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 range20 Years

SexALL

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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

What they're measuring

post EST bleeding rate

Timeframe: 30 days

Trial details

NCT IDNCT04964869

SponsorWen-Hsin Huang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12

Contact for this trial

Shih-Chieh Chuang, MD

+886-975680839 D18114@mail.cmuh.org.tw

View on ClinicalTrials.gov More Bleeding Hemorrhage trials