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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02442167
Collaborator
Chulalongkorn University (Other)
101
Enrollment
57
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    101 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Fluorescence in Situ Hybridization (FISH) Improves Performance of Conventional Cytology for the Diagnosis of Malignant Biliary Tract Strictures in Thai Patients
    Study Start Date :
    Mar 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivities with 95% confidence intervals of FISH [Up to 12 months]

      Sensitivities with 95% confidence intervals of FISH and routine cytology will be compared

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age > 18 years

    • Clinical suspicion of malignant biliary tract strictures

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mayo Clinic
    • Chulalongkorn University

    Investigators

    • Principal Investigator: Lewis R Roberts, MB, ChB, PhD, Mayo Clinic, Rochester, MN, USA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lewis R. Roberts, PI, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02442167
    Other Study ID Numbers:
    • 14-008579
    First Posted:
    May 13, 2015
    Last Update Posted:
    May 13, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Constriction, Pathologic

    Study Results

    No Results Posted as of May 13, 2015