Resectable perihilar cholangiocarcinoma Bile duct cancer in the liver hilum that can be surgically removed
Conditions
Interventions
Primary percutaneous stenting with fenestrated self-expandable metal stents (SEMS) without crossing the ampulla and without leaving an external drain after stent placement.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Written informed consent must be given according to ICH/GCP, and national/local regulations. • Resectable pCCA on imaging with histopathological confirmation or high clinical suspicion (as determined by the multidisciplinary hepatobiliary team). • Hyperbilirubinemia (a combination of a total bilirubin level >50 mmol/l. • Age above 18 years
Exclusion criteria
Exclusion criteria: • Fluctuation or spontaneous decrease of a total bilirubin level before start of any treatment suggesting potential benign origin. • Patients who underwent previous drainage procedures endoscopically or percutaneously with an internalized biliary catheter. • Clinical signs of cholangitis. Cholangitis was defined as the presence of both fever (i.e. body temperature >38.5°C) combined with leucocytosis (i.e. >=10 *109/L) without clinical or radiological evidence of acute cholecystitis • Uncorrectable coagulation disorder. • Uncorrectable contrast allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major complications within 90 days after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe drainage-related complications within 90 days after inclusion; absolute and relative (%) bilirubin decrease after 14 days (+/-4 days); proportion of patients with technical success of stent placement at initial drainage procedure; proportion of patients with successful drainage at initial drainage procedure; number of reinterventions and hospital admission days; proportion of patients who underwent surgical exploration and who underwent curative-intent surgical resection; proportion of uncomplicated stent removal from the future liver remnant during surgery; overall survival (OS); bile cultures; presence of circulating tumour DNA (ctDNA); and cost-effectiveness. | — |
Countries
Netherlands
Contacts
Public ContactB. Groot Koerkamp
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed