NCT04964869

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Wen-Hsin Huang · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bleeding Hemorrhage

Interventions

Type	Name	Description
PROCEDURE	epinephrine solution injection	epinephrine solution injection at least 1 ml to the post- sphincterotomy wound

Timeline

• Start date: 2021-07-15
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2021-07-16
• Last updated: 2024-10-24

Locations

1 site across 1 country: Taiwan