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

Biliary Tract Disease Clinical Trial

Official title:

Effect of a Fatty Meal on Cannulation at Endoscopic Retrograde Cholangiopancreatography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124202
• Other study ID #: 229-2003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 25, 2005
• Last updated: July 29, 2013
• Start date: May 2003
• Est. completion date: May 2007

Study information

• Verified date: July 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is to determine if a fatty meal would improve the ERCP procedure.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2007
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Biliary Tract Disease
• Biliary Tract Diseases

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Emory University School of Medicine; Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a fatty meal in the study group and normal saline in control group		the procedure time for ERCP	Yes
Secondary	follow up within 3 days for complication with relation to the cannulation time		within 3 days	Yes