Abstract Background The Apulian Network for Inflammatory Bowel Disease (AN-IBD) is a prospective observational regional database recently approved by the Ethics Committee in Apulia (Italy), enrolling all IBD patients with an established diagnosis and focusing on the safety and effectiveness of all licensed therapies. We aimed to evaluate the safety profile of IBD therapies registered in patients enrolled in the participating centres and to record the occurring adverse events. Methods The AN-IBD involves 19 centres across Apulia, selected based on their capacity to prescribe advanced IBD therapies. In the six months following the ethical approval, we recorded unselected patients in the database and stratified them by disease type, age, sex and type of treatment. The occurrence of infusion reactions (local and systemic), infections, IBD-related hospitalization, need for colectomy, malignancies, thromboembolic events, and laboratory alterations were recorded. Their severity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results A total of 420 patients were enrolled, consisting of 251 males (59,76%) and 169 females (40,24%), with a median age of 44 years. Among them, 243 (57,86%) were diagnosed with ulcerative colitis, 156 (37,14%) with Crohn’s disease and 21 (5%) with unclassified colitis. Overall, 341 patients (81,19%) were treated with advanced therapy, including biologic therapy and small molecules. A total of 33 (7,85%) adverse events were recorded comprehensively, and most of them were graded as moderate according to the CTCAE. Twenty-three patients were treated with biologic therapy (70%), seven with small molecules (21%), one with immunomodulators (3%) and two with conventional therapy (6%). The most common adverse events were infusion reactions, with fourteen cases recorded (42%), followed by eight cases of infective complications (24%), predominantly due to cytomegalovirus reactivation. Other recorded adverse events included IBD-related surgery (15%), malignancies (9%) and altered liver enzymes (9%). Conclusion These preliminary findings evaluate the real-world prevalence and nature of adverse events among the population enrolled in our newly developed multicentre regional cohort. The establishment of this new database, given the absence of a national registry, will allow for closer monitoring of IBD patients undergoing conventional and advanced therapies and will increase awareness of the safety of these treatments.

Background Computer-aided detection (CADe) systems may increase adenoma detection rate (ADR) during colonoscopy. However, the variable results of CADe effects in different RCTs warrant investigation into factors influencing these results. Aims Investigate the different variables possibly affecting the impact of CADe-assisted colonoscopy and its effect on ADR. Methods We searched MEDLINE, EMBASE, and Scopus databases until July 2023 for RCTs reporting performance of CADe systems in the detection of colorectal neoplasia. The main outcome was pooled ADR. A random-effects meta-analysis was performed to obtain the pooled risk ratios (RR) with 95 % confidence intervals (CI)). To explore sources of heterogeneity, we conducted a meta-regression analysis using both univariable and multivariable mixed-effects models. Potential explanatory variables included factors influencing adenoma prevalence, such as patient gender, age, and colonoscopy indication. We also included both key (ADR), and minor (Withdrawal time) performance measures considered as quality indicators for colonoscopy. Results Twenty-three randomized controlled trials (RCTs) on 19,077 patients were include. ADR was higher in the CADe group (46 % [95 % CI 39-52]) than in the standard colonoscopy group (38 % [95 % CI 31-46]) with a risk ratio of 1.22 [95 % CI 1.14-1.29]); and a substantial level of heterogeneity (I2 = 67.69 %). In the univariable meta-regression analysis, patient age, ADR in control arms, and withdrawal time were the strongest predictors of CADe effect on ADR (P < .001). In multivariable meta-regression, ADR in control arms, and withdrawal time were simultaneous significant predictors of the proportion of the CADe effect on ADR. Conclusion The substantial level of heterogeneity found appeared to be associated with variability in colonoscopy quality performances across the studies, namely ADR in control arm, and withdrawal time.

Abstract Background Upadacitinib is a selective Jak-1 inhibitor approved for treating Inflammatory Bowel disease (IBD). Its efficacy and safety have been assessed in pivotal trials. Few real-world experiences of Upadacitinib in IBD patients have been published so far. We aimed to investigate the effectiveness and safety of Upadacitinib in a cohort of IBD patients in clinical practice. Methods This multicenter, observational study was performed among the Apulian Network for Inflammatory Bowel Disease (AN-IBD). All consecutive patients with IBD starting Upadacitinib from its introduction were included. Results We enrolled 68 patients with Ulcerative Colitis (UC) and 9 with Crohn’s Disease (CD. The mean age of the patients was 40.2 ± 14.2 (range 19 - 74) and 45.3 ± 11.8 (range 26 - 62) for UC and CD, respectively. Regarding gender, 51 patients were male (66.2%). The mean disease duration was 11.8 ± 8.4 (range 3 - 31) for UC patients and 11.4 ± 8.6 (range 2 - 26) for CD patients. As for disease extension, patients with UC were divided into three groups: pancolitis (n=31, 45.5%), distal colitis (n=33, 48.5%), and proctitis (n=4, 6%). In CD patients, 5 had ileitis (55.6%), 2 colitis (22%), 1 ileocolitis (11.2%) and 1 jejunoileitis (11.2%). The response and remission rates after 8 weeks were 39% and 52% in UC patients. The response and remission rates after 12 weeks were 66% and 16% in CD patients. The primary non-response rate was 9.5% and 16% in UC and CD, respectively. Regarding safety, two cases of herpes reactivation were observed (1 herpes zoster in a non-vaccinated patient, and 1 herpes simplex infection, both managed with antiviral therapy). One patient experienced mild anemia, rapidly corrected after switching to 15 mg/day. One non-responder underwent an urgent colectomy. Conclusion These preliminary data confirm the efficacy of upatacitinib in inducing responses in IBD patients (both UC and CD) with a very low rate of primary failure. No new safety issues were identified.

Aims Adequate bowel cleansing is a key-element for a quality colonoscopy and may affect the lesion detection rate. Differences in exposure to risk and protective factors could contribute to the gender difference in efficacy of bowel preparation. This post-hoc analysis of a randomised phase-IV clinical trial aims to explore gender differences in predictive factors associated with cleansing success (CS) and adenoma detection rate (ADR).

Aims The balance between prescription of colonoscopies and healthcare resources has been broken, leading to long waiting lists. Therefore, a triage system to define colonoscopy priority is needed. We recently demonstrated that Italian RAO criteria can effectively stratify CRC risk among patients undergoing colonoscopy. Aim of the present study was to derive and validate a predictive model for colorectal cancer (CRC) based on such criteria, aiming to risk-stratify patients undergoing colonoscopy outside organized screening programs.

Aims Acute pancreatitis represents the most frequently reported adverse event following ERCP. Identifying patients at higher risk may help to prevent the occurrence of this complication. Aim of this study was to investigate the incidence and factors associated to post-ERCP pancreatitis (PEP) and to provide a risk scoring system.

BACKGROUND AND AIMS:The quality of a colonoscopy is heavily reliant on the effectiveness of bowel cleansing. Various cleansing solutions are currently available, but their comparative efficacy remains uncertain. This systematic review and network meta-analysis aims to compare the performance of different bowel preparations for colonoscopy. METHODS:MEDLINE, Embase, Scopus, and the Cochrane Library were systematically searched for randomized controlled trials (RCTs) comparing the efficacy of different bowel preparations. The primary outcome was cleansing success (CS), and the secondary outcome was adenoma detection rate (ADR). RESULTS:On network meta-analysis for CS (22 RCTs, 7179 patients, 14 bowel preparations), 2 L PEG + simethicone (RR = 1.25 [95 %CI = 1.13-1.37]), 2 L PEG + lactulose (RR = 1.22 [95 %CI = 1.10-1.38]) and 1 L PEG + ascorbate (ASC) (RR = 1.03 [95 %CI = 1.01-1.06]) were significantly superior to 2 L PEG + ASC. Overall, 2 L PEG + lactulose resulted as the best product (SUCRA 0.94), followed by 2 L PEG + simethicone (SUCRA 0.93). On network meta-analysis for ADR (17 RCTs, 6639 patients, 11 bowel preparations), only 2 L PEG + simethicone (RR = 1.60 [95 %CI = 1.05-2.43]) resulted significantly superior to 2 L PEG + ASC. CONCLUSIONS:2 L PEG + simethicone, 2 L PEG + lactulose, and 1 L PEG + ASC seemed to provide high rates of CS, albeit only 2 L PEG + simethicone was associated with significantly higher ADR. Consequently, these products should be preferred for bowel preparation of colonoscopy. Further randomized studies with adequate sample sizes are needed for a more accurate comparison of these products on ADR.

BACKGROUND AND AIMS:One-fourth of colorectal neoplasia is missed at screening colonoscopy, representing the leading cause of interval colorectal cancer (I-CRC). This systematic review and meta-analysis summarizes the efficacy of computer-aided colonoscopy (CAC) compared to white-light colonoscopy (WLC) in reducing lesion miss rates. METHODS:Major databases were systematically searched through May 2024 for tandem-design RCTs comparing lesion miss rates in CAC-first followed by WLC vs WLC-first followed by CAC. The primary outcomes were adenoma miss rate (AMR) and polyp miss rate (PMR). The secondary outcomes were advanced AMR (aAMR) and sessile serrated lesion miss rate (SMR). RESULTS:Six RCTs (1718 patients) were included. AMR was significantly lower for CAC compared to WLC (RR = 0.46; 95 %CI [0.38-0.55]; P < 0.001). PMR was also lower for CAC compared to WLC (RR = 0.44; 95 %CI [0.33-0.60]; P < 0.001). No significant difference in aAMR (RR = 1.28; 95 %CI [0.34-4.83]; P = 0.71) and SMR (RR = 0.44; 95 %CI [0.15-1.28]; P = 0.13) were observed. Sensitivity analysis including only RCTs performed in CRC screening and surveillance setting confirmed lower AMR (RR = 0.48; 95 %CI [0.39-0.58]; P < 0.001) and PMR (RR = 0.50; 95 %CI [0.37-0.66]; P < 0.001), also showing significantly lower SMR (RR = 0.28; 95 %CI [0.11-0.70]; P = 0.007) for CAC compared to WLC. CONCLUSIONS:CAC results in significantly lower AMR and PMR compared to WLC overall, and significantly lower AMR, PMR and SMR in the screening/surveillance setting, potentially reducing the incidence of I-CRC.

Aims GI bleeding associated to endoscopic procedure is defined as clinical evidence of bleeding and a drop in hemoglobin of≥2g/dL on the day of the procedure (early bleeding) or up to 14 days after the procedure (delayed bleeding). GI bleeding is a common complication of endoscopic procedures, such as endoscopic mucosal resection (EMR) and endoscopic sub mucosal dissection (ESD). Endoscopic treatments encompass injection therapy (epinephrine, sclerosing agents), mechanical therapy (hemoclipsplacement),andthermaltherapy(monopolarandbipolarcoagulation,argonplasma coagulation, or heat probe). New endoscopic hemostasis modalities (topical hemostatic agents) are emerging as possible alternative endotherapies for primary hemostasis when bleeding is refractory or not amenable to standard endoscopic hemostasis therapies. We aim to establish a multicenter, observational registry to collect data related to the use of HaemoCer PLUS for the primary prevention of delayed bleeding linked to endoscopic resectional procedures of the lower GI tract. Primary aim: prevention of delayed bleeding after colonic EMR or ESD larger than 30 mm. Secondary aim: evaluation of possible adverse events (AEs) related to the application of the powder.

Aims The combination of fecal immunochemical test (FIT) followed by a colonoscopy has established itself as one of the preferred population-based screening strategies. Optimizing endoscopists' detection performances is essential for enhancing the effectiveness of Colorectal Cancer (CRC) screening programs in reducing incidence and mortality due to CRC. Despite extensive exploration of various techniques and technologies (ie mucosal exposure devices, chromoendoscopy), their impact on adenoma detection rate (ADR) has shown inconsistency across studies in this specific setting -FIT+population-. The aim of this meta-analysis is pooling data of all the randomized trials focused on this strategic subpopulation in order to address whether the implementation of a CADe system may increase the identification of CR neoplasia precursors within a structured colorectal cancer screening program based on FIT.

Aims Distinguishing gastrointestinal subepithelial lesions (GI-SELs) poses a clinical challenge because Endoscopic Ultrasound (EUS) is adept at detecting them but may fall short in providing effective differentiation. New methodologies have been introduced which provide further details and potential prognostic information. Elastography (EUS-E) allows to carry out a qualitative and semi-quantitative assessment of tissue stiffness, but for now only a few studies have examined its role in the diagnosis of SELs. Recent findings indicate that contrast agents enhance the diagnostic accuracy of EUS (CE-EUS) for SELs. The purpose of the study is to examine the performance of the EUS-E and CE-EUS in differentiating GI-SELs, and in particular gastrointestinal stromal tumors (GISTs).

Aims Radiofrequency ablation is a widely used technique for ablating flat dysplastic Barrett esophagus. Hybrid-APC (H-APC) is an emerging technique, which combines argon plasma coagulation with saline injection prior to ablation therapy to minimize damage to the muscular layers. Our goal was to conduct a systematic review of existing literature to assess the safety and efficacy of H-APC.

Aims Endoscopic ultrasonography (EUS) with fine needle biopsy (FNB) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. The aim of our study is to evaluate if during EUS-FNB only one needle pass inside the target lesions with MOSE evaluation can be satisfactory to obtain a correct diagnosis.

Aims GI bleeding associated to endoscopic procedure is defined as clinical evidence of bleeding and a drop in hemoglobin of ≥ 2g/dL on the day of the procedure (early bleeding) or up to 14 days after the procedure (delayed bleeding). GI bleeding is, nevertheless, a common complication of endoscopic procedures, such as endoscopic mucosal resection (EMR) and endoscopic sub mucosal dissection (ESD).We aim to establish a multicenter, observational registry to collect data related to the use of HaemoCer PLUS for the primary prevention of delayed bleeding linked to endoscopic resectional procedures of the lower GI tract.

Background and aims: A 1-L polyethylene glycol plus ascorbate (PEG-ASC) preparation has been recently developed to improve patients' experience in colonoscopy. This meta-analysis aimed to evaluate the effectiveness and safety of 1-L PEG-ASC compared with those of other bowel preparations for colonoscopy.Methods: MEDLINE, Embase, Scopus, and the Cochrane Library were systematically searched for randomized controlled trials comparing 1-L PEG-ASC with other bowel preparations published through July 2022. A random-effects model was applied for pooling the results; heterogeneity was expressed as I 2 .Results: Nine studies met the inclusion criteria and were included. The analysis showed significantly higher cleansing success (CS) (OR = 1.50; 95% CI = 1.25-1.81; p < 0.01, I 2 = 0%) and right-colon highquality cleansing (HQC) (OR = 1.67; 95% CI = 1.21-2.31; p < 0.01, I 2 = 43%) with 1-L PEG-ASC compared to the other preparations. The pooled estimate of the adenoma detection rate (ADR) did not significantly differ between the two groups either in the overall (OR = 1.02; 95% CI = 0.87-1.20; p = 0.79, I 2 = 0%) or split-dosing regimen subgroup analysis (OR = 0.99; 95% CI = 0.84-1.18; p = 0.94, I 2 = 0%). A significantly higher pooled estimate of the number of patients with adverse events (AEs) (OR = 1.51; 95% CI = 1.23-1.84; p < 0.01, I 2 = 0%) and incidence of AEs (IRR = 1.33; 95% CI = 1.11-1.58; p < 0.01, I 2 = 71%) was observed with 1-L PEG-ASC than with the other preparations. No serious AEs or deaths occurred.Conclusions: Compared to other preparations, 1-L PEG-ASC yielded higher overall CS, higher right-colon HQC rates, and similar ADR. The number of patients with AEs and incidence of the total AEs were significantly higher with 1-L PEG-ASC in the absence of serious AEs.& COPY; 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

BACKGROUND & AIMS:Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) is emerging as a safe and effective treatment for pancreatic neuroendocrine tumors. We aimed to compare EUS-RFA and surgical resection for the treatment of pancreatic insulinoma (PI). METHODS:Patients with sporadic PI who underwent EUS-RFA at 23 centers or surgical resection at 8 high-volume pancreatic surgery institutions between 2014 and 2022 were retrospectively identified and outcomes compared using a propensity-matching analysis. Primary outcome was safety. Secondary outcomes were clinical efficacy, hospital stay, and recurrence rate after EUS-RFA. RESULTS:Using propensity score matching, 89 patients were allocated in each group (1:1), and were evenly distributed in terms of age, sex, Charlson comorbidity index, American Society of Anesthesiologists score, body mass index, distance between lesion and main pancreatic duct, lesion site, size, and grade. Adverse event (AE) rate was 18.0% and 61.8% after EUS-RFA and surgery, respectively (P < .001). No severe AEs were observed in the EUS-RFA group compared with 15.7% after surgery (P < .0001). Clinical efficacy was 100% after surgery and 95.5% after EUS-RFA (P = .160). However, the mean duration of follow-up time was shorter in the EUS-RFA group (median, 23 months; interquartile range, 14-31 months vs 37 months; interquartile range, 17.5-67 months in the surgical group; P < .0001). Hospital stay was significantly longer in the surgical group (11.1 ± 9.7 vs 3.0 ± 2.5 days in the EUS-RFA group; P < .0001). Fifteen lesions (16.9%) recurred after EUS-RFA and underwent a successful repeat EUS-RFA (11 patients) or surgical resection (4 patients). CONCLUSION:EUS-RFA is safer than surgery and highly effective for the treatment of PI. If confirmed in a randomized study, EUS-RFA treatment can become first-line therapy for sporadic PI.

Aims Add-on devices, including Endocuff, Endocuff Vision, EndoRings and Wingcap, placed on the distal tip of the colonoscope have been manufactured to unfold the colonic mucosa and provide a thorough view of the lumen leading to higher detection of precancerous lesions. We performed a systematic review and metanalysis to evaluate the performance of these devices among individuals undergoing screening colonoscopy.

Aims Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) for the treatment of gastric outlet obstruction (GOO) has been performed so far, utilizing only one type of electrocautery lumen-apposing metal stents (EC-LAMS). We aimed to evaluate the safety, technical and clinical effectiveness of EUS-GE using a newly available EC-LAMS in patients with malignant and benign GOO [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13].