COLO-RECTAL EMR & DELAYED BLEEDING: PROSPECTIVE MULTICENTRE RANDOMIZED CONTROLLED SUPERIORITY TRIAL COMPARING PURASTAT® WITH CONVENTIONAL PRACTICE TO REDUCE THE RISK OF DELAYED BLEEDING AFTER COLO-RECTAL EMR IN HIGH RISK PATIENTS (COLOSTAT)

Research summary

Endoscopic excision has become the preferred way to remove benign polyps in the large bowel (colo-rectum), with significantly reduced risk and cost compared to surgical approach. Endoscopic Mucosal Resection (EMR) is the standard technique of endoscopic excision in the western endoscopy practice. Delayed bleeding (DB) is the most common complication following EMR, and it occurs in 3-12% of cases depending on various patient or polyp related risk factors. To date, there are no established guidelines to mitigate the risk of delayed bleeding DB following EMR, with various studies showing some inconsistent and sometimes conflicting results. PuraStat® is a CE marked liquid which is applied to a bleeding area that acts rapidly to form a gel coat which induces haemostasis and control bleeding. It is licensed for use in controlling exudative haemorrhage in vascular anastomoses and bleeding from vessels in solid organ and the GI tract. PuraStat® safety and efficacy during endoscopic resection has been studied in a prospective observational study by Subramanian et al and the team in Portsmouth. PuraStat® was found to be safe and effective in controlling intraprocedural bleeding, with effective haemostasis in 75% of cases. However, it has never been formally studied in a randomized controlled trial to determine it’s efficacy in reducing delayed bleeding rate following EMR. The aim of this study is to assess the efficacy of PuraStat® in reducing delayed bleeding rate following colorectal EMR in high risk patients compared to standard management. This is a randomized controlled superiority trial which will be conducted in multiple centers in the UK and Europe.

Principal Investigator

Dr James Edward East

Contact us

Email: ouh-tr.ctfresearch@nhs.net

IRAS number

281764