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

Bleeding Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04964869
• Other study ID #: CMUH110-REC2-055
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: December 2030

Study information

• Verified date: May 2023
• Source: China Medical University Hospital
• Contact: Shih-Chieh Chuang, MD
• Phone: +886-975680839
• Email: D18114[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Hemorrhage
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung	North Dist.

Sponsors (1)

Lead Sponsor	Collaborator
Wen-Hsin Huang

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post EST bleeding rate	delay post-sphincterotomy bleeding rate	30 days