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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bleeding Hemorrhage

Intervention / Treatment
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* Procedure: epinephrine solution injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epinephrine solution injection group<br>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<br>* epinephrine solution injection at least 1 ml to the post- sphincterotomy wound<br>|
| No Intervention: non-injection group<br>In non injection group, the saline epinephrine solution is not given | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sphincterotomy, epinephrine solution