Ultrasound for Diagnosis of Biliary Dyskinesia - Full Text View

Sponsored by:	Texas Tech University Health Sciences Center
Information provided by:	Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00737295

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

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Nuclear Scans Ultrasound

Drug Information available for: Sincalide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Study to Investigate the Role of Ultrasound for Diagnosis of Biliary Dyskinesia

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 ]

Estimated Enrollment:	50
Study Start Date:	May 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
US: Experimental 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

US: Experimental

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

Contacts

Contact: Cathy Lovett, MSN, RN,CCRC	806-743-4222 ext 308	cathy.lovett@ttuhsc.edu
Contact: Susan Doctolero, BSN, RN,CCRC	806-743-4222 ext 310	susan.doctolero@ttuhsc.edu

Locations

United States, Texas
Texas Tech University Health Sciences Center	Recruiting
Lubbock, Texas, United States, 79430
Principal Investigator: Thomas Warren, MD

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:	Texas Tech University Health Sciences Center ( Thomas Warren, MD )
Study ID Numbers:	TT Biliary Dyskinesia
Study First Received:	August 14, 2008
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00737295
Health Authority:	United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:

Biliary
Dyskinesia
Gallbladder
Cholecystitis

Study placed in the following topic categories:

Signs and Symptoms
Digestive System Diseases
Movement Disorders
Bile Duct Diseases
Acalculous Cholecystitis
Biliary Tract Diseases

Neurologic Manifestations
Central Nervous System Diseases
Cholecystitis
Dyskinesias
Biliary Dyskinesia

Additional relevant MeSH terms:

Common Bile Duct Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009