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

Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients with Transient Bleeding During ERCP

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04964869

Enrollment

400

Registered

2021-07-16

Start date

2021-07-15

Completion date

2030-12-31

Last updated

2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding Hemorrhage

Keywords

sphincterotomy, epinephrine solution

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.

Interventions

PROCEDUREepinephrine solution injection

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
post EST bleeding rate	30 days	delay post-sphincterotomy bleeding rate

Countries

Taiwan

Contacts

Primary ContactShih-Chieh Chuang, MD

D18114@mail.cmuh.org.tw+886-975680839

Backup ContactWen-Hsin Huang, MD

u97766.huang@msa.hinet.net+886-4-2205-2121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026