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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Emory University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00124202
First received: July 25, 2005
Last updated: September 8, 2006
Last verified: September 2006
History of Changes
  Purpose

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


Condition Intervention
Biliary Tract Disease
 Behavioral: a fatty meal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Effect of a Fatty Meal on Cannulation at Endoscopic Retrograde Cholangiopancreatography

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • the facilitative effect of a fatty meal on major papilla by measuring the cannulation time; the amount of x-ray exposure during the procedure

Secondary Outcome Measures:
  • follow up within 3 days for complication with relation to the cannulation time

Estimated Enrollment: 200
Study Start Date: May 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124202

Contacts
Contact: Qiang Cai, MD, PhD 404-778-4857 qcai@emory.edu

Locations
United States, Georgia
Emory University School of Medicine; Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Qiang Cai, MD, PhD     404-778-4857     qcai@emory.edu    
Principal Investigator: Qiang Cai, MD, PhD            
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Qiang Cai, MD, PhD Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00124202     History of Changes
Other Study ID Numbers: 229-2003
Study First Received: July 25, 2005
Last Updated: September 8, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
a fatty meal
ERCP

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013