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.

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.

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EUS-guided gallbladder drainage (EUS-GBD) has proved to be highly safe and effective in patients with acute cholecystitis at high surgical risk. These findings stimulated the search for populations outside the acute setting, where EUS-GBD performed electively could become a valid therapeutic option. This is a retrospective, multicenter, study involving patients who underwent elective endoscopic gallbladder treatment (EEGBT) in nine referral centers. All patients had a benign gallbladder disease and were judged to be at high surgical risk, with an indication to undergo cholecystectomy. EUS-GBD was performed using LAMSs and followed by intra-gallbladder lithotripsy when necessary. Primary outcome was adverse events (AE) rate; secondary outcomes included technical and clinical success rates and need for additional intracholecystic procedures. Forty-nine patients (mean age 78.7 ± 12.3 years, M/F 22/27) underwent EEGBT over a 2-year period. All patients had ASA score ≥ 3, and a Charlson Comorbidity Index ≥ 5 was present in 71

BACKGROUND:Risankizumab (RZB) is an anti-interleukin 23 (anti-IL-23) approved for the treatment of Crohn disease (CD). STUDY QUESTION:We aimed to evaluate the effectiveness and safety of RZB in the treatment of CD in real-world settings. STUDY DESIGN:We performed a retrospective review of a multicentre consortium of patients with CD treated with RZB. MEASURES AND OUTCOMES:Coprimary outcomes were clinical remission at week 12, 24, and 52 (Harvey-Bradshaw Index score of ≤4), and safety. Secondary outcomes included steroid-free clinical remission, clinical response, and endoscopic remission at 52 weeks. RESULTS:A total of 487 patients were included. The median follow-up was 24 (interquartile range: 16-38) weeks. A total of 372 (76.4%) patients achieved clinical remission at maximal follow-up. According to the treatment line in which RZB was administered, clinical remission occurred in 115/134 (85.8%) patients on second-line therapy, 112/153 (73.2%) on third-line therapy, and 145/200 (72.5%) on fourth-line therapy, with a significant difference ( P = 0.010). Adverse events occurred in 60 patients (12.6%) during follow-up; most of them were mild (50/60, 83.3%). Regarding the secondary outcomes: steroid-free clinical remission was achieved in 342 (71.8%) patients, and clinical response was observed in 443 (91.0%) patients. Six (1.2%) patients underwent surgery during follow-up. Mucosal healing was achieved in 34/67 (50.7%) patients. CONCLUSIONS:In this extensive, real-world study, RZB was effective and well tolerated in an advanced-therapy-exposed population of patients with CD and associated with favorable clinical and endoscopic outcomes.

Background and objectives: Biliary drainage(BD)in distal malignant biliary obstruction(DMBO)is often hampered by difficult biliary cannulation(DBC)during endoscopic retrograde cholangiopancreatography(ERCP). Advanced cannulation techniques(aERCP)may overcome DBC but still fail in up to 15% of cases, increasing the risk of adverse events(AEs). Early endoscopic ultrasound-guided BD(eEUS-BD)is a potential alternative. The aim of this study is to directly compare safety and efficacy of EUS-BD and aERCP. Methods: This is a retrospective, multicentric study(29 centres in United States, Canada, Europe), including patients with DMBO and common bile duct(CBD)diameter >12 mm, treated up to 2024. DBC cases managed with either eEUS-BD or aERCP were analysed. A 1:2 propensity score-matched cohort was generated to ensure comparability, with regression modeling and inverse probability of treatment weighting(IPTW)performed as sensitivity analyses. AEs rate was the primary outcome; secondary outcomes included BD failure and clinical success. Results: Standard cannulation failed in 2066/10,738(19.2%)ERCPs. aERCP and eEUS-BD were attempted in 1733 and 333 cases, respectively. After matching, 313 patients per EUS-BD group and 626 patients per aERCP group were analyzed. AEs occurred in 18.2% of aERCPs and 9.3% of eEUS-BD(p<0.01), with post-procedural pancreatitis the most frequent AE after aERCP(55 cases, 12.0%). Both regression and IPTW confirmed the robustness of these findings on the entire cohort. Technical success was significantly lower with aERCP(82.0% vs. 95.9%, p<0.01), clinical success was comparable(94.5% vs. 96.4%, p=0.89). Conclusions: In patients with DMBO and dilated CBD, eEUS-BD is associated with fewer AEs and higher technical success than aERCP, supporting its role as a safer, more effective option in DBC.

Background and study aims:There is no consensus regarding optimal selection of self-expandable stents (SEMS) for biliary drainage with endoscopic retrograde cholangiopancreatography (ERCP). This study compared stent dysfunction, patient survival, and adverse events in patients with unresectable malignant distal biliary strictures (DBS) treated with ERCP, randomized to partially covered (PC-SEMS) or uncovered (U-SEMS) stents. Patients and methods:A prospective, multicenter, randomized controlled trial was performed in adult patients with DBS (March 2021-February 2023) with 12-month follow-up. Analyses were conducted according to intention-to-treat (ITT) and per-protocol (PP) principles. Procedural and post-procedural outcomes were evaluated using PP analyses and stent patency was evaluated with Kaplan-Meier analysis. Results:Among 261 patients, 130 were randomized to PC-SEMS and 131 to U-SEMS. Baseline features were similar between groups (mean age 73 ± 11 years; 51% male). Most strictures were due to pancreatic adenocarcinoma (75%), and 49% of patients had metastatic disease. Overall, stent dysfunction was comparable (11% vs 14%; P = 0.70). No significant differences were observed in patient survival (108 vs 100 days). A trend toward higher procedure-related complications was noted with PC-SEMS (2% vs 7%; not significant). Conclusions:PC-SEMS and U-SEMS in unresectable DBS showed comparable patency, survival, and stent dysfunction rates, with tumor ingrowth rarely observed and a trend toward more procedure-related complications in PC-SEMS. In this group with limited survival, there was no observed patency advantage with PC-SEMS. Potential benefit of PC-SEMS in populations with longer prognosis warrants further study.

This multicenter retrospective study included patients undergoing EUS-guided GI anastomoses from 2016 to 2023. Indications for EUS-guided anastomosis were GOO, ALS or patients with altered anatomy needing endoscopic interventions. The primary outcome was technical success, while secondary outcomes included clinical success, safety, lumen-apposing metal stent (LAMS) patency, and the need for reinterventions. A total of 216 patients (mean age 64.5 [±13.94] years; 49.1% males) were included. In total, 149 cases (69%) were GOO, 44 (20.4%) cases were bilioenteric anastomotic strictures or lithiasis in altered anatomy, 14 cases (6.5%) were ALS, and 9 patients (4.2%) were for ERCP in altered anatomy after EUS-GG. Overall, EUS-GE was performed in 181 patients (83.8%), EUS-JJ in 44 cases (20.4%), and EUS-GG in 10 (4.6%). Technical success was 94.91%, and clinical success was 93.66%. The adverse event (AE) rate was 11.1%. The reintervention rate was 7.69%. The median follow-up was 85 days. In conclusions, EUS-guided GI anastomoses are technically feasible and safe in both malignant and benign diseases.

Background and Objectives: Gastric cancer (GC) remains a leading cause of cancer mortality worldwide, and the COVID-19 pandemic posed new barriers in diagnosis and management. This study aimed to assess whether pandemic-related healthcare disruptions resulted in more advanced GC stages at presentation. We additionally examined the role of Helicobacter pylori (H. pylori) across non-cardia GC (NCGC) versus cardia GC (CGC) and evaluated the risk factors of upper gastrointestinal (GI) bleeding. Methods: A retrospective cohort of 121 adult patients with GC was enrolled from a tertiary Gastroenterology Unit in Western Romania, spanning pre-pandemic (March 2018–February 2020), pandemic (March 2020–February 2022), and post-pandemic (March 2022–February 2024) periods. Demographic profiles, TNM staging, histopathology, H. pylori status, and clinical outcomes—including GI bleeding—were extracted from medical records. Results: An increase in advanced GC (Stage III–IVB) was noted in the post-pandemic period (69.4% vs. 53.3% pre-pandemic; p = 0.021). H. pylori positivity remained higher in NCGC (70.6%) compared to CGC (44.6%; overall p = 0.041); however, CGC cases showed a rise in H. pylori prevalence post-pandemic (36.4% to 55.6%). One-year mortality was driven by an advanced stage (hazard ratio [HR] = 2.74, p = 0.002), diagnosis during the COVID-19 pandemic (HR = 1.66, p = 0.010), and age ≥70 years (HR = 1.88, p = 0.043). Conclusions: Our findings demonstrate that delayed diagnostic endoscopy correlated with a higher proportion of advanced GC in the post-pandemic phase. H. pylori was strongly linked to NCGC, though CGC showed an increasing trend in H. pylori prevalence. Patients on antithrombotic agents faced increased GI bleeding risks.

Background and Objectives:Helicobacter pylori (H. pylori) infection remains one of the most common chronic bacterial infections worldwide and is associated with a wide range of gastrointestinal disorders, including gastritis, peptic ulcer disease, and gastric cancer. Increasing rates of antibiotic resistance, particularly to clarithromycin and fluoroquinolones, represent a major therapeutic challenge. The objective of this study was to determine the prevalence of resistance-associated mutations in H. pylori-positive gastric biopsy samples from western Romania. Materials and Methods: We conducted a prospective study from January to December 2024, enrolling 138 patients undergoing gastroscopy. Biopsies were collected from the gastric antrum, and H. pylori infection was confirmed using the rapid urease test (RUT). Positive samples were further analyzed with the GenoType HelicoDR assay to detect mutations in the 23S rRNA gene (clarithromycin resistance) and gyrA gene (fluoroquinolone resistance). Clinical, demographic, and endoscopic data were also collected. Results:H. pylori infection was confirmed in 41.3% of the patients (57), of whom 63.2% (36) were treatment-naïve and 36.8% (21) had prior eradication therapy. Among treatment-naïve patients, clarithromycin resistance was identified in 19.4%, whereas previously treated patients showed a markedly higher resistance rate of 47.6% (p = 0.018). All clarithromycin-resistant cases carried the A2147G (23S MUT3) mutation. Fluoroquinolone resistance was present in 13.9% of naïve patients and increased to 23.8% in those with prior eradication therapy, with resistance linked to gyrA mutations at codons 87 (N87K) and 91 (D91 variants). Combined resistance to both antibiotics was observed only in a subset of previously treated patients. Conclusions: Primary resistance to clarithromycin in western Romania exceeds the 15% threshold defined by international guidelines, making clarithromycin-based triple therapy unsuitable as an empirical first-line option. The findings support the use of bismuth quadruple therapy as the preferred empirical regimen in this region. Also, molecular testing proved effective for rapid identification of resistance-associated mutations.

Background/Aims: Real-world data on the use of filgotinib (FILGO) in patients with ulcerative colitis (UC) are limited. This study aims to provide consistent results on the effectiveness and safety of FILGO in treating UC. Methods: A retrospective assessment of clinical and endoscopic activity was conducted in a cohort of patients with UC according to the full Mayo score. The primary co-endpoints of the study were the evaluation of the effectiveness and safety of FILGO. Results: We enrolled 102 patients with a median follow-up of 24 weeks (interquartile range, 8-24 weeks). At 8 weeks and the end of follow-up, clinical remission was achieved by 38 (37.2%) and 47 (46.1%) patients, respectively. Clinical remission was achieved in 13 of 18 patients (72.2%) receiving first-line therapy, 7 of 19 patients (36.8%) receiving second-line therapy, and 27 of 65 patients (41.5%) receiving third-line therapy (P= 0.002). Clinical remission at 8 weeks predicted clinical remission at the end of follow-up (P= 0.021). Age > 40 years (P= 0.046) and being on second- or third-line of treatment (P= 0.005) were negative predictors for clinical remission. Seventy-one patients (69.6%) achieved a clinical response. At endoscopic evaluation, mucosal healing was observed in 18 out of 30 patients (60.0%). Steroid-free remission was present in 38 out of 46 patients (82.6%). Five patients (4.9%) needed colectomy. Adverse events were recorded in 6 patients (5.8%): 2 cases (2%) were severe, requiring discontinuation of FILGO. Conclusions: Our real-world data confirms that FILGO is safe and effective for patients with UC. Its efficacy is significantly improved when used as a first-line treatment.