Indeterminate biliary stricture
Conditions
Interventions
Multiple cholangioscopy-guided random biopsies and bite-on-bite(-on-bite) biopses of an indeterminate biliary stricture
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: - Male or female > 18 years old - Presence of an indeterminate biliary stricture, defined as: 1. A bile duct stricture or filling defect of indeterminate nature after previous laboratory work-up, abdominal imaging (MRI, CT, endoscopic ultrasound) or ERCP, and/or; 2. Negative or inconclusive cytology or histology after ERCP with brush cytology or intra-ductal biopsies, and/or; 3. Despite benign cytology or histology findings persistent strong suspicion of a malignant aetiology based on clinical symptoms such as abdominal pain, unexpected weight loss, loss of appetite and obstructive jaundice. - Written informed consent
Exclusion criteria
Exclusion criteria: - Contraindication for ERCP or SOC (i.e. suspicion of ascending cholangitis or of acute pancreatitis) - Contraindication for biopsy (i.e. known coagulation disorder) - No written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity and accuracy | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Contacts
Public ContactDavid de Jong
Erasmus University MC
Outcome results
None listed