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Published on: January 7, 2019
A peptide-first hemostatic strategy for oozing-type post-sphincterotomy bleeding during ERCP: a multicenter
Takeshi Ogura1, Tsukasa Ikeura2, Mamoru Takenaka3
1Pancreatobiliary Advanced Medical Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan; 2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan; Endoscopy Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan.
A self-assembling peptide (SAP) strategy was noninferior to balloon tamponade for immediate bleeding after endoscopic sphincterotomy (EST). The SAP approach demonstrated higher hemostasis rates and shorter procedure times in exploratory analyses.
Area of Science:
- Gastroenterology
- Endoscopic Procedures
- Hemostasis
Background:
- Immediate bleeding after endoscopic sphincterotomy (EST) is a frequent complication during ERCP.
- Optimal first-line hemostatic strategies for post-EST bleeding are not well-defined due to a lack of comparative trials.
Purpose of the Study:
- To evaluate the non-inferiority of a self-assembling peptide (SAP)-first strategy compared to conventional balloon tamponade for oozing-type immediate post-EST bleeding.
- To explore the superiority of the SAP-first strategy in a pre-specified analysis.
Main Methods:
- A multicenter, randomized controlled trial (PROTECT-EST) involving adults with persistent oozing-type bleeding after EST.
- Patients were randomized (1:1) to either SAP application or balloon tamponade as the initial hemostatic approach.
- The primary endpoint was successful initial hemostasis, defined as no active oozing for ≥3 minutes post-intervention.
Main Results:
- Self-assembling peptide (SAP) met the non-inferiority criterion against balloon tamponade.
- Exploratory analysis showed higher successful initial hemostasis with SAP (92.3%) versus balloon tamponade (76.9%).
- The SAP group experienced shorter procedure times and required fewer rescue devices (7.7% vs. 23.1%).
Conclusions:
- A self-assembling peptide (SAP)-first strategy is noninferior to balloon tamponade for immediate post-EST bleeding.
- The SAP strategy offers potential advantages including higher hemostasis rates and reduced procedure time.
- SAP may be a practical first-line option for managing post-ERCP bleeding, pending external validation.