NCT00124202

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

1.6 years

First QC Date

July 25, 2005

Last Update Submit

July 29, 2013

Conditions

Biliary Tract Disease

Keywords

a fatty mealERCP

Outcome Measures

Primary Outcomes (1)

  • a fatty meal in the study group and normal saline in control group

    the procedure time for ERCP

Secondary Outcomes (1)

  • follow up within 3 days for complication with relation to the cannulation time

    within 3 days

Study Arms (1)

a fatty meal vs normal saline

PLACEBO COMPARATOR

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

Interventions

a fatty mealBEHAVIORAL

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

a fatty meal vs normal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients, 18 years and older, who are scheduled for ERCP at Emory University Hospital and signed consent before the procedure.

You may not qualify if:

  • Patients with a known allergy to milk or those who choose not to sign the consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University School of Medicine; Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Biliary Tract Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Qiang Cai, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2005

First Posted

July 27, 2005

Study Start

May 1, 2003

Primary Completion

December 1, 2004

Study Completion

May 1, 2007

Last Updated

July 31, 2013

Record last verified: 2013-07

Locations

US(1)