Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2021
CompletedStudy Start
First participant enrolled
July 15, 2021
CompletedFirst Posted
Study publicly available on registry
July 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
October 24, 2024
October 1, 2024
9.4 years
July 8, 2021
October 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
post EST bleeding rate
delay post-sphincterotomy bleeding rate
30 days
Study Arms (2)
Epinephrine solution injection group
EXPERIMENTALIn 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.
non-injection group
NO INTERVENTIONIn non injection group, the saline epinephrine solution is not given
Interventions
epinephrine solution injection at least 1 ml to the post- sphincterotomy wound
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wen-Hsin Huanglead
Study Sites (1)
China Medical University Hospital
Taichung, North Dist., 404332, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wen-Hsin Huang, MD
China Medical University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Gastroenterology and Hepatology Deputy Director
Study Record Dates
First Submitted
July 8, 2021
First Posted
July 16, 2021
Study Start
July 15, 2021
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
October 24, 2024
Record last verified: 2024-10