FISH in Diagnosis of Biliary Stricture

NCT04391153 | Unknown DMC

• 1 other identifier: UHO003
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

suspected malignant biliary stricture; fluorescence in situ hybridization; endoscopic retrograde cholangiopancreatography; brushing; forceps biopsy; endosonography/ EUS-FNA

Outcome Measures

Primary Outcomes (1)

• Proove the feasebility and the clinical place of FISH in the diagnostic of biliary strictures

  The the sensitivity (%) and specificity (%) of ERCP/ EUS with conventional tissue sampling - Brushing, forceps biopsy/EUS-FNA and ERCP/EUS with conventional tissue sampling completed with FISH in patients with suspected malignant stricture of the common bile duct are evaluated. Success (positivity) is defined by the presence of benign or malignant cells, adequate to make the final tissue diagnosis. Based on the previous studies and the experiences of our endoscopists and pathologist, we can expect the diagnostic yield with FISH will be increased of 20-30% in the study population (the samples size 96).

  1- 7 days

Secondary Outcomes (1)

• evaluate the impact of FISH on management of patients with biliary stricture.

  3-6 months

Study Arms (2)

conventional samplig

ACTIVE COMPARATOR

Patients with biliary strictures udergo ERCP or 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. 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.

Procedure: ERCP with tissue sampling

Fluorescence in situ Hybridization (FISH)

ACTIVE COMPARATOR

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.

Procedure: ERCP with tissue sampling

Interventions

ERCP with tissue sampling PROCEDURE

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.

Fluorescence in situ Hybridization (FISH); conventional samplig

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected malignant biliary stricture
• Localization: Extrahepatic biliary duct
• Patient´s consent with a diagnostic procedure
• Age : 18 years or more

You may not qualify if:

• Intrahepatic biliary strictures
• Duodenal stenosis (endoscopically)
• Age : \< 18 years
• Coagulopathy : (INR \>1,5, Platelets \< 100)
• Pregnancy

Sponsors & Collaborators

• University Hospital Olomouc: lead

Study Sites (1)

2nd Department of Internal Medicine, University Hospital and Palacký University,

Olomouc, 771 00, Czechia

RECRUITING

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Vincent Zoundjiekpon, MD

  2nd Department of Internal Medicine, University Hospital Olomouc, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Zoundjiekpon, MD

CONTACT

00420608080209; vincent04@post.cz

Ondrej Urban, MD, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 18, 2020
• Study Start: May 3, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 19, 2021
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)