAMS in the management of symptomatic PFCs., Patients and Methods: A multicenter, nonblinded, prospective, Food and Drug Administration (FDA)-approved, investigational device exemption clinical trial was conducted. Enrollment criteria included symptomatic PFCs ≥6 cm with ≥70% fluid fraction. Subjects were followed prospectively for safety, efficacy, and resolution of the collections. Primary endpoint success was defined as ≥50% reduction in PFC size. Clinical outcomes were compared with our previously published series of LAMS without the cautery-enhanced delivery system., Results: The target enrollment of 30 patients was achieved in 7 US tertiary care centers. All patients underwent successful placement of the ELAMS. The mean procedure duration, stent placement time, and fluoroscopy exposures were 28.1±12.5, 5.8±2.6, and 1.8±1.6 minutes, respectively. Eight patients had no fluoroscopy. The primary endpoint was achieved in 83.3% of patients. Two adverse events were attributed to the ELAMS: 1 bleeding upon stent removal and 1 stent migration. Relative to the comparator noncautery LAMS multicenter trial (N=33, 8 tertiary centers), there was a significantly shorter procedure duration [36 min ( P <0.001)] with similar technical and clinical outcomes in the ELAMS cohort., Conclusion: LAMS placed using an electrocautery delivery system significantly reduce procedure duration and were safe and effective in the management of symptomatic PFCs., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Context.—: Endoscopic mucosal resection (EMR) has made it possible for Barrett esophagus patients with superficial cancers to be treated without esophagectomy. Recent guidelines recommend measuring depth of invasion (DOI) in submucosal cancers based on reports that in low-risk cancers, submucosal invasion 500 μm or less is associated with low nodal metastasis rates. However, pathologists face challenges in reproducibly measuring DOI., Objective.—: To determine how often DOI measurements could impact treatment and to evaluate reproducibility in measuring submucosal DOI in EMR specimens., Design.—: Consecutive adenocarcinoma EMR cases were identified, including cases of "low histologic risk" submucosal cancer, as follows: those with negative deep margins, no high-grade histology (G3), and no lymphovascular invasion. Submucosal DOI was measured by 7 pathologists according to guidelines., Results.—: Of 213 cancer EMR cases, 46 were submucosa invasive and 6 cases were low histologic risk submucosal cancers for which measurement could impact decision-making. Of these low histologic risk cases, 3 were categorized as superficial, indicating that measurement would be a clinically actionable decision point in only 1.4% of adenocarcinoma EMRs. Interobserver agreement for in-depth categorization between 7 pathologists was moderate (κ = 0.42), and the range of measurements spanned the 500-μm relevant threshold in 40 of 55 measured samples (72.7%)., Conclusions.—: While therapeutic decisions would rarely have depended on DOI measurements alone in our cohort, interobserver variability raises concerns about their use as a sole factor on which to offer patients conservative therapy. Responsibly reporting and clinically using submucosal DOI measurements will require practical experience troubleshooting common histologic artifacts, as well as multidisciplinary awareness of the impact of variable specimen-handling practices., (© 2022 College of American Pathologists.)

Background & Aims: Despite the significant advances made in the diagnosis and treatment of Barrett's esophagus (BE), there is still a need for standardized definitions, appropriate recognition of endoscopic landmarks, and consistent use of classification systems. Current controversies in basic definitions of BE and the relative lack of anatomic knowledge are significant barriers to uniform documentation. We aimed to provide consensus-driven recommendations for uniform reporting and global application., Methods: The World Endoscopy Organization Barrett's Esophagus Committee appointed leaders to develop an evidence-based Delphi study. A working group of 6 members identified and formulated 23 statements, and 30 internationally recognized experts from 18 countries participated in 3 rounds of voting. We defined consensus as agreement by ≥80% of experts for each statement and used the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tool to assess the quality of evidence and the strength of recommendations., Results: After 3 rounds of voting, experts achieved consensus on 6 endoscopic landmarks (palisade vessels, gastroesophageal junction, squamocolumnar junction, lesion location, extraluminal compressions, and quadrant orientation), 13 definitions (BE, hiatus hernia, squamous islands, columnar islands, Barrett's endoscopic therapy, endoscopic resection, endoscopic ablation, systematic inspection, complete eradication of intestinal metaplasia, complete eradication of dysplasia, residual disease, recurrent disease, and failure of endoscopic therapy), and 4 classification systems (Prague, Los Angeles, Paris, and Barrett's International NBI Group). In round 1, 18 statements (78%) reached consensus, with 12 (67%) receiving strong agreement from more than half of the experts. In round 2, 4 of the remaining statements (80%) reached consensus, with 1 statement receiving strong agreement from 50% of the experts. In the third round, a consensus was reached on the remaining statement., Conclusions: We developed evidence-based, consensus-driven statements on endoscopic landmarks, definitions, and classifications of BE. These recommendations may facilitate global uniform reporting in BE., (Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.)