Biliary Stricture, Biliary Tract Diseases, Biliary Tract Neoplasms, Neoplasms
Conditions
Keywords
Endosonography, Endoscopic retrograde choledochography
Brief summary
ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some of these shortcomings. The current prospective study, performed in a tertiary University center, aims to study the feasibility, the accuracy and the clinical value of combinatory ERCP and EUS in unclear biliary lesions.
Detailed description
The eligible study participants with unclear biliary lesions referred for an ERCP to the Sahlgrenska Univeristy Hospital endoscopy unit will be subjected to ERCP with/without brush cytology followed by EUS with/without FNA. The results of ERCP and EUS will be compared to the pathology report of surgical specimens in resected patients or to clinical follow up at 12 months post-EUS in non-resected patients.
Interventions
PROCEDURECombinatory EUS and ERCP
EUS performed as a supplementary procedure in addition to ERCP
Sponsors
Sahlgrenska University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with unclear lesions or strictures in the biliary tract referred for endoscopy work up
Exclusion criteria
* Patients unwilling to participate * Patients unfit for EUS and ERCP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | 12 months post-EUS | Overall accuracy of ERCP and EUS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | 30 days post-EUS | The number of patients ending up with some type of complication related to ERCP or EUS |
Countries
Sweden
Outcome results
None listed