Prevention of Post-sphincterotomy Bleeding

NCT06107504 NA RECRUITING

Background and Aim: Endoscopic retrograde cholangiopancreatography (ERCP) and sphincterotomy (EST) are standard treatments for choledocholithiasis. However, 10% of post-EST bleeding was reported. Currently, there are no effective methods or medications for the prevention of post-EST bleeding. This study aimed to investigate whether the local administration of TXA and sucralfate can reduce the post-EST bleeding event. Methods: This is a randomized clinical trial. Patients with choledocholithiasis scheduled for ERCP with EST at National Cheng Kung University Hospital and Siriraj Hospital were enrolled. The study will recruit 120 patients. After randomization, 60 patients will be classified into the intervention group and 60 into the control group. The participants will receive standard ERCP and EST for common bile duct stone removal. If immediate polypectomy bleeding occurs, the investigators will apply standard endoscopic therapy by either local injection of diluted epinephrine or heater probe coagulation. After then, the investigators will spray 2g of sucralfate powder and 1g of tranexamic acid through duodenoscopy precisely on the post-EST wound in the intervention group. All enrolled patients will be monitored for delayed bleeding for 14 days after the ERCP.

Details

Lead sponsor	National Cheng-Kung University Hospital
Phase	NA
Status	RECRUITING
Enrolment	120
Start date	Mon Jan 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Post-ERCP Bleeding

Interventions

• Sucralfate

Countries

Taiwan