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Prevention of Post-sphincterotomy Bleeding

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date changed from estimate of Dec 31, 2024 to Feb 28, 2025
    • Study completion date: Dec 31, 2024 to Jul 31, 2025
    v6
  2. Secondary endpoints revised (5)v5
  3. Enrollment target: 60 to 120
    • Secondary endpoints: 4 to 5
    • Study description revised
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 1, 2023 to Jan 1, 2024
    v3
  5. Study description revisedv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06107504
Lead Sponsor National Cheng-Kung University Hospital
Conditions
(from sponsor)		 Post-ERCP Bleeding
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov