Ultrasound for Diagnosis of Biliary Dyskinesia

Study Overview
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Brief Summary
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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.

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

Conditions
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Biliary Dyskinesia

Intervention / Treatment
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* Procedure: CCK Injection and Ultrasound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | After HIDA scan performed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary, Dyskinesia, Gallbladder, Cholecystitis