Franco Radaelli

In fecal immunochemical test (FIT)-based colorectal cancer (CRC) screening, colonoscopy after a positive FIT often identifies no CRC or advanced neoplasia, leaving management poorly standardized. We mapped evidence on definitions, extracolonic evaluation, colonoscopy quality, residual CRC risk, and screening re-entry after a positive FIT and nonexplanatory colonoscopy. This registered scoping review followed PRISMA-ScR guidance. PubMed/MEDLINE, Scopus, and Web of Science were searched until April 2026, along with reference-list screening and targeted searching of official screening program/policy documents. Sources were charted by one reviewer; included sources, uncertain eligibility decisions, and key findings underwent second-reviewer verification. We included 10 studies on definitions, 11 empirical studies plus three contextual evidence syntheses on evaluation beyond the colon, 11 core empirical studies on colonoscopy quality/residual CRC risk, and nine empirical studies on management and screening re-entry, supplemented by policy mapping. Definitions varied substantially, supporting “nonexplanatory colonoscopy” as a pragmatic umbrella term. Routine upper gastrointestinal or small-bowel evaluation was not supported in otherwise asymptomatic individuals. Reassurance was quality dependent; residual CRC risk was low in the short term, but not zero. Screening re-entry pathways varied and were not evidence based. Management should first be to establish whether the index colonoscopy is reliable enough to justify reassurance. After a trusted negative examination, the evidence does not support routine upper gastrointestinal or small-bowel evaluation, or routine early repeat colonoscopy in otherwise asymptomatic individuals. Residual CRC risk remains low but not zero, and optimal screening re-entry remains uncertain.

Adequate bowel preparation is essential for high-quality colonoscopy but remains challenging in hospitalized patients, and comparative data on preparation volume are limited. To compare the efficacy, tolerability, and safety of very low-volume (1-liter [1L]), low-volume (2-liter [2L]), and high-volume (4-liter [4L]) polyethylene glycol (PEG) regimens for inpatient colonoscopy preparation. Multicenter, randomized controlled, endoscopist-blinded trial. (EudraCT: 2019-002799-15; ClinicalTrials.gov: NCT04708366). Community and academic hospitals in Italy. Hospitalized adults undergoing elective colonoscopy. Patients were randomly assigned (1:1:1) to split-dose 1L PEG-ascorbate, 2L PEG-ascorbate, or 4L PEG. Primary end point was adequate bowel cleansing (Boston Bowel Preparation Scale [BBPS] score ≥6 with all segments ≥2). Secondary end points included high-quality cleansing (BBPS score, 8 to 9), high-quality right-colon cleansing (BBPS score, 3), and willingness to repeat. Among 665 randomly assigned patients (1L, n = 228; 2L, n = 218; 4L, n = 219), adequate overall cleansing occurred in 82.0%, 78.0%, and 78.5% (absolute difference between the 1L and 2L groups [Δ1L-2L], 4.0 percentage points [95% CI, -3.4 to 11.4 percentage points]; absolute difference between the 1L and 4L groups [Δ1L-4L], 3.5 percentage points [CI, -3.9 to 10.9 percentage points]). High-quality overall cleansing occurred in 46.9%, 35.3%, and 37.4% (Δ1L-2L, 11.6 percentage points [CI, 2.5 to 20.5 percentage points]; Δ1L-4L, 9.5 percentage points [CI, 0.3 to 18.5 percentage points]). High-quality right-colon cleansing occurred in 40.6%, 29.5%, and 31.6% (Δ1L-2L, 11.2 percentage points [CI, 2.1 to 20.0 percentage points]; Δ1L-4L, 9.0 percentage points [CI, 0.0 to 17.9 percentage points]). Tolerability was good across regimens, with the highest willingness to repeat in the 1L group (84.2%), despite more frequent vomiting and thirst. Patients requiring urgent colonoscopy for active gastrointestinal bleeding and those with severe/unstable comorbid conditions were excluded. In hospitalized adults undergoing elective colonoscopy, 1L PEG-ascorbate yielded higher rates of high-quality cleansing, including right colon, than 2L PEG-ascorbate and 4L PEG, with similar rates of adequate cleansing and high willingness to repeat. Norgine Srl.

Colonoscopy efficacy for colorectal cancer (CRC) prevention is limited by inappropriate or over- prescription. Colonoscopy appropriateness prioritization (CAP) criteria have recently been proposed, but their role in CRC risk stratification remains unclear. The study objective was to derive and validate a predictive model for CRC taking account of CAP criteria, and to assess CRC occurrence in the light of appropriateness of colonoscopies. In a prospective observational study across 19 Italian centers, including adults undergoing colonoscopy outside CRC screening programs, three cohorts were analyzed for derivation, temporal validation, and geographic validation of the model. CRC risk was estimated by multivariable logistic regression. Model performance was assessed using the area under the receiver operating characteristic (AUROC), and two risk groups were defined: low-risk (<5%) and high-risk (≥5%). Number-needed-to-scope (NNS) was calculated. The derivation and temporal and geographic validation, cohorts included 2059, 1321, and 1924 patients, respectively, with CRC prevalence 3.6%, 3.9%, and 3%, respectively. CRC was more frequent in appropriate versus inappropriate colonoscopies. The PROMOTE model included: ages 50–59 (odds ratio [OR] 1.89, 95% confidence interval [CI] 0.64–5.59), 60–69 (OR 3.87, 95%CI 1.40–10.71), and ≥70 (OR 5.35, 95%CI 2.04–14.06), versus <50; no colonoscopy in previous 10 years (OR 2.92, 95%CI 1.62–5.25); according to CAP criteria, deferrable (OR 3.44, 95%CI 1.42–8.34) and urgent (OR 16.12, 95%CI 7.15–36.36) versus nonurgent. Discrimination was good (AUROC 0.84, 95%CI 0.79–0.89). NNS was 8–9 in the high-risk group and 67–71 in the low-risk group across validation cohorts. We developed and validated the PROMOTE model, a simple tool to estimate CRC risk before colonoscopy, to support appropriate referral, optimize prioritization, and improve resource use.

Cholangioscopy has improved the management of complex biliary diseases; however, digital single‐operator cholangioscopy (DSOC) still faces key limitations, especially in treating intrahepatic disease like hepatolithiasis and strictures, which often require surgery with significant mortality risk. This video case report illustrates the successful endoscopic treatment of an elderly woman with multiple left intrahepatic duct stones and a benign stricture. A next‐generation 11‐Fr high‐definition cholangioscope (VedVision) was employed, offering enhanced imaging, improved maneuverability, and a dual‐channel system enabling simultaneous guidewire and lithotripsy probe use. Electrohydraulic lithotripsy achieved complete stone clearance. A balloon‐expandable biodegradable stent (UNITY‐B), composed of magnesium alloy with polymer coating, was placed across the stricture to reshape it. Subsequent cholangioscopy confirmed correct positioning. This approach highlights a promising, non‐surgical strategy for managing benign intrahepatic biliary disease. The biodegradable stent eliminates the need for removal, reducing the need for further interventions. However, long‐term data and larger studies are necessary to confirm its safety and efficacy.

Both computer-aided detection (CADe) systems and mucosal exposure devices can enhance adenoma detection during colonoscopy. This research investigates whether combining a CADe system with a balloon-based mucosal exposure device increases the identification of individuals with high risk colonoscopy findings within a fecal immunochemical test (FIT)-based organized screening program. We conducted a multicenter, open-label, parallel-arm randomized controlled trial. FIT-positive subjects were randomized 1:1 to either CADe-assisted colonoscopy with a balloon-based mucosal exposure device (CADe+balloon arm) or CADe-assisted colonoscopy alone (CADe arm). Randomization was performed using a computer-generated block sequence, with age and sex stratified. Participants, but not endoscopists, were masked to the random assignment. The primary end point was the rate of individuals with high risk colonoscopy findings according to ESGE criteria (≥5 low risk adenomas or ≥1 advanced adenoma or ≥1 advanced serrated lesion). The key secondary end point was the adenoma detection rate (ADR). 644 subjects (51.5% women) were randomized in three centers. High risk findings were observed in 19.3% (95%CI 15.0% to 23.5%) of the CADe+balloon arm and 23.1% (95%CI 18.4% to 27.8%) of the CADe arm (P = 0.24). The ADR was 55.4% (95%CI 50.1% to 60.8%) versus 59.1% (95%CI 53.8% to 64.8%) in the CADe+balloon and CADe arms, respectively (P = 0.32). No adverse events were reported. In a FIT-based screening program, adding a balloon-based mucosal exposure device to CADe-assisted colonoscopy did not enhance the detection of subjects with high risk features or of neoplastic lesions. A CADe-related ceiling effect may have limited the benefit of the additional device.

Gastrointestinal (GI) endoscopy has evolved from a diagnostic tool into a therapeutic modality, leading to a higher incidence of bleeding complications during and after procedures. To address this issue, various hemostatic agents have been developed, including injectable, mechanical, thermal, and topical products. Topical hemostatic agents, available in powder or gel forms, can be used as standalone treatments or as adjuncts to traditional hemostatic therapies to control or prevent bleeding.This Technical and Technology Review examines the commercially available topical hemostatic agents used in endoscopy, specifically Purastat, TC-325 Hemospray, EndoClot PHS, Nexpowder, Ankaferd Blood Stopper, and CG GEL. A systematic literature review was conducted up to January 2025, focusing on randomized controlled trials (RCTs), meta-analyses, and observational studies. Each product was assessed for its composition, mechanism of action, regulatory status, mode of use, efficacy, safety, and financial considerations.Purastat showed 94% efficacy in acute GI bleeding, reducing delayed bleeding to 4.3% in endoscopic submucosal dissection (ESD) and endoscopic mucosal resection cases, with significantly lower thermal device usage. TC-325 Hemospray achieved 85%–98.5% primary hemostasis in upper and lower GI bleeding, with pooled hemostasis rates of 93.1% and rebleeding rates of 8.9%. It was also effective in malignancy-related bleeding, with hemostasis success up to 100%. EndoClot PHS demonstrated 76%–100% hemostasis efficacy, comparable with TC-325, with rebleeding rates of 24%–25%. It showed prophylactic potential post-ESD, with rebleeding rates of 7.3%–9.1%. Nexpowder achieved 94% hemostasis in refractory upper GI bleeds and reduced rebleeding in lower GI bleeds to 5.5% at 28 days. Ankaferd Blood Stopper demonstrated 73%–100% hemostasis across various GI bleeding sources, including peptic ulcers and malignancies, though further data on rebleeding are needed.Topical hemostatic agents offer effective options for managing GI bleeding. Products like Purastat, TC-325 Hemospray, EndoClot PHS, Nexpowder, Ankaferd Blood Stopper, and CG GEL have shown promising results in achieving hemostasis; however, further RCTs and cost-effectiveness analyses are needed to better establish their roles in endoscopic practice.

Background Lower gastrointestinal bleeding (LGIB) is a common condition linked to increased morbidity, healthcare costs, and mortality. Currently, no prospectively validated prognostic model exists to predict mortality in patients with LGIB. Our aim was to develop and validate a risk score that could accurately predict in-hospital mortality of patients admitted for LGIB. Methods Patient data from a nationwide cohort study in 15 centers in Italy (2019–2020) were used to derive the risk score, the Acute Lower gastrointestinal Bleeding and In-hospital mortality (ALIBI) score; the model was then externally validated in a cohort of consecutive patients hospitalized for LGIB in 12 centers from six countries (Italy, Spain, France, Greece, Iran, and Brazil) from 2022 to 2024. The main outcome was in-hospital mortality; we also reported rebleeding rates and the in-hospital mortality rate stratified by risk score and timing of colonoscopy. Results Among 1198 patients in the derivation cohort, 105 (8.8%) re-bled and 41 (3.4%) died. Age, Charlson Co-morbidity Index, in-hospital onset, hemodynamic instability, and creatinine level were independent predictors of in-hospital mortality. The model demonstrated excellent discrimination (area under the receiver operating curve [AUROC] 0.81, 95%CI 0.75–0.87) and calibration. In the validation cohort (n = 752 patients), the model's good discrimination (AUROC 0.79, 95%CI 0.72–0.86) and calibration were confirmed. Patients were categorized as low (0–4 points; 1% mortality), intermediate (5–9 points; 4.6% mortality), or high risk (10–13 points; 19.1% mortality). Conclusion A new validated score effectively predicts in-hospital mortality in patients with LGIB, aiding in their risk stratification and management.