Efficacy of Prophylactic Epinephrine Solution Injection i... | NCT04964869

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

NCT04964869

Sponsor

Wen-Hsin Huang

Status

Recruiting

Last Update Posted

Oct 24, 2024Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Bleeding Hemorrhage

Interventions

epinephrine solution injection

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2021Actual

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Jul 8, 2021

First Submission Date that Met QC Criteria

Jul 8, 2021

First Posted Date

Jul 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2024

Last Update Posted Date

Oct 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wen-Hsin Huang, Gastroenterology and Hepatology Deputy Director, China Medical University HospitalSponsor-Investigator

Lead Sponsor

Wen-Hsin HuangOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epinephrine solution injection group	Experimental	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
non-injection group	No Intervention	In non injection group, the saline epinephrine solution is not given

Interventions

Name	Type	Description	Arm Group Labels	Other Names
epinephrine solution injection	Procedure	epinephrine solution injection at least 1 ml to the post- sphincterotomy wound	Epinephrine solution injection group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shih-Chieh Chuang, MD	Contact	+886-975680839		D18114@mail.cmuh.org.tw
Wen-Hsin Huang, MD	Contact	+886-4-2205-2121	2233	u97766.huang@msa.hinet.net

Overall Officials

Name	Affiliation	Role
Wen-Hsin Huang, MD	China Medical University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University Hospital	Recruiting	Taichung	North Dist.	404332	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided