RecruitingNot ApplicableNCT04964869

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

Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients with Transient Bleeding During ERCP


Sponsor

Wen-Hsin Huang

Enrollment

400 participants

Start Date

Jul 15, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Inclusion Criteria5

  • 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 Criteria13

  • 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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Interventions

PROCEDUREepinephrine solution injection

epinephrine solution injection at least 1 ml to the post- sphincterotomy wound


Locations(1)

China Medical University Hospital

Taichung, North Dist., Taiwan

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NCT04964869