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NCT02442167 Clinical Trial

Performance of FISH for the Diagnosis of Malignant Biliary Strictures in Thai Patients

Malignancy Clinical Trial

Official title:
Fluorescence in Situ Hybridization (FISH) Improves Performance of Conventional Cytology for the Diagnosis of Malignant Biliary Tract Strictures in Thai Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02442167
Other study ID # 14-008579
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2010
Est. completion date December 2014

Study information
Verified date December 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators conducted a prospective study in 2 university hospitals to determine diagnostic performance of FISH for the diagnosis of malignant biliary strictures in Thai patients.

Description:

Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators aimed to compare the sensitivity of FISH and conventional cytology for the diagnosis of malignant biliary strictures in Thai patients. A prospective study was performed in 2 university hospitals between 2010 and 2013. Patients being evaluated for malignant-appearing biliary strictures were included. Bile duct brushings were collected and assessed by cytology and FISH. Sensitivities with 95% confidence intervals of cytology and FISH were main outcome measurements.

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date December 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 years - Clinical suspicion of malignant biliary tract strictures

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Chulalongkorn University

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivities with 95% confidence intervals of FISH Sensitivities with 95% confidence intervals of FISH and routine cytology will be compared Up to 12 months
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