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

Sponsor
Wen-Hsin Huang (Other)
Overall Status
Recruiting
CT.gov ID
NCT04964869
Collaborator
(none)
400
Enrollment
1
Location
2
Arms
20.5
Anticipated Duration (Months)
19.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: epinephrine solution injection
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy Bleeding in Patients With Transient Bleeding During ERCP
Actual Study Start Date :
Jul 15, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Procedure: epinephrine solution injection
epinephrine solution injection at least 1 ml to the post- sphincterotomy wound
No Intervention: non-injection group

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

Outcome Measures

Primary Outcome Measures

  1. post EST bleeding rate [30 days]

    delay post-sphincterotomy bleeding rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 China Medical University Hospital Taichung North Dist. Taiwan 404332

Sponsors and Collaborators

  • Wen-Hsin Huang

Investigators

  • Principal Investigator: Wen-Hsin Huang, MD, China Medical University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wen-Hsin Huang, Gastroenterology and Hepatology Deputy Director, China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT04964869
Other Study ID Numbers:
  • CMUH110-REC2-055
First Posted:
Jul 16, 2021
Last Update Posted:
Jul 26, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wen-Hsin Huang, Gastroenterology and Hepatology Deputy Director, China Medical University Hospital
sphincterotomy
epinephrine solution
Additional relevant MeSH terms:
Hemorrhage
Epinephrine

Study Results

No Results Posted as of Jul 26, 2021