Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients with Transient Bleeding During ERCP
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- post EST bleeding rate
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: epinephrine solution injection (Procedure)
non-injection group
In non injection group, the saline epinephrine solution is not given
Outcomes
Primary Outcomes
post EST bleeding rate
Time Frame: 30 days
delay post-sphincterotomy bleeding rate
Secondary Outcomes
No secondary outcomes reported
Investigators
Wen-Hsin Huang
Gastroenterology and Hepatology Deputy Director
China Medical University Hospital