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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00124202
First Posted: July 27, 2005
Last Update Posted: July 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Qiang Cai MD/PhD, Emory University
  Purpose
This study is to determine if a fatty meal would improve the ERCP procedure.

Condition Intervention Phase
Biliary Tract Disease Behavioral: a fatty meal Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of a Fatty Meal on Cannulation at Endoscopic Retrograde Cholangiopancreatography

Further study details as provided by Dr. Qiang Cai MD/PhD, Emory University:

Primary Outcome Measures:
  • a fatty meal in the study group and normal saline in control group [ Time Frame: the procedure time for ERCP ]

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

Enrollment: 80
Study Start Date: May 2003
Study Completion Date: May 2007
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: a fatty meal vs normal saline
Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124202


Locations
United States, Georgia
Emory University School of Medicine; Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Qiang Cai, MD, PhD Emory University
  More Information

Responsible Party: Dr. Qiang Cai MD/PhD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00124202     History of Changes
Other Study ID Numbers: 229-2003
First Submitted: July 25, 2005
First Posted: July 27, 2005
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by Dr. Qiang Cai MD/PhD, Emory University:
a fatty meal
ERCP

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases