Clinical trial Recruiting at 1 site Interventional Ages 18 to 95

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 typeInterventional
Ages18 Years to 95 Years
SexAll
Enrollment120 (estimated)
SponsorNational Cheng-Kung University Hospital
Academic / other
Locations1 site (Tainan, Other (Non U.s.))
StatusRecruiting
StartedJanuary 1, 2024
Main results expectedFebruary 28, 2025
Study endsJuly 31, 2025
Registry record updatedMay 25, 2025
Trial IDNCT06107504 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.