Preventing bleeding after sphincterotomy during ERCP
Prevention of Post-sphincterotomy Bleeding by Endoscopic Tranexamic Acid and Sucralfate Administration: A Randomized Controlled Trial
NA · National Cheng-Kung University Hospital · NCT06107504
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | National Cheng-Kung University Hospital (other) |
| Locations | 1 site (Tainan, Other (Non U.s.)) |
| Trial ID | NCT06107504 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are not scheduled for sphincterotomy or have allergies to sucralfate may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tainan, Other (Non U.s.)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-ERCP Bleeding