Biliary Stricture Clinical Trial
Official title:
Fluorescent in Situ Hybridization in Diagnosis of Biliary Stricture: A Feasibility Study
NCT number | NCT04391153 |
Other study ID # | UHO003 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 3, 2020 |
Est. completion date | December 19, 2021 |
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.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | December 19, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: 1. Suspected malignant biliary stricture 2. Localization: Extrahepatic biliary duct 3. Patient´s consent with a diagnostic procedure 4. Age : 18 years or more Exclusion Criteria: 1. Intrahepatic biliary strictures 2. Duodenal stenosis (endoscopically) 3. Age : < 18 years 4. Coagulopathy : (INR >1,5, Platelets < 100) 5. Pregnancy |
Country | Name | City | State |
---|---|---|---|
Czechia | 2nd Department of Internal Medicine, University Hospital and Palacký University, | Olomouc |
Lead Sponsor | Collaborator |
---|---|
University Hospital Olomouc |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | evaluate the impact of FISH on management of patients with biliary stricture. | The proportion of patients (%) who will miss the chance of curative surgery for some malignancy and the proportion of patients (%) who will not have unnecessary surgery for benign etiologies are evaluated. | 3-6 months |
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