Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy
- Conditions
- Bleeding Hemorrhage
- Interventions
- Procedure: epinephrine solution injection
- Registration Number
- NCT04964869
- Lead Sponsor
- Wen-Hsin Huang
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epinephrine solution injection group epinephrine solution injection 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.
- Primary Outcome Measures
Name Time Method post EST bleeding rate 30 days delay post-sphincterotomy bleeding rate
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
China Medical University Hospital
🇨🇳Taichung, North Dist., Taiwan