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FISH in Diagnosis of Biliary Stricture

NCT04391153 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2020-05-20

No results posted yet for this study

Summary

The management of biliary strictures depends on their correct pre-operative evaluation which remains challenging. Despite the emerging multitudes of new diagnostic opportunities- modalities we have today, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´ outcome. The study aims to proove the feasibility and to evaluate the impact of Fluorescent In Situ Hybridization (FISH) on the tissue diagnostic of biliary strictures.

Conditions

  • Biliary Stricture

Interventions

PROCEDURE

ERCP with tissue sampling

Patients with biliary strictures undergo ERCP o EUS. Tissue specimens obtained via either of brush cytology, forceps biopsy or fine needle aspiration during ERCP or endosonography (EUS) were examined by routine cytology or histology methods. In addition, FISH inlcuding fluorescence-based polynucleotide probes targeting chromosomes 3, 7, 17 and locus 9p21 was performed. Gold standard for final diagnosis is the histology from surgical resection. In patients without surgery, a follow up of 12 months will be considered adequate to exclude or confirm malignant etiology.

Sponsors & Collaborators

  • University Hospital Olomouc

    lead OTHER

Principal Investigators

  • Vincent Zoundjiekpon, MD · 2nd Department of Internal Medicine, University Hospital Olomouc, Czech Republic

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-03
Primary Completion
2020-12-31
Completion
2021-12-19

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04391153 on ClinicalTrials.gov