Back to resultsEffect of a Fatty Meal on Endoscopic Retrograde Cholangiopancreatography (ERCP)
Primary Purpose
Biliary Tract Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
a fatty meal
Sponsored by
About this trial
This is an interventional diagnostic trial for Biliary Tract Disease focused on measuring a fatty meal, ERCP
Eligibility Criteria
Inclusion Criteria: Patients, 18 years and older, who are scheduled for ERCP at Emory University Hospital and signed consent before the procedure. Exclusion Criteria: Patients with a known allergy to milk or those who choose not to sign the consent.
Sites / Locations
- Emory University School of Medicine; Emory University Hospital
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
a fatty meal vs normal saline
Arm Description
Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group
Outcomes
Primary Outcome Measures
a fatty meal in the study group and normal saline in control group
Secondary Outcome Measures
follow up within 3 days for complication with relation to the cannulation time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00124202
Brief Title
Effect of a Fatty Meal on Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official Title
Effect of a Fatty Meal on Cannulation at Endoscopic Retrograde Cholangiopancreatography
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to determine if a fatty meal would improve the ERCP procedure.
Detailed Description
A fatty meal is a potent stimulator of cholecystikinin (CCK) in human body. The biological effect of CCK is increasing bile secretion and relaxing the sphincter of Oddi. Theoretically, a fatty meal should facilitate the effect on cannulation at ERCP. If a fatty meal can make the major papilla cannulation easier, it may significantly shorten the procedure time for ERCP and even decrease complications of the procedure, since the complication rate of post-ERCP is positively related to the time of the procedure.
Comparison: Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Disease
Keywords
a fatty meal, ERCP
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
a fatty meal vs normal saline
Arm Type
Placebo Comparator
Arm Description
Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group
Intervention Type
Behavioral
Intervention Name(s)
a fatty meal
Intervention Description
Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group
Primary Outcome Measure Information:
Title
a fatty meal in the study group and normal saline in control group
Time Frame
the procedure time for ERCP
Secondary Outcome Measure Information:
Title
follow up within 3 days for complication with relation to the cannulation time
Time Frame
within 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients, 18 years and older, who are scheduled for ERCP at Emory University Hospital and signed consent before the procedure.
Exclusion Criteria:
Patients with a known allergy to milk or those who choose not to sign the consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Cai, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine; Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of a Fatty Meal on Endoscopic Retrograde Cholangiopancreatography (ERCP)
We'll reach out to this number within 24 hrs