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

Recruiting now · Not applicable

Conditions studied: Bleeding Hemorrhage

In brief

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.

Key facts

Study ID

NCT04964869

Run by

Wen-Hsin Huang

People needed

400

Starts

2021-07-15

Expected to finish

2030-12-01

Last updated by the study team

2024-10-24

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• China Medical University Hospital — Taichung, North Dist., Taiwan (enrolling)

Full record on ClinicalTrials.gov

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