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Ultrasound for Diagnosis of Biliary Dyskinesia

Primary Purpose

Biliary Dyskinesia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CCK Injection and Ultrasound
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Biliary Dyskinesia focused on measuring Biliary, Dyskinesia, Gallbladder, Cholecystitis

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

US

Arm Description

There will be no experimental or control group, rather each individual will act as his/her own control.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2008
Last Updated
November 15, 2010
Sponsor
Texas Tech University Health Sciences Center
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1. Study Identification

Unique Protocol Identification Number
NCT00737295
Brief Title
Ultrasound for Diagnosis of Biliary Dyskinesia
Official Title
Study to Investigate the Role of Ultrasound for Diagnosis of Biliary Dyskinesia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
PI left institution, study interest wained-so stopped.
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Texas Tech University Health Sciences Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Dyskinesia
Keywords
Biliary, Dyskinesia, Gallbladder, Cholecystitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
US
Arm Type
Experimental
Arm Description
There will be no experimental or control group, rather each individual will act as his/her own control.
Intervention Type
Procedure
Intervention Name(s)
CCK Injection and Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Written informed consent document. Males and Females age > 18 years Exclusion Criteria: Subjects without a suspected clinical diagnosis of biliary dyskinesia, including an ultrasound that demonstrates biliary wall thickness of > 3 mm, and/or gallstones present. Pregnant or breastfeeding women Subjects who do not consent to take part in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Warren, MD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States

12. IPD Sharing Statement

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Ultrasound for Diagnosis of Biliary Dyskinesia

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