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.

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.

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.

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