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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02442167

Enrollment

101

Registered

2015-05-13

Start date

2010-03-31

Completion date

2014-12-31

Last updated

2023-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Stricture, Malignancy

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \> 18 years * Clinical suspicion of malignant biliary tract strictures

Design outcomes

Primary

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

Outcome results