Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy (NCT04964869) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy
Taiwan400 participantsStarted 2021-07-15
Plain-language summary
Bleeding is the most frequently reported serious complication of endoscopic sphincterotomy, and severe bleeding has occurred in about 1% to 2% of patients. Endoscopic injection of epinephrine is the most commonly used, effective, and least expensive method for the management of post- sphincterotomy bleeding. However, the efficacy of prophylactic saline-epinephrine solution injection to prevent delayed EST bleeding when transient bleeding During ERCP has not been established.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.