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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Qiang Cai MD/PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00124202
First received: July 25, 2005
Last updated: July 29, 2013
Last verified: July 2013
  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: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of a Fatty Meal on Cannulation at Endoscopic Retrograde Cholangiopancreatography

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Qiang Cai MD/PhD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00124202     History of Changes
Other Study ID Numbers: 229-2003
Study First Received: July 25, 2005
Last Updated: July 29, 2013
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 August 20, 2014