Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial.

BACKGROUND: The combination of rectally administered indomethacin and placement of a prophylactic pancreatic stent is recommended to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients. Preliminary evidence suggests that the use of indomethacin might eliminate or substantially reduce the need for stent placement, a technically complex, costly, and potentially harmful intervention. METHODS: In this randomised, non-inferiority trial conducted at 20 referral centres in the USA and Canada, patients (aged ≥18 years) at high risk for post-ERCP pancreatitis were randomly assigned (1:1) to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent. Patients, treating clinicians, and outcomes assessors were masked to study group assignment. The primary outcome was post-ERCP pancreatitis. To declare non-inferiority, the upper bound of the two-sided 95% CI for the difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) would have to be less than 5% (non-inferiority margin) in both the intention-to-treat and per-protocol populations. This trial is registered with ClinicalTrials.gov (NCT02476279), and is complete. FINDINGS: Between Sept 17, 2015, and Jan 25, 2023, a total of 1950 patients were randomly assigned. Post-ERCP pancreatitis occurred in 145 (14·9%) of 975 patients in the indomethacin alone group and in 110 (11·3%) of 975 in the indomethacin plus stent group (risk difference 3·6%; 95% CI 0·6-6·6; p=0·18 for non-inferiority). A post-hoc intention-to-treat analysis of the risk difference between groups showed that indomethacin alone was inferior to the combination of indomethacin plus prophylactic stent (p=0·011). The relative benefit of stent placement was generally consistent across study subgroups but appeared more prominent among patients at highest risk for pancreatitis. Safety outcomes (serious adverse events, intensive care unit admission, and hospital length of stay) did not differ between groups. INTERPRETATION: For preventing post-ERCP pancreatitis in high-risk patients, a strategy of indomethacin alone was not as effective as a strategy of indomethacin plus prophylactic pancreatic stent placement. These results support prophylactic pancreatic stent placement in addition to rectal indomethacin administration in high-risk patients, in accordance with clinical practice guidelines. FUNDING: US National Institutes of Health.

Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial).

BACKGROUND & AIMS: Endoscopic ultrasound-guided choledochoduodenostomy with a lumen-apposing metal stent (EUS-CDS) is a promising modality for management of malignant distal biliary obstruction (MDBO) with potential for better stent patency. We compared its outcomes with endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M). METHODS: In this multicenter randomized controlled trial, we recruited patients with MDBO secondary to borderline resectable, locally advanced, or unresectable peri-ampullary cancers across 10 Canadian institutions and 1 French institution. This was a superiority trial with a noninferiority assessment of technical success. Patients were randomized to EUS-CDS or ERCP-M. The primary end point was the rate of stent dysfunction at 1 year, considering competing risks of death, clinical failure, and surgical resection. Analyses were performed according to intention-to-treat principles. RESULTS: From February 2019 to February 2022, 144 patients were recruited; 73 were randomized to EUS-CDS and 71 were randomized to ERCP-M. The mean (SD) procedure time was 14.0 (11.4) minutes for EUS-CDS and 23.1 (15.6) minutes for ERCP-M (P < .01); 40% of the former was performed without fluoroscopy. Technical success was achieved in 90.4% (95% CI, 81.5% to 95.3%) of EUS-CDS and 83.1% (95% CI, 72.7% to 90.1%) of ERCP-M with a risk difference of 7.3% (95% CI, -4.0% to 18.8%) indicating noninferiority. Stent dysfunction occurred in 9.6% vs 9.9% of EUS-CDS and ERCP-M cases, respectively (P = .96). No differences in adverse events, pancreaticoduodenectomy and oncologic outcomes, or quality of life were noted. CONCLUSIONS: Although not superior in stent function, EUS-CDS is an efficient and safe alternative to ERCP-M in patients with MDBO. These findings provide evidence for greater adoption of EUS-CDS in clinical practice as a complementary and exchangeable first-line modality to ERCP in patients with MDBO. CLINICALTRIALS: gov, Number: NCT03870386.

Incidence, Predictors, and Outcomes of Clinically Significant Post-ERCP Bleeding: a Contemporary Multi-center Study.

BACKGROUND AIMS: Clinically significant post-endoscopic retrograde cholangiopancreatography (ERCP) bleeding (CSPEB) is common. Contemporary estimates of risk are lacking. We aimed to identify risk factors for and outcomes following CSPEB. METHODS: We analyzed multi-center prospective ERCP data between 2018-2023 with 30-day follow-up. The primary outcome was CSPEB, defined as hematemesis, melena, or hematochezia resulting in: hemoglobin drop ≥20 g/L or transfusion and/or endoscopy to evaluate suspected bleeding, and/or unplanned healthcare visitation and/or prolongation of existing admission. Firth logistic regression was employed. P-values <0.05 were significant, with odds ratios (ORs) and 95% confidence intervals reported. RESULTS: CSPEB occurred following 129 (1.5%) of 8,517 ERCPs (mean onset 3.2 days), with 110 of 4,849 events (2.3%) occurring following higher-risk interventions (sphincterotomy, sphincteroplasty, pre-cut sphincterotomy, and/or needle-knife access). CSPEB patients required endoscopy and transfusion in 86.0% and 53.5% of cases, respectively, with three cases (2.3%) being fatal. P2Y12 inhibitors were held for a median of 4 days (IQR 4) prior to higher-risk ERCP. Following higher-risk interventions, P2Y12 inhibitors (OR 3.33, 1.26-7.74), warfarin (OR 8.54, 3.32-19.81), dabigatran (OR 13.40, 2.06-59.96), rivaroxaban (OR 7.42, 3.43-15.24) and apixaban (OR 4.16, 1.99-8.20) were associated with CSPEB. Significant intraprocedural bleeding post sphincterotomy (OR 2.32, 1.06-4.60), but not post sphincteroplasty, was also associated. Concomitant cardiorespiratory events occurred more frequently within 30 days following CSPEB (OR 12.71, 4.75-32.54). CONCLUSIONS: Risks of antiplatelet-related CSPEB may be underestimated by endoscopists based on observations of suboptimal holding before higher-risk ERCP. Appropriate periprocedural antithrombotic management is essential and could represent novel quality initiative targets.

Post-ERCP cholecystitis: Incidence, characteristics, and outcomes from a prospective multicenter biliary endoscopy registry.

BACKGROUND AND AIMS: The incidence, risk factors, and outcomes of post-ERCP cholecystitis are poorly described. We aimed to describe cases of post-ERCP cholecystitis from a prospective multicenter registry with protocolized 30-day follow-up. METHODS: Patient- and procedure-related data from 7 centers were obtained. The primary outcome was post-ERCP cholecystitis, defined according to a Delphi-based criteria and causal attribution system. Risk factors and outcomes were described for all cases. RESULTS: Seventeen cases of post-ERCP cholecystitis were identified among 4428 patients with gallbladders undergoing ERCP between 2018 and 2023 (incidence, 0.38%; 95% confidence interval, 0.20-0.57). In ERCPs with covered metal stenting, 7 of 467 resulted in cholecystitis (incidence, 1.50%; 95% confidence interval, 0.40-2.60). Patients had symptoms at a median of 5 days (interquartile range, 5) after ERCP. Management strategies included cholecystectomy, percutaneous cholecystostomy, and endoscopic stent removal/exchange. CONCLUSIONS: Estimates of post-ERCP cholecystitis incidence can inform discussions around procedural risk.

Aspirin exposure and its association with metal stent patency in malignant distal biliary obstruction: a large international multicenter propensity score-matched study.

BACKGROUND AND AIMS: Stent dysfunction is common after ERCP with self-expandable metal stent (SEMS) insertion for malignant distal biliary obstruction (MDBO). Chronic aspirin (acetylsalicylic acid; ASA) exposure has been previously shown to potentially decrease this risk. We aim to further ascertain the protective effect of ASA and to identify other predictors of stent dysfunction. METHODS: This multicenter retrospective cohort study was conducted at 9 sites in Canada and 1 in the United States. Patients with MDBO who underwent ERCP with SEMS placement between January 2014 and December 2019 were included and divided into 2 cohorts: ASA exposed (ASA-E) and ASA unexposed (ASA-U). Propensity-score matching (PSM) was performed to limit selection bias. Matched variables were age, sex, tumor stage, and type of metal stent. The primary outcome was the hazard rate of stent dysfunction. A multivariable Cox proportional hazards model was used to identify independent predictors of stent dysfunction. RESULTS: Of 1396 patients assessed, after PSM 496 patients were analyzed (248 ASA-E and 248 ASA-U). ERCP with SEMS placement was associated with a high clinical success of 82.2% in ASA-E and 81.2% in ASA-U cohorts (P = .80). One hundred eighty-four patients had stent dysfunction with a mean stent patency time of 229.9 ± 306.2 days and 245.4 ± 241.4 days in ASA-E and ASA-U groups, respectively (P = .52). On multivariable analysis, ASA exposure did not protect against stent dysfunction (hazard ratio [HR], 1.25; 95% confidence interval [CI], .96-1.63). An etiology of pancreatic cancer (HR, 1.36; 95% CI, 1.15-1.61) predicted stent dysfunction, whereas cancer therapy was protective (HR, .73; 95% CI, .55-.96). Chronic ASA use was not associated with an increased risk for adverse events including bleeding, post-ERCP pancreatitis, and perforation. CONCLUSIONS: In this large, multicenter study using PSM, chronic exposure to ASA did not protect against stent dysfunction in MDBO. Instead, the analysis revealed that the etiology of pancreatic cancer was an independent predictor of stent dysfunction and cancer therapy was protective.

Modified endoscopic ultrasound-guided double-balloon-occluded gastroenterostomy bypass (M-EPASS): a pilot study.

INTRODUCTION: We recently developed a double-balloon device, using widely available existing technology, to facilitate endoscopic ultrasound-guided gastroenterostomy (EUS-GE). Our aim is to assess the feasibility of this modified approach to EUS-guided double-balloon-occluded gastroenterostomy bypass (M-EPASS). METHODS: This was a single-center retrospective study of consecutive patients undergoing M-EPASS from January 2019 to August 2020. The double-balloon device consists of two vascular balloons that optimize the distension of a targeted small-bowel segment for EUS-guided stent insertion. The primary end point was the rate of technical success. RESULTS: 11 patients (45 % women; mean [standard deviation (SD)] age 64.9 [8.6]) with malignant gastric outlet obstruction were included. Technical and clinical success (ability to tolerate an oral diet) were achieved in 91 % (10/11) and 80 % (8/10) of patients, respectively. There was one adverse event (9 %) due to stent migration. Two patients (18 %) required re-intervention for stent obstruction secondary to food impaction. The mean (SD) time to a low residue diet was 3.5 (2.4) days. CONCLUSION: M-EPASS appears to facilitate the technique of EUS-GE, potentially enhancing its safety and clinical adoption. Larger studies are needed to validate this innovative approach to gastric outlet obstruction.

Endoscopic ultrasound (EUS)-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration with rapid onsite evaluation in pancreatic lesions: a multicenter randomized trial.

BACKGROUND: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the standard in the diagnosis of solid pancreatic lesions, in particular when combined with rapid onsite evaluation of cytopathology (ROSE). More recently, a fork-tip needle for core biopsy (FNB) has been shown to be associated with excellent diagnostic yield. EUS-FNB alone has however not been compared with EUS-FNA + ROSE in a large clinical trial. Our aim was to compare EUS-FNB alone to EUS-FNA + ROSE in solid pancreatic lesions. METHODS: A multicenter, non-inferiority, randomized controlled trial involving seven centers was performed. Solid pancreatic lesions referred for EUS were considered for inclusion. The primary end point was diagnostic accuracy. Secondary end points included sensitivity/specificity, mean number of needle passes, and cost. RESULTS: 235 patients were randomized: 115 EUS-FNB alone and 120 EUS-FNA + ROSE. Overall, 217 patients had malignant histology. The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA + ROSE at 92.2 % (95 %CI 86.6 %-96.9 %) and 93.3 % (95 %CI 88.8 %-97.9 %), respectively (P = 0.72). Diagnostic sensitivity for malignancy was 92.5 % (95 %CI 85.7 %-96.7 %) for EUS-FNB alone vs. 96.5 % (93.0 %-98.6 %) for EUS-FNA + ROSE (P = 0.46), while specificity was 100 % in both. Adequate histological yield was obtained in 87.5 % of the EUS-FNB samples. The mean (SD) number of needle passes and procedure time favored EUS-FNB alone (2.3 [0.6] passes vs. 3.0 [1.1] passes [P < 0.001]; and 19.3 [8.0] vs. 22.7 [10.8] minutes [P = 0.008]). EUS-FNB alone cost on average 45 US dollars more than EUS-FNA + ROSE. CONCLUSION: EUS-FNB alone is non-inferior to EUS-FNA + ROSE and is associated with fewer needle passes, shorter procedure time, and excellent histological yield at comparable cost.

Is Biannual Surveillance for Pancreatic Cancer Sufficient in Individuals With Genetic Syndromes or Familial Pancreatic Cancer?

BACKGROUND: Individuals with a family history of pancreatic adenocarcinoma (PC) or with a germline mutation in a PC susceptibility gene are at increased risk of developing PC. These high-risk individuals (HRIs) may benefit from PC surveillance. METHODS: A PC surveillance program was developed to evaluate the detection of premalignant lesions and early-stage PCs using biannual imaging and to determine whether locally advanced or metastatic PCs develop despite biannual surveillance. From January 2013 to April 2020, asymptomatic HRIs were enrolled and followed with alternating MRI and endoscopic ultrasound every 6 months. RESULTS: Of 75 HRIs, 43 (57.3%) had a germline mutation in a PC susceptibility gene and 32 (42.7%) had a familial pancreatic cancer (FPC) pedigree. Branch-duct intraductal papillary mucinous neoplasms (BD-IPMNs) were identified in 26 individuals (34.7%), but only 2 developed progressive lesions. One patient with Peutz-Jeghers syndrome (PJS) developed locally advanced PC arising from a BD-IPMN. Whole-genome sequencing of this patient's PC and of a second patient with PJS-associated PC from the same kindred revealed biallelic inactivation of STK11 in a KRAS-independent manner. A review of 3,853 patients from 2 PC registries identified an additional patient with PJS-associated PC. All 3 patients with PJS developed advanced PC consistent with the malignant transformation of an underlying BD-IPMN in <6 months. The other surveillance patient with a progressive lesion had FPC and underwent resection of a mixed-type IPMN that harbored polyclonal KRAS mutations. CONCLUSIONS: PC surveillance identifies a high prevalence of BD-IPMNs in HRIs. Patients with PJS with BD-IPMNs may be at risk for accelerated malignant transformation.

Efficacy of Endoscopic Submucosal Dissection for Superficial Gastric Neoplasia in a Large Cohort in North America.

BACKGROUND & AIMS: Endoscopic submucosal dissection (ESD) is a widely accepted treatment option for superficial gastric neoplasia in Asia, but there are few data on outcomes of gastric ESD from North America. We aimed to evaluate the safety and efficacy of gastric ESD in North America. METHODS: We analyzed data from 347 patients who underwent gastric ESD at 25 centers, from 2010 through 2019. We collected data on patient demographics, lesion characteristics, procedure details and related adverse events, treatment outcomes, local recurrence, and vital status at the last follow up. For the 277 patients with available follow-up data, the median interval between initial ESD and last clinical or endoscopic evaluation was 364 days. The primary endpoint was the rate of en bloc and R0 resection. Secondary outcomes included curative resection, rates of adverse events and recurrence, and gastric cancer-related death. RESULTS: Ninety patients (26%) had low-grade adenomas or dysplasia, 82 patients (24%) had high-grade dysplasia, 139 patients (40%) had early gastric cancer, and 36 patients (10%) had neuroendocrine tumors. Proportions of en bloc and R0 resection for all lesions were 92%/82%, for early gastric cancers were 94%/75%, for adenomas and low-grade dysplasia were 93%/ 92%, for high-grade dysplasia were 89%/ 87%, and for neuroendocrine tumors were 92%/75%. Intraprocedural perforation occurred in 6.6% of patients; 82% of these were treated successfully with endoscopic therapy. Delayed bleeding occurred in 2.6% of patients. No delayed perforation or procedure-related deaths were observed. There were local recurrences in 3.9% of cases; all occurred after non-curative ESD resection. Metachronous lesions were identified in 14 patients (6.9%). One of 277 patients with clinical follow up died of metachronous gastric cancer that occurred 2.5 years after the initial ESD. CONCLUSIONS: ESD is a highly effective treatment for superficial gastric neoplasia and should be considered as a viable option for patients in North America. The risk of local recurrence is low and occurs exclusively after non-curative resection. Careful endoscopic surveillance is necessary to identify and treat metachronous lesions.

Novel Negative Pressure Protective Box in Upper Digestive Endoscopy: A Prospective Case Series.

In the context of the Severe Acute Respiratory Syndrome Coronavirus 2 pandemic, we have developed a novel negative pressure aerosol protector for upper endoscopy (TRACEY). TRACEY is the first endoscopic enclosure to have passed stringent testing for aerosol protection. The following describes its clinical use in a single-center prospective case series. Overall, 15 patients were included. All endoscopic procedures were successful without premature removal of TRACEY. In addition, its use did not lead to significant patient discomfort, technical hinderance, or adverse events. TRACEY seems to offer a safe and easy to use aerosol protection for upper endoscopy and a potential Severe Acute Respiratory Syndrome Coronavirus 2 mitigation strategy in endoscopy.

Endosonography-guided transmural drainage of pancreatic fluid collections: comparative outcomes by stent type.

BACKGROUND: Pancreatic fluid collections (PFCs), including walled-off necrosis (WON), are commonly described sequelae of pancreatitis. Endosonography-guided PFC drainage can be performed using plastic stents (PS), fully covered self-expanding metal stents (FCSEMS), or lumen-apposing metal stents (LAMS). We performed a retrospective study comparing clinical outcomes and adverse events by stent type. METHODS: In this historical cohort, patients undergoing endosonography-guided PFC drainage from 2010 to 2019 were divided into groups: those treated with (1) PS, (2) FCSEMS, and (3) LAMS. Clinical success, the primary outcome, was defined as complete resolution or size reduction of ≥ 50%, with resolution of symptoms and no reintervention required at 3 months following the index procedure. Adverse events (AEs) and procedure times were also evaluated. RESULTS: Fifty-eight patients were included. Procedure times were significantly shorter with LAMS (21.4 ± 10.8 min versus 53.0 ± 24.4 min for FCSEMS and 65.9 ± 23.4 min for PS, p < 0.001). Clinical success rates for WON were higher with LAMS compared with FCSEMS (95.7% vs 66.7%, respectively; p = 0.04). For all PFCs, treatment with LAMS trended towards higher clinical success rates compared with PS and FCSEMS (96.3% vs 81.8% vs 77.8%, respectively; p = 0.14). Early AEs (within 1 week) occurred at significantly lower rates in the LAMS group compared to PS and FCSEMS (0% vs 33.3% vs 10.6%, respectively; p = 0.006), as did late AEs (7.4% vs 44.5% vs 40%, respectively; p = 0.01). CONCLUSIONS: LAMS is superior in terms of WON clinical success, favorable in terms of lower adverse event profile, and shorter in terms of procedural time compared to FCSEMS and PS. LAMS can be considered as an initial approach for WON, given that clinical success in WON is lower when using PS or FCSEMS, though more high-quality data are needed.

EUS-guided gastroenterostomy versus duodenal stent placement and surgical gastrojejunostomy for the palliation of malignant gastric outlet obstruction: a systematic review and meta-analysis.

PURPOSE: Malignant gastric outlet obstruction (GOO) is associated with significant morbidity and decreased quality of life, thereby necessitating effective and safe palliative treatment. As such, we sought to compare endoscopic ultrasound-guided gastroenterostomy (EUS-GE) versus duodenal stent (DS) placement and surgical gastrojejunostomy (SGJ) for palliation of malignant GOO. METHODS: Searches of electronic databases were performed to identify studies comparing EUS-GE versus DS and/or SGJ for palliative treatment of GOO. Outcomes included technical and clinical success, severe adverse events (SAEs), rate of stent obstruction (including tumor ingrowth), length of hospital stay (LOS), reintervention, and 30-day all-cause mortality. Differences in dichotomous and continuous outcomes were reported as risk difference and mean difference, respectively. RESULTS: Seven studies (n = 513 patients) were included. When compared to DS placement, EUS-GE was associated with a higher clinical success, fewer SAEs, decreased stent obstruction, lower rate of tumor ingrowth, and decreased need for reintervention. Compared to SGJ, EUS-GE was associated with a lower technical success; however, LOS was significantly decreased. All other outcomes including clinical success, SAEs, reintervention rate, and 30-day mortality were not significantly different between an EUS-guided versus surgical approach. CONCLUSIONS: EUS-GE was associated with significantly improved outcomes compared to DS placement for palliative treatment of malignant GOO. Despite SGJ possessing a higher technical success compared to EUS-GE, LOS was significantly longer with no difference in clinical success or rate of adverse events.

TC-325 hemostatic powder versus current standard of care in managing malignant GI bleeding: a pilot randomized clinical trial.

BACKGROUND AND AIMS: TC-325 (Hemospray; Cook Medical, Winston-Salem, NC, USA), an endoscopic hemostatic powder, exhibits possible benefits in patients with malignant GI bleeding. Our aim is to assess feasibility and determine estimates of efficacy of TC-325 compared with standard of care (SOC) in terms of initial hemostasis and recurrent bleeding rates in comparable groups of patients with malignant GI bleeding. METHODS: Adult patients presenting with acute malignant upper or lower GI bleeding were randomized to TC-325 or SOC. Measured outcomes included feasibility of recruitment and randomization in the urgent care setting, immediate hemostasis, recurrent bleeding, need for additional treatment modalities, and mortality. RESULTS: A preplanned 20 patients (upper GI source in 85%) were randomized 1:1 to TC-325 or SOC (25% women, age 67.2 ± 15.9 years, oozing in 95%) over 20 months. Immediate hemostasis was achieved in 90% of patients treated initially with TC-325 versus 40% in the SOC group (P = .057). Overall, 83.3% crossed over to TC-325, with hemostasis then achieved at index endoscopy in 80%. Overall, hemostasis at index endoscopy (before or after crossover) was obtained in 87.7% of patients treated with TC-325. Recurrent bleeding over the next 180 days was 20% in the TC-325 group compared with 60% in the SOC group (P = .170). CONCLUSIONS: This pilot trial demonstrates the feasibility of TC-325 in malignant GI bleeding and provides results to help inform a larger randomized trial. Although not powered for such, results suggest that use of TC-325 is a very promising modality in malignant GI bleeding in achieving immediate hemostasis and may even result in decreased subsequent recurrent bleeding. (Clinical trial registration number: NCT02135627.).

Prevalence of metastasis and survival of 788 patients with T1 rectal carcinoid tumors.

BACKGROUND AND AIMS: Prevalence of rectal carcinoids is increasing, partly because of increased colorectal cancer screening. Local excision (endoscopic or transanal excision) is usually performed for small (<1-2 cm) rectal carcinoids, but data on clinical outcomes from large population-based U.S. studies are lacking. The aims of this study were to determine the prevalence of metastasis of resected small rectal carcinoid tumors using a large national cancer database and to evaluate the long-term survival of patients after local resection as compared with radical surgery. METHODS: The Surveillance Epidemiology and End Results database was used to identify 788 patients with rectal T1 carcinoids <2 cm in size. Prevalence of metastases at initial diagnosis and risk factors for metastases were analyzed. Cancer-specific survival (CSS) was calculated. RESULTS: A total of 727 patients (92.3%) had tumors ≤10 mm in diameter and 61 (7.7%) had tumors 11 to 19 mm. Overall, 12 patients (1.5%) had metastasis at the time of diagnosis with prevalence of 1.1% in lesions ≤10 mm and 6.6% in lesions 11 to 19 mm (P = .01). Survival of patients with T1 rectal carcinoids without metastasis was significantly better than those with metastasis (5-year CSS of 100% vs 78%, P < .001). Of 559 patients with T1N0M0 rectal carcinoids ≤10 mm, 5-year CSS was 100% in both groups who underwent local excision and those who underwent radical surgery. CONCLUSIONS: Larger T1 rectal carcinoid tumors (11-19 mm) have significantly higher risk of lymph node metastases compared with those ≤10 mm. Survival is worse with metastatic disease. Local therapy is adequate for T1N0M0 rectal carcinoids ≤10 mm in size with excellent long-term outcomes.

Lumen-apposing stents versus plastic stents in the management of pancreatic pseudocysts: a large, comparative, international, multicenter study.

BACKGROUND: Larger caliber lumen-apposing stents (LAMSs) have been increasingly used in the management of pancreatic fluid collections, specifically when solid debris is present; however, their advantages over smaller caliber plastic stents in the management of pancreatic pseudocysts are unclear. The aim of this study was to investigate the safety and efficacy of LAMS specifically in the management of pancreatic pseudocysts compared with double-pigtail plastic stents (DPPSs). METHODS: We performed a multicenter, international, retrospective study between January 2012 and August 2016. A total of 205 patients with a diagnosis of pancreatic pseudocysts were included, 80 patients received LAMSs and 125 received DPPSs. Measured outcomes included clinical success, technical success, adverse events, stent dysfunction, pancreatic pseudocyst recurrence, and need for surgery. RESULTS: Technical success was similar between the LAMS and the DPPS groups (97.5 % vs. 99.2 %; P = 0.32). Clinical success was higher for LAMSs than for DPPSs (96.3 % vs. 87.2 %; P = 0.03). While the need for surgery was similar between the two groups (1.3 % vs. 4.9 %, respectively; P = 0.17), the use of percutaneous drainage was significantly lower in the LAMS group (1.3 % vs. 8.8 %; P = 0.03). At 6-month follow-up, the recurrence rate was similar between the groups (6.7 % vs 18.8 %, respectively; P = 0.12). The rate of adverse events was significantly higher in the DPPS group (7.5 % vs. 17.6 %; P = 0.04). There was no difference in post-procedure mean length of hospital stay (6.3 days [standard deviation 27.9] vs. 3.7 days [5.7]; P = 0.31). CONCLUSION: When compared to DPPSs, LAMSs are a safe, feasible, and effective modality for the treatment of pancreatic pseudocysts and are associated with a higher rate of clinical success, shorter procedure time, less need for percutaneous interventions, and a lower overall rate of adverse events.

Efficacy and Safety of Digital Single-Operator Cholangioscopy for Difficult Biliary Stones.

BACKGROUND & AIMS: It is not clear whether digital single-operator cholangioscopy (D-SOC) with electrohydraulic and laser lithotripsy is effective in removal of difficult biliary stones. We investigated the safety and efficacy of D-SOC with electrohydraulic and laser lithotripsy in an international, multicenter study of patients with difficult biliary stones. METHODS: We performed a retrospective analysis of 407 patients (60.4% female; mean age, 64.2 years) who underwent D-SOC for difficult biliary stones at 22 tertiary centers in the United States, United Kingdom, or Korea from February 2015 through December 2016; 306 patients underwent electrohydraulic lithotripsy and 101 (24.8%) underwent laser lithotripsy. Univariate and multivariable analyses were performed to identify factors associated with technical failure and the need for more than 1 D-SOC electrohydraulic or laser lithotripsy session to clear the bile duct. RESULTS: The mean procedure time was longer in the electrohydraulic lithotripsy group (73.9 minutes) than in the laser lithotripsy group (49.9 minutes; P < .001). Ducts were completely cleared (technical success) in 97.3% of patients (96.7% of patients with electrohydraulic lithotripsy vs 99% patients with laser lithotripsy; P = .31). Ducts were cleared in a single session in 77.4% of patients (74.5% by electrohydraulic lithotripsy and 86.1% by laser lithotripsy; P = .20). Electrohydraulic or laser lithotripsy failed in 11 patients (2.7%); 8 patients were treated by surgery. Adverse events occurred in 3.7% patients and the stone was incompletely removed from 6.6% of patients. On multivariable analysis, difficult anatomy or cannulation (duodenal diverticula or altered anatomy) correlated with technical failure (odds ratio, 5.18; 95% confidence interval, 1.26-21.2; P = .02). Procedure time increased odds of more than 1 session of D-SOC electrohydraulic or laser lithotripsy (odds ratio, 1.02; 95% confidence interval, 1.01-1.03; P < .001). CONCLUSIONS: In a multicenter, international, retrospective analysis, we found D-SOC with electrohydraulic or laser lithotripsy to be effective and safe in more than 95% of patients with difficult biliary stones. Fewer than 5% of patients require additional treatment with surgery and/or extracorporeal shockwave lithotripsy to clear the duct.

Current role of endoscopic pancreatoscopy.

PURPOSE OF REVIEW: To provide an overview of the field of pancreatoscopy and to summarize the data informing its clinical utility. RECENT FINDINGS: Regarding the technological advance of pancreatoscopy, recent studies are the first to report the use of digital, single-operator pancreatoscopy (SpyGlass DS; Boston Scientific, Natick, MA). New data on the use of preoperative pancreatoscopy offer promising results for the potential to optimize treatment of intraductal papillary mucinous neoplasms and to differentiate between benign and malignant pancreatic strictures. Finally, there has been accumulating evidence for the use of pancreatoscopy-guided lithotripsy for the management of painful chronic calcific pancreatitis. SUMMARY: Endoscopic pancreatoscopy offers the advantage of direct visualization of the pancreatic duct, allowing for optimal macroscopic assessment, targeted tissue acquisition and guided therapies such as lithotripsy of pancreatic duct stones. The data informing some aspects remain limited, but the accumulating literature forms our understanding of the current and future role of pancreatoscopy in the management of pancreatic disease.

Cost-effectiveness analysis comparing lumen-apposing metal stents with plastic stents in the management of pancreatic walled-off necrosis.

BACKGROUND AND AIMS: EUS-guided transmural drainage is effective in the management of pancreatic walled-off necrosis (WON). A lumen-apposing metal stent (LAMS) has recently been developed specifically for the drainage of pancreatic fluid collections that shows promising results. However, no cost-effectiveness data have been published in comparison with endoscopic drainage with traditional plastic stents (PSs). Our aim here was to compare the cost-effectiveness of LAMSs to PSs in the management of WON. METHODS: A decision tree was developed to assess both LAMSs and PSs over a 6-month time horizon. For each strategy, after the insertion of the respective stents, patients were followed for subsequent need for direct endoscopic necrosectomy, adverse events requiring unplanned endoscopy, percutaneous drainage (PCD), or surgery using probabilities obtained from the literature. The unit of effectiveness was defined as successful endoscopic drainage without the need for PCD or surgery. Costs in 2016 U.S.$ were based on inpatient institutional costs. Sensitivity analyses were performed. An a priori willingness-to-pay threshold of U.S.$50,000 was established. RESULTS: LAMSs were found to be more efficacious than PSs, with 92% and 84%, respectively, of the patients achieving successful endoscopic drainage of WON. LAMSs, however, were more costly: the average cost per patient of U.S.$20,029 compared with U.S.$15,941 for PSs. The incremental cost-effectiveness ratio favored LAMSs at U.S.$49,214 per additional patient successfully treated. Sensitivity analyses confirmed the robustness of the results. CONCLUSION: LAMSs are more effective but also more costly than PSs in managing WON. Data from high-quality, adequately controlled, prospective, randomized trials are needed to confirm our findings.

An international, multicenter, comparative trial of EUS-guided gastrogastrostomy-assisted ERCP versus enteroscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy.

BACKGROUND AND AIMS: ERCP is challenging in patients with Roux-en-Y gastric bypass (RYGB) anatomy. EUS-guided gastrogastrostomy (GG) creation is a promising novel technique to access the excluded stomach to facilitate conventional ERCP. We aimed to compare procedural outcomes and adverse events (AEs) between EUS-guided GG-assisted ERCP (EUS-GG-ERCP) and enteroscopy-assisted ERCP (e-ERCP) in patients with RYGB. METHODS: Patients with RYGB anatomy who underwent EUS-GG-ERCP or e-ERCP between 2014 and 2016 at 5 tertiary centers were included. The primary outcome was technical success of ERCP, defined as successful cannulation of the selected duct with successful intervention as intended. Secondary outcomes included total procedural time (in the EUS-GG group, total procedural time included EUS-GG creation plus ERCP procedure time), length of hospital stay, and rate/severity of AEs graded according to the American Society for Gastrointestinal Endoscopy lexicon. RESULTS: A total of 60 patients (mean age, 57.2 ± 13.2; 75% women) were included, of whom 30 (50%) underwent EUS-GG-ERCP and 30 (50%) underwent e-ERCP (double-balloon enteroscope ERCP, 19; single-balloon enteroscope ERCP, 11). The technical success rate was significantly higher in the EUS-GG-ERCP versus the e-ERCP group (100% vs 60.0%, P < .001). Total procedure time was significantly shorter in patients who underwent EUS-GG-ERCP (49.8 minutes vs 90.7 minutes, P < .001). Postprocedure median length of hospitalization was shorter in the EUS-GG group (1 vs 10.5 days, P = .02). Rate of AEs was similar in both groups (10% vs 6.7%, P = 1). CONCLUSIONS: EUS-GG-ERCP may be superior to e-ERCP in patients with RYGB anatomy in terms of a higher technical success and shorter procedural times and offers a similar safety profile.