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

NCT ID: NCT00124202

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2007-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Biliary Tract Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

a fatty meal

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Qiang Cai MD/PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiang Cai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University School of Medicine; Emory University Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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229-2003

Identifier Type: -

Identifier Source: org_study_id

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