Clinical trial NCT04964869: Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy
Official title: Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients with Transient Bleeding During ERCP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bleeding Hemorrhage
Keywords: sphincterotomy
epinephrine solution
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: post EST bleeding rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: North Dist.
Study officials:
affiliation: China Medical University Hospital
name: Wen-Hsin Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: