Preventing delayed bleeding after endoscopic sphincterotomy with epinephrine injection
Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients with Transient Bleeding During ERCP
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung, North Dist.) |
| Trial ID | NCT04964869 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 years or older who experience transient bleeding after endoscopic sphincterotomy.
Not a fit: Patients with prior sphincterotomy, severe liver disease, or active gastrointestinal bleeding are unlikely to benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Taichung, North Dist.
- 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
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.