NCT02442167

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

3.8 years

First QC Date

May 6, 2015

Last Update Submit

December 12, 2023

Conditions

Bile Duct StrictureMalignancy

Outcome Measures

Primary Outcomes (1)

  • Sensitivities with 95% confidence intervals of FISH

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

    Up to 12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Brush samples obtained from endoscopic retrograde cholangiopancreatography

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Lewis R Roberts, MB, ChB, PhD

    Mayo Clinic, Rochester, MN, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 13, 2015

Study Start

March 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

December 14, 2023

Record last verified: 2023-12