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

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 Overview

• Status: Recruiting
• Conditions: Bleeding Hemorrhage
• Intervention / Treatment: Procedure: epinephrine solution injection

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shih-Chieh Chuang, MD; Phone Number: +886-975680839; Email: D18114@mail.cmuh.org.tw
• Study Contact Backup: Name: Wen-Hsin Huang, MD; Phone Number: 2233 +886-4-2205-2121; Email: u97766.huang@msa.hinet.net

Study Locations

• Taiwan
  • North Dist.
    • Taichung, North Dist., Taiwan, 404332
      • Recruiting
      • China Medical University Hospital
      • Contact: Shih-Chieh Chuang, MD; Phone Number: +886-975680839; Email: D18114@mail.cmuh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: epinephrine solution injection; epinephrine solution injection at least 1 ml to the post- sphincterotomy wound
No Intervention: non-injection group; In non injection group, the saline epinephrine solution is not given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post EST bleeding rate	delay post-sphincterotomy bleeding rate	30 days

Collaborators and Investigators

• Sponsor: Wen-Hsin Huang
• Investigators: Principal Investigator: Wen-Hsin Huang, MD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Anticipated): December 1, 2030
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: sphincterotomy; epinephrine solution
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine
• Other Study ID Numbers: CMUH110-REC2-055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No