Biliary obstruction (malignant)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Radiographically (CT, EUS) distal malignant bile duct obstruction - Histology or cytology proven malignancy of the primary tumour or metastasis; onsite cytology evaluation after EUS guided fine-needle sampling that is highly suspected of a malignancy suffices - Indication for biliary drainage; in case of an resectable tumour this should be discussed during a clinical multidisciplinary meeting - Written informed consent
Exclusion criteria
Exclusion criteria: - Age 1.5 or platelets
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is technical success. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint are clinical success, procedural time, adverse events, stent patency, need for reinterventions, technical outcome at pancreaticoduodenectomy (when applicable), and cost. | — |
Countries
Netherlands