Effect of a Fatty Meal on Endoscopic Retrograde Cholangio... | NCT00124202

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

NCT00124202

Sponsor

Emory University

Status

Completed

Last Update Posted

Jul 31, 2013Estimated

Enrollment

80Actual

Phase

Phase 1Phase 2

Conditions

Biliary Tract Disease

Interventions

a fatty meal

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Dec 2004Actual

Completion Date

May 2007Actual

First Submitted Date

Jul 25, 2005

First Submission Date that Met QC Criteria

Jul 25, 2005

First Posted Date

Jul 27, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2013

Last Update Posted Date

Jul 31, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
a fatty meal	Behavioral	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
a fatty meal in the study group and normal saline in control group		the procedure time for ERCP

Secondary Outcomes

Measure	Description	Time Frame
follow up within 3 days for complication with relation to the cannulation time		within 3 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Qiang Cai, MD, PhD	Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University School of Medicine; Emory University Hospital		Atlanta	Georgia	30322	United States

Condition Browse Module

MeSH Terms

ID	Term
D001660	Biliary Tract Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided