Promising new study evaluating safety and haemostatic efficacy in Endoscopic Retrograde Cholangiopancreatography (ERCP) for Post-Sphincterotomy bleeding

Endoscopic sphincterotomy (EST) is often performed before bile duct stone removal or metallic stent deployment under endoscopic retrograde cholangiopancreatography guidance. As an adverse complication, bleeding is commonly encountered. 

To stop the bleeding, various techniques may be applied (including epinephrine injection, balloon tamponade, hemoclips application and the novel self-expandable metal stent). Although endoscopic haemostasis can be achieved, there are concerns due to the delicate tissue in this area, the risks of post-ERCP pancreatitis and/or ulcer formation, and the associated high cost.  

In the new clinical study “Comparison of Endoscopic Hemostasis for Endoscopic Sphincterotomy Bleeding between a Novel Self-Assembling Peptide and Conventional Technique” (Clin Med. 2023 by Yuki Uba et al.),  the authors evaluated the safety and efficacy of PuraStat, haemostatic resorbable hydrogel, for the management of Post-Sphincterotomy bleedings vs conventional techniques. Procedure time and length of hospital stay were also compared. The study included N= 62 patients (26 treated with PuraStat vs 36 treated with conventional haemostatic techniques) with the following results: 

• Haemostatic efficacy: Comparable: 88.4% PuraStat group vs 72.2% the conventional treatment group 
  
  
• The procedure time was significantly shorter in PuraStat group compared with the conventional treatment group (mean 9.38 min vs mean 15.4 min)
  
  
• Adverse events were more frequently observed in the conventional treatment group (n = 12) than in the PuraStat group (n = 1)
  
  
• Mean hospital stay was significantly shorter in PuraStat group (7.8 days) compared with the conventional treatment group (13.8 days)i 

The results indicate that PuraStat application for EST bleeding may be safe and effective, and is comparable to the conventional techniques. 

The hospital stay duration after initial haemostasis was significantly shorter in the PuraStat group compared with the conventional group. This may be due to the higher rate of acute pancreatitis observed in the conventional group compared with the PuraStat group. However, this explanation should be evaluated by further prospective studies. 

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i Uba Y, Ogura T, Ueno S, Okuda A, Nishioka N, Miyano A, Yamamoto Y, Bessho K, Tomita M, Nakamura J, Hakoda A, Nishikawa H. Comparison of Endoscopic Hemostasis for Endoscopic Sphincterotomy Bleeding between a Novel Self-Assembling Peptide and Conventional Technique. J Clin Med. 2022 Dec 22;12(1):79. doi: 10.3390/jcm12010079. PMID: 36614880; PMCID: PMC9821301.