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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bleeding Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

epinephrine solution injection

Intervention Type PROCEDURE

epinephrine solution injection at least 1 ml to the post- sphincterotomy wound

non-injection group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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epinephrine solution injection

epinephrine solution injection at least 1 ml to the post- sphincterotomy wound

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No