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NCT00737295·Not applicable·INTERVENTIONAL

Ultrasound for Diagnosis of Biliary Dyskinesia

SincalideOtherTerminated

Status

Terminated

Phase

Not applicable

Enrollment

25

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Aug 18, 2008

  2. Study start

    May 2008

  3. Primary completion

    Jun 2010

  4. Study completion

    Jun 2010

  5. Results posted

    Not reported

  6. Registry updated

    Nov 16, 2010

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
89 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

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