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Ultrasound for Diagnosis of Biliary Dyskinesia

NCT ID: NCT00737295

Last Updated: 2010-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-06-30

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.

Detailed Description

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Conditions

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Biliary Dyskinesia

Keywords

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Biliary Dyskinesia Gallbladder Cholecystitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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US

There will be no experimental or control group, rather each individual will act as his/her own control.

Group Type EXPERIMENTAL

CCK Injection and Ultrasound

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Tech University Health Sciences Center

OTHER

Sponsor Role lead

Responsible Party

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Texas Tech University Health Sciences Center

Principal Investigators

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Thomas Warren, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center

Locations

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Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TT Biliary Dyskinesia

Identifier Type: -

Identifier Source: org_study_id