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

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.

Study Overview

• Status: Completed
• Conditions: Malignancy; Bile Duct Stricture

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 Type: Observational
• Enrollment (Actual): 101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients being evaluated for malignant appearing biliary tract strictures who undergo ERCP

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Chulalongkorn University
• Investigators: Principal Investigator: Lewis R Roberts, MB, ChB, PhD, Mayo Clinic, Rochester, MN, USA

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (Estimated): May 13, 2015

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: 14-008579