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Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy

RecruitingNAAges 20 Years - anyAllWen-Hsin Huang
NCT04964869 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • epinephrine solution injection
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Where

1 site
China Medical University Hospital
Taichung, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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