BACKGROUND:Endoscopic retrograde cholangiopancreatography (ERCP) quality measures are critical to define standards of care and guide improvement strategies. AIMS:This study aimed to determine risk-adjusted outcomes following ERCP for malignant biliary obstruction(MBO). METHODS:Using an intention-to-treat approach, we analyzed data from a multicenter database including 23 Italian hospitals (2017-2022). Inter-center heterogeneity was assessed with I² statistic. To account for case-mix confounding, multivariable mixed-effects models estimated risk-adjusted outcomes. RESULTS:Clinical and procedural characteristics showed considerable heterogeneity across centers (I²>75%). In the intention-to-treat cohort (n = 3148), the risk-adjusted technical success rate was 91.3%; the intraclass correlation coefficient (ICC) was 11.6%, suggesting that 11.6% of the outcome variance resides at the hospital level. In the per-successful-procedure cohort (n = 2665), the risk-adjusted technical success rate was 91.3% (ICC 22.7%). Post-ERCP pancreatitis occurred in 5.4% (ICC 12.9%), additional ERCPs were required in 23.7% (ICC 4.1%), and 30-day mortality was 4.2%. Treatment in high-volume hospitals (>350ERCPs/year) was associated with lower mortality(p = 0.001). CONCLUSIONS:Most variability in ERCP outcomes across hospitals reflects differences in patient selection and technical strategies. After risk adjustment, outcomes were similar across centers, supporting consistent quality of care. This study provides exploratory, risk-adjusted benchmarks derived from real-world practice for ERCP in MBO and supports their use for quality monitoring and referral planning.

BACKGROUND & AIMS:Postprocedural pancreatitis is the most common adverse event (AE) associated with endoscopic retrograde cholangiopancreatography (ERCP). Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) using a lumen-apposing metal stent is emerging as a promising approach for managing malignant distal biliary obstruction, offering the potential to lower the risk of postprocedural pancreatitis. METHODS:This was a multicenter randomized study, enrolling consecutive patients admitted for obstructive jaundice due to malignant distal biliary obstruction with dilated common bile duct (≥15 mm). Patients were randomly allocated to receive EUS-CDS or ERCP for primary biliary drainage. This was a superiority trial with postprocedural acute pancreatitis as primary outcome. Other outcomes included technical success, clinical success, AEs, 6-month stent patency rate, and overall survival. Analyses were performed according to intention-to-treat principles. RESULTS:Between April 2021 and October 2023, 220 patients were enrolled in the study (EUS-CDS, 111; ERCP, 109). EUS-CDS group showed a lower risk for postprocedural acute pancreatitis (1.8% in EUS-CDS vs 7.3% in ERCP; relative risk, 0.25; 95% confidence interval, 0.07-0.88). Technical success was achieved in 94.6% in EUS-CDS group vs 78.9% ERCP group (P < .001), in a mean procedural time of 13.5 ± 11.6 minutes and 24.7 ± 14.9 minutes, respectively (P <.001). No differences were found in other AEs (19.8% in EUS-CDS vs 21.1% in ERCP; relative risk, 0.94; 95% confidence interval, 0.56-1.58), clinical success, stent patency, or overall mortality. CONCLUSIONS:EUS-CDS is superior to ERCP in reducing postprocedural acute pancreatitis risk. However, the overall risk of AEs was not significantly different and warrants further investigation. Additionally EUS-CDS showed improved technical success and comparable clinical efficacy. These results support a potential role of EUS-CDS as primary approach in selected patients with dilated common bile duct (ClinicalTrials.gov, Number: NCT04099862).

INTRODUCTION:Endoscopic papillary large balloon dilation (EPLBD) is currently considered the first-line treatment for difficult biliary stones (DBS). However, EPLBD alters the sphincter of Oddi's function, potentially exposing patients to cholangitis. To date, few data are available on the long-term consequences of EPLBD. AIMS AND METHODS:The aim of this study is to explore the long-term complications of EPLBD with endoscopic sphincterotomy (ES) in terms of cholangitis and biliary recurrence. Adult patients who underwent EPLBD with ES with complete bile duct clearance were included in the study. Primary outcome of the study was the rate of cholangitis; secondary outcome was biliary recurrence after EPLBD. RESULTS:1221 patients with a median age of 77 years old (IQR 68-84) were included in the study. One hundred and forty-three patients (11.7%) experienced at least one episode of cholangitis with a cumulative 1-, 3-, and 5-year risk of cholangitis of 7.3%, 13.2%, and 15.3%, respectively. Cholangitis was caused by stones recurrence in 71.6% of cases, whereas alithiasic cholangitis was experienced in 22.9% of patients. The estimated 1-, 3-, and 5-year risk of biliary recurrence was 9.7%, 16.7%, and 21.8%, respectively. In multivariate cox regression analysis, ≥ 2 previous ERCPs before EPLBD were independently associated with increased risk of cholangitis and biliary recurrence. CONCLUSIONS:Cholangitis and biliary recurrence are not an infrequent complication after EPLBD. Biliary stone recurrence may be a consequence of SO dysfunction after EPLBD with ES; further comparative data are needed to evaluate whether EPLBD with ES is directly associated with long-term complications.

In the published publication [...]

BACKGROUND:Ampullary neuroendocrine tumors (NETs) are extremely rare, representing 0.3%-1% of gastrointestinal NETs and less than 2% of periampullary cancers. Due to their rarity, there is limited data on their natural history, management, and outcomes. Current European Neuroendocrine Tumor Society guidelines (2023) recommend pancreaticoduodenectomy (PD) as the standard treatment. However, this approach is invasive and associated with high morbidity and mortality. Emerging evidence suggests that endoscopic papillectomy (EP) could be a viable alternative in selected cases. This retrospective multicenter study aimed to evaluate the feasibility and outcomes of endoscopic resection for ampullary NETs. METHODS:This retrospective case series included 14 patients who underwent EP for ampullary NETs between 2011 and 2022 across three Italian tertiary centers. Pre-procedural evaluation was performed following European Society of Gastrointestinal Endoscopy guidelines. Endoscopic papillectomy was performed under monitored sedation, using standard snares for en bloc resection. Follow-up endoscopy was conducted at a median of 3 months. Primary outcomes included complete resection (R0) and recurrence rates; secondary outcomes focused on adverse events. RESULTS:Fourteen patients (median age: 62.5 years; 50% male) were included. Median tumor size was 18 mm. In 12 out of 14 cases, ampullary NETs were diagnosed only after endoscopic resection. Post-resection histology identified 8 G1 NETs (Ki-67 1%) and 6 G2 NETs (Ki-67 5%). Complete resection was achieved in 11 cases (78.6%). Among 3 incomplete resections, 2 were managed surgically, while 1 was followed up without recurrence. Residual disease was detected in 3 patients: 2 were managed endoscopically, and 1 required surgery. No recurrences occurred during a median follow-up of 14.5 months. Adverse events occurred in 42.9% of patients, including 5 cases of bleeding and 1 case of mild pancreatitis, all resolved without major sequelae. Median hospital stay was 2.5 days. CONCLUSIONS:Our findings suggest that EP offers a promising alternative to surgery in selected patients with ampullary NETs. Endoscopic resection was associated with high rates of R0 and favorable short-term outcomes, with effective endoscopic management of residual disease and procedure-related adverse events. Consistent post-procedural surveillance remains essential to detect residual or recurrent disease. Larger prospective studies are warranted to refine patient selection criteria, optimize protocols, and establish the long-term efficacy.

BACKGROUND:Little is known about the genetic background of individuals with familial pancreatic cancer (PC). Integrating germline testing into surveillance may uncover previously unrecognized hereditary susceptibility and expand prevention strategies beyond BRCA testing alone. This study evaluated the genetic landscape of high-risk individuals due to familiality (HRI-FHs) enrolled in a national surveillance program. METHODS:Five hundred HRI-FHs from seven centers underwent surveillance and germline testing with a 41-gene NGS panel. Pathogenic/likely pathogenic variants (PGVs) and variants of unknown significance (VUS) were identified and correlated with clinical and imaging findings. RESULTS:Overall, forty-four (8.8%) out of 500 HRI-FHs carried at least one PGV, including 3.4% in high-penetrance genes (ATM, BRCA1/2, PALB2, BRIP1). Notably, 8 out of 17 (47%) of ATM, BRCA1/2, PALB2 carriers would not have met the national testing criteria based solely on their family history. An additional 5.4% (27/500) carried PGVs in genes linked to other hereditary conditions (CFTR, MUTYH, CTRC, SPINK1, APC), and 39.6% harbored at least one VUS. PGV status, age, and female gender were independent predictors of radiological abnormalities. Two PCs were diagnosed, both in mutation-negative individuals. DISCUSSION:Integrating germline testing into surveillance redefines the management of familial PC. It uncovers hereditary susceptibility beyond classical criteria and supports cascade testing. PC also arises in mutation-negative HRI. #NCT05724992.

BACKGROUND:Therapeutic endoscopic ultrasound (TEUS) has expanded into a broad procedural platform including access, delivery, measurement, ablation, drainage, and anastomoses. Nevertheless, TEUS lacks a shared procedural complexity classification. METHODS:Within an International initiative of the Next Generation EUS group, a dedicated task force developed a four-level classification, subsequently evaluated through Delphi methodology. The classification considered target stability and size, accessory exchange, adverse event profile, technical standardization, and prerequisite skills. To support and contextualize the consensus output, a targeted narrative review of published evidence was performed, analyzing technical success, clinical success, adverse events, learning curves, and procedural modifiers across major TEUS procedures. RESULTS:The Delphi-informed classification achieved 92.7% agreement among 106 respondents. Level 1 includes procedures mainly based on endosonographic skills, such as EUS-guided ablation and placement of Lumen Apposing Metal Stents (LAMS) within large fluid collections; Level 2 includes EUS-guided choledochoduodenostomy and gallbladder drainage with LAMS and fluid collection drainage with multistep plastic stenting; Level 3 includes more demanding fluoroscopy-based interventions, such as EUS-guided hepaticogastrostomy, rendezvous, and upper gastrointestinal anastomoses; Level 4 includes procedures with advanced complexity and limited standardization, such as EUS-directed ERCP, pancreatic duct drainage, and small/large bowel anastomoses. This article discusses the rationale, clinical utility, and training implications of this classification. CONCLUSIONS:This 4-level Delphi-informed classification for TEUS complexity achieved high expert agreement and provides a pragmatic framework to support training pathways, case selection, outcome interpretation, referral, and credentialing processes.

BACKGROUND:Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) and related EUS-guided anastomoses are increasingly used for gastric outlet obstruction and other complex gastrointestinal scenarios, but indications, technical standards, and peri-procedural care remain heterogeneous. METHODS:An international panel of 66 experts (i-EUS) developed statements using a structured modified Delphi process. Literature searches were performed up to 30 April 2025. Comparative PICO-framed questions with extractable evidence underwent structured evidence synthesis and GRADE assessment, whereas procedural, technical, and organizational statements were classified as consensus based. Consensus was predefined as ≥85% agreement. RESULTS:Of 25 draft statements, 20 reached consensus and 5 did not. Six endorsed statements were GRADE-based and 14 were consensus-based. For malignant gastric outlet obstruction, EUS-GE was recommended over duodenal stenting because of greater durability and fewer reinterventions and suggested over surgical bypass because of comparable efficacy and fewer overall adverse events. Consensus-based statements addressed expert-centre requirements, supervised training, catheter-based target-loop distension, freehand LAMS deployment, fluoroscopy availability, antithrombotic management, refeeding, post-procedural imaging, recurrent obstruction, and misdeployment. Conditional recommendations addressed LAMS diameter selection, selected benign gastric outlet obstruction, EDGE/EDGI in Roux-en-Y gastric bypass, and malignant afferent limb syndrome. No formal recommendation was issued for peritoneal carcinomatosis, routine tracheal intubation, antibiotic prophylaxis, EDEE in non-RYGB anatomy, or EUS-guided colo-enterostomy. CONCLUSIONS:These i-EUS recommendations provide a practical framework for EUS-GE and related anastomoses in expert settings. The evidence base remains limited, and prospective comparative studies are needed to refine patient selection, training requirements, and long-term outcomes.

BACKGROUND:Microbial communities were recently revealed in the biliary tract of pancreaticobiliary disorders. However, evidence is limited and comparative data are lacking. AIMS:We aimed to characterize the biliary microbiota in patients with naïve papilla affected by obstructive jaundice eligible for endoscopic treatment. METHODS:222 consecutive patients undergoing ERCP were prospectively enrolled from July 2022 to August 2023. Bile was sampled before and after sphincterotomy,then stored for cultures and resistance profiles. RESULTS:Pre-sphincterotomy (66,6%) and post-sphincterotomy samples (67,5%) revealed bacterial growth, with similar components. Gram-positive bacteria, as Enterococcus spp, were mainly identified. Age ≥60 years, Charlson Comorbidity Index (CCI) ≥4, fever, ongoing antimicrobial therapy and positive blood cultures were associated with positive bile cultures. Positive C-reactive protein was independently related to positive cultures. Multidrug Resistand (MDR) strains, according to international standardized definition, were detected (18%), with a higher prevalence of ESBL bacteria and E. faecium VRE. Antimicrobial therapy was an independent risk factor for MDR biliary bacteria in the multivariate analysis. Positive cultures, polymicrobial flora, and MDR bacteria were similar in malignant and benign disease. CONCLUSION:Multiple clusters and MDR bacteria were detected in patients with obstructive jaundice. We identified clinical and biochemical risk factors for bacteriobilia and MDR commensals.