bile duct cancer Malignant hilar biliary obstruction
Conditions
Interventions
PPS to bridge the MHBO with self-expandable fenestrated metal stents without
crossing the ampulla and without leaving an external drain.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Written informed consent must be given according to ICH/GCP and national/local regulations. And • MHBO on imaging with histopathological confirmation or high clinical suspicion. And • Ineligible for surgical resection. And • Hyperbilirubinemia (a combination of a total bilirubin level >50 mmol/l.
Exclusion criteria
Exclusion criteria: • Fluctuation or spontaneous decrease of a total bilirubin level before start of any treatment suggesting a potential non-malignant diagnosis. • Patients who underwent previous biliary drainage procedures endoscopically or percutaneously. Patients who underwent an attempted but failed ERCP are eligible only when no papillotomy or cannulation was performed. • Clinical signs of cholangitis. Cholangitis is defined as the presence of both fever (i.e. body temperature >38.5°C) and leucocytosis (i.e. >=10 *109/L) without clinical or radiological evidence of acute cholecystitis (22). • Uncorrectable coagulation disorder. • Uncorrectable contrast allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major complications within 90 days after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| The total number of severe drainage-related complications within 90 days after randomisation, OS, absolute and relative (%) total bilirubin decrease after 14 days (+/- 4 days), the proportion of patients with technical success of stent placement at initial drainage procedure, the proportion of patient with successful drainage at initial drainage procedure, the number of reinterventions within 90 days after randomization that involved (attempted) stent (re-)placement, the number of hospital admission days within 90 days after randomization, the proportion of patients requiring crossover treatment, the proportion of patients that become eligible for palliative chemotherapy, QoL and cost-effectiveness. | — |
Countries
Netherlands
Outcome results
None listed