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

Wen-Hsin Huang

Status: Enrolling

Conditions: Bleeding Hemorrhage

Treatments: Procedure: epinephrine solution injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04964869

CMUH110-REC2-055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups

Epinephrine solution injection group

Experimental group

Description:

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.

Treatment:

Procedure: epinephrine solution injection

non-injection group

No Intervention group

Description:

In non injection group, the saline epinephrine solution is not given