Ultrasound for Diagnosis of Biliary Dyskinesia

This study has been terminated.

(PI left institution, study interest wained-so stopped.)

Sponsor:

Information provided by:

Texas Tech University Health Sciences Center

ClinicalTrials.gov Identifier:

NCT00737295

First received: August 14, 2008

Last updated: November 15, 2010

Last verified: November 2010

History of Changes

Purpose

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	Intervention
Biliary Dyskinesia	Procedure: CCK Injection and Ultrasound

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Study to Investigate the Role of Ultrasound for Diagnosis of Biliary Dyskinesia

Resource links provided by NLM:

MedlinePlus related topics: Nuclear Scans

U.S. FDA Resources

Further study details as provided by Texas Tech University Health Sciences Center:

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. [ Time Frame: After HIDA scan performed ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	May 2008
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received:	August 14, 2008
Last Updated:	November 15, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:

Biliary
Dyskinesia
Gallbladder
Cholecystitis

Additional relevant MeSH terms:

Biliary Dyskinesia
Dyskinesias
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013

To Top