Preventing delayed bleeding after endoscopic sphincterotomy with epinephrine injection
Official title: Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients with Transient Bleeding During ERCP
Run by China Medical University Hospital · NCT04964869 · Data updated 2026-11-12
This study is testing if an injection of a saline-epinephrine solution can help prevent delayed bleeding in people who have had an endoscopic sphincterotomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung, North Dist.) |
| Status | Recruiting |
| Started | July 15, 2021 |
| Main results expected | December 2030 |
| Study ends | December 2030 |
| Registry record updated | October 24, 2024 |
| Trial ID | NCT04964869 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 20 years or older who experience transient bleeding after endoscopic sphincterotomy.
✕Probably not a fit
Patients with prior sphincterotomy, severe liver disease, or active gastrointestinal bleeding are unlikely to 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 efficacy of prophylactic injection of a saline-epinephrine solution to prevent delayed bleeding following endoscopic sphincterotomy (EST). It is a single-blinded, parallel group, multi-center, randomized controlled trial involving approximately 400 participants, divided into two groups: one receiving the injection and the other not. The primary outcome measured will be the incidence of delayed post-EST bleeding within 30 days after the procedure. Secondary outcomes include the rate of adverse effects and the need for additional hemostatic interventions.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of delayed bleeding complications in patients undergoing endoscopic sphincterotomy.
How similar studies have gone: While the use of epinephrine for managing post-sphincterotomy bleeding is common, the specific prophylactic approach being tested in this trial is novel and has not been extensively studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 20 years or older. * Ability to give informed consent. * An naive major papilla. * Transient bleeding after endoscopic sphincterotomy * Bleeding less than 30 secs when end of procedure Exclusion Criteria: * Prior endoscopic sphincterotomy. * Thrombocytopenia (platelets \<50,000/mm3). * Liver cirrhosis (Child A-C) * CKD stage 4-5 and dialysis. * Allergy to epinephrine * Prolonged PT/APTT (INR\>1.5) * Had exposure any antithrombotic or antiplatelet agent in recent 7 days and/or will take those agents in one month after EST * Ampulla Vater tumor * Active GI bleeding * Pregnancy * Limited visibility when immediate bleeding after sphincterotomy * Still bleeding after 30 secs when end of procedure * Recurrent bleeding during ERCP
Where it's running
-
China Medical University Hospital
Taichung, North Dist., Taiwan Recruiting
Study contacts
- Principal investigator: Wen-Hsin Huang, MD — China Medical University Hospital
- Study coordinator: Shih-Chieh Chuang, MD
- Email: D18114@mail.cmuh.org.tw
- Phone: +886-975680839
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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.