Ultrasound for Diagnosis of Biliary Dyskinesia

Not Applicable

Terminated

• Conditions: Biliary Dyskinesia
• Interventions: Procedure: CCK Injection and Ultrasound

• Registration Number: NCT00737295
• Lead Sponsor: Texas Tech University Health Sciences Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-15
• Study First Posted: 2008-08-18
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-15
• Last Update Posted: 2010-11-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
US	CCK Injection and Ultrasound	There will be no experimental or control group, rather each individual will act as his/her own control.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States