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
|Condition or disease||Intervention/treatment||Phase|
|Biliary Dyskinesia||Procedure: CCK Injection and Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study to Investigate the Role of Ultrasound for Diagnosis of Biliary Dyskinesia|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
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.
- 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 ]
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
|United States, Texas|
|Texas Tech University Health Sciences Center|
|Lubbock, Texas, United States, 79430|
|Principal Investigator:||Thomas Warren, MD||Texas Tech University Health Sciences Center|