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Ultrasound for Diagnosis of Biliary Dyskinesia

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ClinicalTrials.gov Identifier: NCT00737295
Recruitment Status : Terminated (PI left institution, study interest wained-so stopped.)
First Posted : August 18, 2008
Last Update Posted : November 16, 2010
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Biliary Dyskinesia Procedure: CCK Injection and Ultrasound

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study to Investigate the Role of Ultrasound for Diagnosis of Biliary Dyskinesia
Study Start Date : May 2008
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arms and Interventions

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.



Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737295


Locations
United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Thomas Warren, MD Texas Tech University Health Sciences Center
More Information

Responsible Party: Thomas Warren, MD, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00737295     History of Changes
Other Study ID Numbers: TT Biliary Dyskinesia
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: November 2010

Keywords provided by Texas Tech University Health Sciences Center:
Biliary
Dyskinesia
Gallbladder
Cholecystitis

Additional relevant MeSH terms:
Dyskinesias
Biliary Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases