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

Emory University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Biliary Tract Disease

Treatments: Behavioral: a fatty meal

Study type: Interventional

Funder types: Other

Identifiers

NCT00124202

229-2003

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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80 participants in 1 patient group, including a placebo group

a fatty meal vs normal saline

Placebo Comparator group

Description:

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

Treatment:

Behavioral: a fatty meal