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

Not Applicable

Recruiting

• Conditions: Bleeding Hemorrhage

• Registration Number: NCT04964869
• Lead Sponsor: Wen-Hsin Huang

Brief 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.

Detailed Description

Backgroud:

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.

Study Rationale:

The hypotheses of the study is the prophylactic saline-epinephrine solution injection affects incidence of delayed post-EST bleeding.

Study Design:

A single blinded parallel group, multiple center, randomized controlled trial. The sample size is estimated 400 (200 in injection group and 200 in non-injection group), The primary outcome is the rate of delayed EST bleeding within 30 days of ERCP.

Study Objectives:

Primary objective: the rate of post-EST bleeding within 30 days of ERCP Secondary objectives: the rate of post-ERCP advese effect, the increasing procedure time because of hemostasis, the need for angiographic/endoscopic hemostasis times.

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-08
• Study Start: 2021-07-15
• Study First Posted: 2021-07-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
post EST bleeding rate	30 days	delay post-sphincterotomy bleeding rate

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, North Dist., Taiwan