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OpenTrials
Completed

NCT Number: NCT02442167

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

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.

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Key information

Conditions

Bile Duct Stricture Malignancy Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Clinical suspicion of malignant biliary tract strictures

Treatment and study plan

Primary outcomes

  1. Sensitivities with 95% confidence intervals of FISH

    Time frame: Up to 12 months

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Chulalongkorn University

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
May 13, 2015
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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