Prophylactic self-assembling haemostatic gel after colorectal endoscopic submucosal dissection in high bleeding-risk patients: the PURASTOP randomised controlled trial

Aims Delayed bleeding is a major complication after colorectal endoscopic submucosal dissection (ESD), especially in patients receiving antithrombotic therapy, at high risk of delayed bleeding according to DEBE score. The efficacy of prophylactic haemostatic gel application in this high-risk setting remains uncertain. Methods It was a prospective multicentre randomised controlled trial. Adult patients with a single colorectal neoplastic lesion≥3 cm undergoing ESD and receiving therapeutic anticoagulant and/or antiplatelet therapy were randomised (1:1) to prophylactic gel application or no gel. Randomization was done at the end of the ESD procedure after prophylactic hemostasis. The primary endpoint was the delayed clinical significant bleeding within 30 days. Analyses were performed on an intention-to-treat basis. Results A total of 296 patients were randomized between February 2022 and January 2025 (146 in the control arm, 150 in the PuraStat arm). Baseline characteristics were comparable between groups, with a mean age of 75.8 years and 80.4% of patients on anticoagulant therapy. All lesions were resected en bloc by ESD. The overall delayed bleeding rate was 24.1% (69/286 evaluable patients), with 22.5% in the control group and 25.7% in the PuraStat group. After accounting for the worst-case bias related to missing data, the rates were 21.9% and 28.7%, respectively. Adjusted analysis for stratification factors (DEBE score, location, type of treatment) did not show a significant difference between groups (p=0.1686), whereas treatment type (antiplatelet (except aspirin