- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02839356
Epinephrine Sprayed on the Papilla for the Prevention of Post-ERCP Pancreatitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Anhui
-
He Fei, Anhui, China, 230001
- Recruiting
- Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
-
Principal Investigator:
- Shao Feng, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females, age > 18 years.
- Normal amylase level before undergoing ERCP.
- Signed inform consent form and agreed to follow-up on time.
Exclusion Criteria:
- Pregnancy or history of allergy to epinephrine.
- Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
- Patients involved in other study within 60 days.
- Billroth II or Roux-en-Y anatomy
- Acute pancreatitis.
- All contraindications to epinephrine.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug: epinephrine
20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla
|
20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla
|
Placebo Comparator: Drug: normal saline
20-mL irrigation with physiological saline over the entire papilla
|
20-mL irrigation with physiological saline over the entire papilla
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The prophylaxis effect of epinephrine sprayed on the papilla on post-ERCP pancreatitis
Time Frame: PEP occurence rate at 24 h after ERCP in two groups.
|
If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis). Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables. Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables. |
PEP occurence rate at 24 h after ERCP in two groups.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare epinephrine group with control group on the incidence of hyperamylasemia/adverse events.
Time Frame: the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups
|
Hyperamylasemia will be defined as the serum amylase 3 times more than the upper normal values, without clinical symptoms. During the study, any unexpected medical issue will be called adverse event. Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables. |
the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Shao Feng, MD, Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pancreatic Diseases
- Pancreatitis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
Other Study ID Numbers
- Epinephrine001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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