No registrations found.
ID
Source
Brief title
Health condition
Indeterminate biliary stricture
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity, specificity and accuracy
Secondary outcome
Adverse events
Background summary
Single-operator cholangioscopy has shown promising results for detection of cholangiocarcinoma in indeterminate biliary strictures, with higher sensitivity rates for diagnosis through direct stricture visualisation suggested as compared to targeted biopsies. Biopsy protocols and tissue sampling techniques such as bite-on-bite biopsies for diagnosing indeterminate biliary strictures have not yet been systematically investigated. The diagnostic accuracy of tissue sampling by taking multiple biopsies and using the bite-on-bite technique will be investigated
Study objective
Both biopsy techniques are equally feasible
Study design
If benign pathology on biopsies, 1 year FU
Intervention
Multiple cholangioscopy-guided random biopsies and bite-on-bite(-on-bite) biopses of an indeterminate biliary stricture
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
- 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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9649 |
| Other | METC EMC : MEC-2018-1639 |