Pilot Study Evaluating PuraStat’s Efficacy in Preventing and Controlling Bleeding During Walled-Off Pancreatic Necrosis Drainage: A Case Series

Bleeding, both intraprocedural and delayed, is one of the most frequent adverse events in the case of endoscopic ultrasound (EUS) guided drainage of walled-off pancreatic necrosis (WOPN) and of direct endoscopic necrosectomy (DEN). When bleeding occurs, its management can pose challenges, mainly because of the difficulties in obtaining effective haemostasis and because of the “extraluminal”/peritoneal location.

In the new clinical study by Binda C. et al., published in Medicina (2023), the authors evaluated PuraStat’s safety & efficacy in preventing and controlling bleeding of WOPN drainage using lumen-apposing metal stents (LAMS).

This multicentre retrospective study involved N=10 patients that underwent endoscopic ultrasound (EUS) guided drainage of the walled-off pancreatic necrosis from either the stomach or duodenum with the deployment of lumen-apposing metal stents, followed by direct endoscopic necrosectomy (DEN).

Technical success of PuraStat was achieved in 100% of patients.

PuraStat was applied:

• to manage active bleeding in 3/10 patients: in 2 patients to successfully stop oozing bleeding, in 1 patient as a bridge to embolization in a case of spurting bleeding⁽¹⁾.
  
  
• for post-DEN bleeding prevention in 7/10 patients: only in 1 patient rebleeding was experienced.

No PuraStat-related adverse events were reported.

The authors concluded that PuraStat is effective in achieving haemostasis for oozing-bleeding, but also can play a role in the management of spurting bleeding to temporarily control the blood loss as a haemostatic bridge agent to subsequent radiological or surgical treatments. Moreover, PuraStat can be easily and safely applied for the prevention of delayed post-DEN bleeding and might promote cavity resurfacing, enhancing walled-off pancreatic necrosis resolution.

Further prospective studies are needed to confirm these hypotheses.

Click here to read the full study.

For application within GI, PuraStat is indicated for⁽²⁾:
- Bleeding from small blood vessels and oozing from capillaries of the GI tract following surgical procedures and the surrounding tissues.
- PuraStat is also indicated for the reduction of delayed bleeding following gastrointestinal endoscopic submucosal dissection (ESD) procedures in the colon. 

(1) - The publication: Binda, C., Fugazza, A., Fabbri, S., Coluccio, C., Repici, A., Tarantino, I., Anderloni, A., & Fabbri, C. (2023). The Use of PuraStat® in the Management of Walled-Off Pancreatic Necrosis Drained Using Lumen-Apposing Metal Stents: A Case Series. Medicina (Kaunas, Lithuania), 59(4), 750. https://doi.org/10.3390/medicina59040750, also describes procedures and contains data which are currently not within the indication of PuraStat. It concerns the use of PuraStat in the management of spurting-type bleeding which is not covered by the current indication of PuraStat. 
(2) - PuraStat IFU-007 Rev-2