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

Overview

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.

Full Title of Study: “Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients With Transient Bleeding During ERCP”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 2030

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Epinephrine solution injection group
    • In injected group, The saline epinephrine solution (1mg in 10ml N/S) is injected to 2 sites of cutted papilla (1 o’clock and 11 o’clock) by injected needle, at least 0.5ml per injected site, and must be protruded from submucosal layer.
  • No Intervention: non-injection group
    • In non injection group, the saline epinephrine solution is not given

Clinical Trial Outcome Measures

Primary Measures

  • post EST bleeding rate
    • Time Frame: 30 days
    • delay post-sphincterotomy bleeding rate

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wen-Hsin Huang
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Wen-Hsin Huang, Gastroenterology and Hepatology Deputy Director – China Medical University Hospital
  • Overall Official(s)
    • Wen-Hsin Huang, MD, Principal Investigator, China Medical University Hospital
  • Overall Contact(s)
    • Shih-Chieh Chuang, MD, +886-975680839, D18114@mail.cmuh.org.tw

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.