Effect of a Fatty Meal on Endoscopic Retrograde Cholangiopancreatography (ERCP)

Phase 1

Completed

• Conditions: Biliary Tract Disease
• Interventions: Behavioral: a fatty meal

• Registration Number: NCT00124202
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2004-12
• Study First Submitted: 2005-07-25
• Study First Submitted QC: 2005-07-25
• Study First Posted: 2005-07-27
• Study Completion: 2007-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients, 18 years and older, who are scheduled for ERCP at Emory University Hospital and signed consent before the procedure.

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Exclusion Criteria

• Patients with a known allergy to milk or those who choose not to sign the consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
a fatty meal vs normal saline	a fatty meal	Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group

Primary Outcome Measures

Name	Time	Method
a fatty meal in the study group and normal saline in control group	the procedure time for ERCP

Secondary Outcome Measures

Name	Time	Method
follow up within 3 days for complication with relation to the cannulation time	within 3 days

Trial Locations

Locations (1)

Emory University School of Medicine; Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States