Efficacy of PuraStat for the Prevention of Delayed Bleeding After Endoscopic Resection of Colorectal Lesions

1. BACKGROUND & RATIONALE

Endoscopic resection is used frequently for the management of benign and early neoplastic gastrointestinal (GI) lesions. Bleeding can occur during or after endoscopic mucosal resection and may impact patient's morbidity and mortality. Following colorectal endoscopic mucosal resection (EMR), the delayed bleeding rate may range between 5 and 9% [1, 2]. Several endoscopic hemostatic therapies based on coagulation, clipping or adrenaline may be used to prevent or treat post-polypectomy bleeding.

Adrenaline has a temporary effect, is associated with reduction of early post-polypectomy bleeding but does not reduce the risk of delayed bleeding [3]. The use of coagulation forceps may be associated with complications such as perforation [4] and necrosis [5], and its role on the prevention of delayed bleeding is not established yet [3]. Different hemoclips may be applied in this context. However, their use may be technically difficult in some colonic areas and may be more difficult to deploy and to remain in place for long periods in the left colon and rectum where the colonic wall is thicker [6]. Clips are effective in complete closure of mucosal defects in only 57% of cases [7] [6] and that has impact on the prevention of delayed bleeding. Most of the studies evaluating theses different strategies are performed in high-volume centers with high expertise on endoscopic therapy.

There is a need for a safe, effective and friendly to use preventive hemostatic therapy, that would be easier to deploy, irrespective of mucosal defect size, location and endoscopist's expertise.

PuraStat is a synthetic self-assembling aqueous peptide that ionises rapidly to form a network of nanofibers when it comes into contact with blood or ionic fluid. It is a safe, non-biogenic, biocompatible, resorbable peptide hydrogel with no infection transmission risk and is available in 1ml, 3ml and 5ml syringes. The syringe is connected to a dedicated endoscopy catheter that is placed through the working channel of the endoscope. It is CE marked and indicated for use for haemostasis in the following situations encountered, during surgery, when haemostasis by ligation or standard means is insufficient or impractical: bleeding from small blood vessels and oozing from capillaries of the parenchyma of solid organs, oozing from vascular anastomoses, bleeding from small blood vessels and oozing from capillaries of the GI tract following surgical procedures. PuraStat is also indicated for the reduction of delayed bleeding following gastrointestinal endoscopic submucosal dissection (ESD) procedures in the colon.