Preventing bleeding after sphincterotomy during ERCP
Official title: Prevention of Post-sphincterotomy Bleeding by Endoscopic Tranexamic Acid and Sucralfate Administration: A Randomized Controlled Trial
Run by National Cheng-Kung University Hospital · NCT06107504 · Data updated 2026-11-12
This study is testing if giving a medication called tranexamic acid and sucralfate can help prevent bleeding after a procedure to remove stones from the bile duct in patients undergoing ERCP.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 95 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Locations | 1 site (Tainan, Other (Non U.s.)) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | February 28, 2025 |
| Study ends | July 31, 2025 |
| Registry record updated | May 25, 2025 |
| Trial ID | NCT06107504 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are scheduled for ERCP and sphincterotomy for common bile duct stone extraction.
✕Probably not a fit
Patients who are not scheduled for sphincterotomy or have allergies to sucralfate may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of local administration of tranexamic acid (TXA) and sucralfate in reducing post-sphincterotomy bleeding in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) for common bile duct stone removal. A total of 120 patients will be randomly assigned to either an intervention group receiving the treatment or a control group. The study aims to address the significant complication of delayed bleeding after sphincterotomy, which can lead to increased mortality and prolonged hospital stays. The trial is being conducted at National Cheng Kung University Hospital and Siriraj Hospital.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of post-sphincterotomy bleeding, improving patient outcomes and reducing hospital stays.
How similar studies have gone: While there is limited data on the specific combination of TXA and sucralfate for this purpose, the use of TXA in other bleeding scenarios has shown promise, indicating potential for success in this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥ 18 years who accept ERCP and sphincterotomy for common bile duct (CBD) stone extraction Exclusion Criteria: * Paitnets with no schedules for sphincterotomy * Paitnets with unsuccessful CBD cannulation * Patients with allergy to sucralfate
Where it's running
-
National Cheng-Kung University Hospital
Tainan, Other (Non U.s.), Taiwan Recruiting
Study contacts
- Study coordinator: Hsueh-Chien Chiang, M.D.
- Email: scion456scion@gmail.com
- Phone: 2353535
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.