Ultrasound for Diagnosis of Biliary Dyskinesia

November 15, 2010 updated by: Texas Tech University Health Sciences Center

Study to Investigate the Role of Ultrasound for Diagnosis of Biliary Dyskinesia

This is a prospective, non-randomized study of 50 people with suspected biliary dyskinesia. The purpose of this study is to investigate if it is possible to use ultrasound to make a diagnosis of a condition called biliary dyskinesia. The investigators null hypothesis is that there will be no statistical difference between the proposed experimental test (Ultrasound) and the HIDA scan (a nuclear medicine hepatobiliary system scan) in the diagnosis of biliary dyskinesia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 87 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All subjects will have a suspected clinical diagnosis of biliary dyskinesia, including an ultrasound that demonstrates biliary wall thickness of < 3 mm, and no gallstones present.
  2. Written informed consent document.
  3. Males and Females age > 18 years

Exclusion Criteria:

  1. Subjects without a suspected clinical diagnosis of biliary dyskinesia, including an ultrasound that demonstrates biliary wall thickness of > 3 mm, and/or gallstones present.
  2. Pregnant or breastfeeding women
  3. Subjects who do not consent to take part in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: US
There will be no experimental or control group, rather each individual will act as his/her own control.
Procedure: CCK Injection and Ultrasound

All subjects, whether they participate in this study or not, will undergo the HIDA scan as this is the accepted standard of care for diagnosing biliary dyskinesia. If a given subject agrees to participate in this study, he/she will be asked to undergo the following study procedures:

If a pregnancy test has not already been done, a urine pregnancy test will be done for women of childbearing potential.

An intravenous line (IV) will be inserted (if not already in place), and a standard dose of CCK (Kinevac®- 0.02 µg/kg) will then be injected according to the package insert. Ultrasound will be used to measure dimensions of the gallbladder (length, width and height) every minute for 35 minutes following injection of the CCK. This will be done by applying ultrasound jelly to the upper part of the abdomen and ultrasound probe will be used to obtain optimal images for three dimensional analysis of the subject's gallbladder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Does ultrasound test detect contraction of gallbladder following injection of a hormone cholecystokinin (CCK), and is the degree contraction as accurate as the accepted clinical standard (the HIDA scan) for diagnosis of biliary dyskinesia.
Time Frame: After HIDA scan performed
After HIDA scan performed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University Health Sciences Center

Investigators

  • Principal Investigator: Thomas Warren, MD, Texas Tech University Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (Estimate)

August 18, 2008

Study Record Updates

Last Update Posted (Estimate)

November 16, 2010

Last Update Submitted That Met QC Criteria

November 15, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TT Biliary Dyskinesia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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