Background:Biliary cannulation during endoscopic retrograde cholangiopancreatography (ERCP) remains a critical yet challenging step, particularly in patients with a naïve papilla. The European Society of Gastrointestinal Endoscopy (ESGE) proposed a stepwise algorithm to guide cannulation strategies, but its real-world applicability and outcomes have not been systematically evaluated. This study aimed to assess the effectiveness and safety of ESGE algorithm-guided biliary cannulation during ERCP in a multicenter Italian cohort. Methods:This was a prospective observational study conducted across 11 Italian centers. Consecutive patients undergoing ERCP with naïve papilla were enrolled. Cannulation strategies were categorized based on adherence to the ESGE algorithm. Results:A total of 1435 patients were included and 1086 (75.7%) procedures adhered to the ESGE algorithm. Compared with nonadherence, adherence to the ESGE algorithm resulted in significantly higher biliary cannulation success (98.6% vs. 78.8%; P < 0.001) and shorter procedure duration (median 21 vs. 35 minutes; P < 0.001). Among difficult cannulation cases, success remained higher in the ESGE adherence group (93.1% vs. 78.8%; P < 0.001). At multivariable analyses, factors significantly associated with successful cannulation were adherence to the ESGE algorithm, prone position, degree of ERCP difficulty, and use of short guidewire. Rates of post-ERCP pancreatitis were comparable overall, but moderate-to-severe pancreatitis and perforation were less frequent in the ESGE adherence group. Conclusions:Adherence to the ESGE cannulation algorithm was feasible and was associated with higher cannulation success during ERCP.
Objectives Here we report a rare case of a rectal mixed adenoma-neuroendocrine lesion in which endoscopic submucosal dissection (ESD) proved essential for diagnosis by uncovering an unexpected high-grade neuroendocrine component within a colorectal adenoma.Case presentation A 64-year-old woman underwent a screening colonoscopy following a positive fecal occult blood test. Endoscopic evaluation identified a 25 & times; 20 mm laterally spreading tumor in the distal rectum. ESD was successfully performed, achieving complete en bloc resection. Histological analysis demonstrated a tubular adenoma with high-grade dysplasia containing a large-cell neuroendocrine carcinoma (NEC) counterpart, consistent with a mixed adenona-neuroendocrine lesion. Despite R0 resection and disease staging proving a localized neoplasm (T1N0M0), since lymphatic invasion and the presence of an NEC component were identified, the patient was referred for surgical resection.Conclusions This case highlights the diagnostic value of ESD in rectal lesions, not only as a therapeutic approach but also as a critical tool for achieving optimal specimen quality and identifying unexpected aggressive histology with major implications for staging and subsequent management.
Tofacitinib, filgotinib, and upadacitinib are Janus kinase inhibitors (JAKis) available for ulcerative colitis (UC) refractory or intolerant to at least one advanced therapy; their comparative effectiveness in clinical practice remains uncertain. We conducted a multicenter retrospective study including adult UC patients initiating tofacitinib, filgotinib, or upadacitinib (September 2020–June 2025). Clinical remission (partial Mayo score ≤ 1), steroid-free clinical remission, biochemical remission, and endoscopic remission (Mayo endoscopic score = 0) were assessed at predefined time-points. Baseline differences were controlled using inverse probability of treatment weighting (IPTW), and time-to-event and longitudinal analyses were performed. After IPTW, the pseudo-population included 627 patients (tofacitinib = 179, filgotinib = 138, upadacitinib = 310). In the weighted cohort, clinical remission probabilities at weeks 8, 24, and 52 were 17.5
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.
Tumor necrosis factor-alpha (TNF-α) inhibitors, including infliximab, have redefined the treatment of inflammatory bowel diseases (IBD) such as ulcerative colitis (UC). Despite their efficacy, these agents are associated with rare but serious adverse events, including drug-induced interstitial lung disease (D-ILD). We report a case of infliximab-induced ILD in a 63-year-old male undergoing treatment for UC. The patient presented with fever, dyspnea, and a miliary hypersensitivity pattern on imaging. Infectious causes were excluded, and drug-induced pulmonary toxicity was diagnosed. Discontinuation of infliximab and appropriate management led to gradual clinical improvement. This case highlights the importance of early recognition and management of pulmonary complications associated with TNF-α inhibitors. Given that UC itself and other autoimmune diseases can predispose patients to ILD, we also explore the role of disease activity and additional risk factors, including prior exposure to 5-aminosalicylic acid-based medications. Endoscopic disease activity, fecal calprotectin levels, autoimmune markers (ANA, ENA, ANCA), and bronchoalveolar lavage results are provided to further elucidate the diagnostic process.
BACKGROUND:Guidelines recommend leaving in situ rectosigmoid polyps diagnosed during colonoscopy that are 5 mm or smaller if the endoscopist optically predicts them to be non-neoplastic. However, no randomised controlled trial has been done to examine the efficacy and safety of this strategy. METHODS:This open-label, multicentre, non-inferiority, randomised controlled trial enrolled adults age 18 years or older undergoing colonoscopy for screening, surveillance, or clinical indications across four Italian centres. Eligible patients were randomised 1:1 (with stratification by patient sex, age, and previous adenoma removal) via a central web-based system, to either the leave-in-situ group, in which endoscopists could leave non-neoplastic lesions in place after optical diagnosis, or the resect-all group, in which all detected polyps were systematically removed, regardless of optical diagnosis. Patients and endoscopists were not masked to group allocation but pathologists and investigators assessing outcomes were masked. All procedures in both groups were done with the assistance of a computer-aided detection and diagnosis system. Endoscopists optically diagnosed lesions through a combination of white light, blue light, and computer-aided detection. The primary outcome was the adenoma detection rate (ADR), defined as the proportion of participants with at least one adenoma detected (per-patient analysis), assessed by intention-to-treat, to determine whether the leave-in-situ strategy was non-inferior to the resect-all approach, with an absolute 10% non-inferiority margin. This trial was registered with ClinicalTrials.gov (NCT05500248) and is completed. FINDINGS:Between Oct 1, 2022, and April 30, 2024, 1147 patients were recruited and 895 patients (507 [57%] females, 388 [43%] males, mean age 61·1 years [SD 9·8]) were randomly assigned to either the leave-in-situ group (n=441) or resect-all group (n=454). 197 adenomas or colorectal cancers were detected in the leave-in-situ group and 211 in the resect-all group; the ADR was 44·7% (95% CI 40·4 to 49·5) in the leave-in-situ group and 46·5% (41·8 to 51·2) in the resect-all group (absolute difference -1·8 percentage points, 95% CI -8·9 to 4·9; pnon-inferiority=0·013). No colonoscopy-related complications, including perforation and bleeding, were reported in either group. INTERPRETATION:The leave-in-situ strategy through optical diagnosis with computer-assisted diagnosis support does not reduce oncological safety of colonoscopy, as measured by ADR. By reducing unnecessary polypectomies, this strategy could be considered as an attractive option in colonoscopy practice. FUNDING:European Society of Gastrointestinal Endoscopy.
Colonoscopy is a cornerstone of colorectal cancer (CRC) prevention, with adenoma detection rate (ADR) serving as a critical quality metric. However, substantial variability in ADR persists across operators, and a significant proportion of colorectal neoplasia—particularly flat, serrated, and right-sided lesions—continues to be missed. These limitations are often attributable to suboptimal mucosal exposure, especially in anatomical regions hidden behind haustral folds and flexures.To address this, a variety of mechanical auxiliary devices—collectively termed behind-folds visualizing techniques and technologies (BFTs)—have been developed to enhance mucosal exposure during withdrawal. These include both add-on devices (e.g., caps, Endocuff, EndoRings) and integrated technologies (e.g., G-EYE, FUSE, Third Eye), each with varying levels of evidence and practicality.This review critically appraises current data on BFTs, highlighting their efficacy in improving ADR, particularly among endoscopists with lower baseline performance. Meta-analyses suggest that simple, low-cost devices such as Endocuff and caps offer the most favorable balance of effectiveness, accessibility, and ease of use. Furthermore, emerging data indicate that combining mechanical exposure devices with artificial intelligence-based systems may yield additive benefits.BFTs represent pragmatic tools to optimize colonoscopy quality and reduce post-colonoscopy CRC. Their selective implementation—especially in low-performing settings—should be considered a key component of modern endoscopic practice.
Background: Upadacitinib (UPA), a selective anti-JAK1 agent, obtained refundability from the Italian National Health System in July 2023 for its use in patients with ulcerative colitis (UC) refractory to other therapies, including anti-TNF-α, anti-integrins, and ustekinumab. At present, no Italian data are available about its effectiveness and safety in the real world. Methods: A retrospective assessment of clinical and endoscopic activity was performed according to the Mayo score. The primary endpoints were to evaluate the effectiveness and safety of UPA. Results: We included 202 consecutive UC patients (M/F 119/83, median age 42). The clinical remission and clinical response rates were 45.5% (92/202) and 63.5% (128/202), respectively, at 8 weeks and 60.2% and 81.7%, respectively, at the end of the follow-up. Clinical remission was achieved more frequently when UPA was used as a first-line rather than a second-/third-line treatment (p = 0.609). Mucosal healing was reported in 84.6% of patients at the median follow-up time. Adverse events occurred in six patients (2.5%), whereas four patients (2%) underwent colectomy. Conclusions: This large real-world study shows that UPA is an effective and safe treatment for UC patients.
Infliximab, a monoclonal antibody targeting tumor necrosis factor-alpha (TNF-α), is widely used in treating inflammatory bowel diseases (IBD), including ulcerative colitis (UC). While generally well-tolerated, infliximab is associated with rare but significant adverse effects, including autoimmune hemolytic anemia (AIHA). This report describes the case of a 54-year-old male diagnosed with UC, who developed hemolytic anemia secondary to infliximab therapy after 1 year of treatment. During the infusion preceding the onset of anemia, the patient experienced a severe infusion reaction characterized by urticaria, bronchospasm, chills, fever, and pulsating headache. Laboratory findings confirmed hemolytic anemia with a positive direct and negative indirect Coombs tests. The patient responded well to corticosteroid therapy (prednisone at 1 mg/kg/day for 30 days) and stopping anti-TNF-α, with hemoglobin levels improving from 7.2 g/dL at presentation to 14.6 g/dL after 1 month. AIHA should be considered an uncommon but serious complication of infliximab therapy, necessitating careful monitoring, especially in patients treated for gastrointestinal indications. This case underscores the importance of recognizing and managing infusion-related complications of biologic therapies.
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.
Background:Accurate polyp size estimation during colonoscopy is crucial for clinical decision making, follow-up, and implementation of cost-saving strategies. Objective sizing methods are lacking, and interobserver variability is high. This prospective, multicenter, study evaluated the accuracy of a novel artificial intelligence (AI)-based algorithm for polyp size estimation. Methods:Patient aged ≥18 years undergoing colonoscopy for colorectal cancer (CRC) screening or surveillance were enrolled across three centers. Polyp size was initially assessed by operators using forceps/snare comparison (ground truth). Procedures were recorded, and AI-based polyp size estimates were obtained offline. The primary outcome was AI accuracy in size class determination (diminutive ≤5 mm, small 6–9 mm, large ≥10 mm). Secondary outcomes included size estimation in mm and impact on clinical management strategies. Results:Among 465 polyps (307 diminutive, 107 small, 51 large) from 217 patients (mean age 61.9 [SD 10.4] years, 51.6% female), AI accuracy for size class determination was 85.8% (95%CI 82.5–88.8). Accuracy for diminutive, small, and large polyps was 93.3%, 74.6%, and 55.1%, respectively. The AI tool assigned 90.8% of patients to correct surveillance intervals and achieved mean absolute error of 1.13 mm and root mean square error of 1.40 mm for polyps ≤10 mm. Conclusions:The AI model performed similarly to expert endoscopists in clinically relevant size-related outcomes, potentially improving the accuracy and efficiency of CRC screening.