Radaelli, Franco

Abstract 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 and aims Artificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related to physician experience is not known. We performed a randomised trial with colonoscopists in their qualification period (AID-2) and compared these data with a previously published randomised trial in expert endoscopists (AID-1). Methods In this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (<2000 colonoscopies) performed screening/surveillance/diagnostic colonoscopies in consecutive 40–80 year-old subjects using high-definition colonoscopy with or without a real-time deep-learning computer-aided detection (CADe) (GI Genius, Medtronic). The primary outcome was ADR in both groups with histology of resected lesions as reference. In a post-hoc analysis, data from this randomised controlled trial (RCT) were compared with data from the previous AID-1 RCT involving six experienced endoscopists in an otherwise similar setting. Results In 660 patients (62.3±10 years; men/women: 330/330) with equal distribution of study parameters, overall ADR was higher in the CADe than in the control group (53.3% vs 44.5%; relative risk (RR): 1.22; 95% CI: 1.04 to 1.40; p<0.01 for non-inferiority and p=0.02 for superiority). Similar increases were seen in adenoma numbers per colonoscopy and in small and distal lesions. No differences were observed with regards to detection of non-neoplastic lesions. When pooling these data with those from the AID-1 study, use of CADe (RR 1.29; 95% CI: 1.16 to 1.42) and colonoscopy indication, but not the level of examiner experience (RR 1.02; 95% CI: 0.89 to 1.16) were associated with ADR differences in a multivariate analysis. Conclusions In less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experience appears to play a minor role as determining factor for ADR. Trial registration number NCT:04260321.