indeterminate and suspicious biliary strictures
Conditions
Interventions
Group 1: Any patient = 18 years with an indeterminate or suspicious stricture of the perihilar or distal bile duct with an indication for endoscopic retrograde cholangiography (ERC).
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Indication for ERC as a diagnostic work-up for a stricture of the perihilar or extrahepatic bile duct categorized as indeterminate or suspicious for malignancy. 2. For patients with a diagnosis of primary sclerosing cholangitis, the stricture must be new and meet the definition of clinically relevant (>75% reduction of duct diameter in the common bile duct or hepatic ducts on MRI/MRCP with signs or symptoms of obstructive cholestasis and/or bacterial cholangitis). 3. Ability of patient to understand character and individual consequences of study. 4. Written informed consent (must be available before enrollment in the study).
Exclusion criteria
Exclusion criteria: 1. Any medical condition that is a contraindication to perform ERC. 2. Indication for ERC for non-biliary malignancy. 3. Prior NGS-based analysis of biopsy tissue from the stricture or bile or intended during the routine diagnostic work-up prior to a cytologic/or histologic confirmed diagnosis. 4. Metastatic disease. 5. Held in an institution by legal or official order. 6. Legally incapacitated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic performance of BileCapture compared to standard diagnostic methods. This endpoint evaluates the benefit of next generation sequencing (NGS)-based mutation analysis of bile fluid samples for cancer diagnosis in patients with indeterminate biliary strictures. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy of cholangiocyte organoid expansion and comparison of mutational spectra with the data from BileCapture. 2. Efficacy of NGS mutation analysis of cell-free DNA/RNA from blood plasma samples (Liquid Biopsy). 3. Efficacy of AI-based prediction at the single test level and on an integrated multimodal level. | — |
Countries
Germany
Contacts
Public ContactMichael Dill
Universitätsklinikum Heidelberg
Outcome results
None listed