Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT04964869

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

Led by Wen-Hsin Huang · Updated on 2024-10-24

400

Participants Needed

1

Research Sites

489 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 years or older.
  • Ability to give informed consent.
  • A naive major papilla.
  • Transient bleeding after endoscopic sphincterotomy.
  • Bleeding lasting less than 30 seconds at the end of the procedure.
Not Eligible

You will not qualify if you...

  • Prior endoscopic sphincterotomy.
  • Thrombocytopenia (platelets less than 50,000/mm3).
  • Liver cirrhosis (Child A-C).
  • Chronic kidney disease stage 4-5 and dialysis.
  • Allergy to epinephrine.
  • Prolonged PT/APTT (INR greater than 1.5).
  • Recent use or planned use of antithrombotic or antiplatelet agents within one month after EST.
  • Ampulla Vater tumor.
  • Active gastrointestinal bleeding.
  • Pregnancy.
  • Limited visibility due to immediate bleeding after sphincterotomy.
  • Bleeding lasting more than 30 seconds at the end of the procedure.
  • Recurrent bleeding during ERCP.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

China Medical University Hospital

Taichung, North Dist., Taiwan, 404332

Actively Recruiting

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Research Team

S

Shih-Chieh Chuang, MD

CONTACT

W

Wen-Hsin Huang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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