Controlled Trial to Evaluate the Efficacy of PuraStat in Reducing  Delayed Bleeding (in high-risk patients) After Colonic Endoscopic Submucosal Dissection Has Started in France.

The new clinical trial “Multicentre Randomised Controlled Trial (RCT) to assess the efficacy of a haemostatic agent in reducing delayed bleeding after endoscopic submucosal colorectal dissection” has started in France.

The occurrence of delayed bleeding (DB) following endoscopic submucosal dissection (ESD) is a frequent complication in clinical practice. Various preventive treatments such as the prophylactic use of clips are utilised but may be technically challenging and only partially effective.

Previous studies have shown that PuraStat, a ready-to-use and easily applicable solution, may decrease the rate of delayed bleeding by promoting wound healing. Currently PuraStat is only indicated for delayed bleed reduction following colonic ESD.

Reducing the occurrence of a delayed haemorrhage in high-risk patients could lead to further advantages, such as avoiding the need of additional endoscopic procedures and hospitalization, decreasing the need of transfusions and the cost of management (hospital stays).

The study promoted by the Société Française d'Endoscopie Digestive (SFED) is planned for 18 months. 

The aim of this national RCT study is to evaluate PuraStat’s efficacy in preventing DB in a homogenous high-risk group of delayed bleedings compared to routine care (the inclusion will be limited to high-risk patients with large colorectal lesions >30mm and on anti-coagulant/anti-aggregating treatment). For more information about the clinical trial click here. 

Further clinical trials evaluating PuraStat’s preventive effect in a homogeneous high-risk group of patients are welcomed.