Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: epinephrine solution injection.
- Who it may be relevant to
- Registry conditions: Bleeding Hemorrhage. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients with Transient Bleeding During ERCP
Overview
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.
Interventions
- Procedure epinephrine solution injection
epinephrine solution injection at least 1 ml to the post- sphincterotomy wound
Primary outcome measures
- post EST bleeding rate [Time frame: 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Taiwan · 1 center
- China Medical University Hospital — Taichung
Identifiers
NCT: NCT04964869 · CMUH110-REC2-055