Perihilar cholangiocarcinoma (pCCA), galbladder carcinoma (GBC), intrahepatic cholangiocarcinoma (iCCA)
Conditions
Interventions
Preprocedural intravenous antibiotic prophylaxis is administered (cefuroxime 1500 mg/metronidazole 500 mg
conform institutional ERCP protocol). An interventional radiologist performs the percutaneous transhepatic biliary drainage, by bridging significant ductal strictures by self-expandable fenestrated me
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: • Written informed consent must be given according to ICH/GCP, and national/local regulations. • Unresectable primary malignant perihilar obstruction on imaging with histopathological confirmation or high clinical suspicion (as determined by the multidisciplinary hepatobiliary team) And • Symptomatic hyperbilirubinemia (a combination of a total bilirubin level >100 mmol/l, and/or jaundice and/or loss of appetite and/or dark urine and/or steatorrhea) Or • Age > 70 years
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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 both fever (i.e. body temperature >38.5°C) and leucocytosis (i.e. =10 *109/L) without clinical or radiological evidence of acute cholecystitis (14). Patients who underwent ERCP are eligible, providing no papillotomy was performed or stent was placed and there are no signs of cholangitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives: 6-months overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): • Stent-related complications according to Clavien-Dindo grading system within 90 days; • Absolute and relative (%) bilirubin decrease after 14 days; • Number of scheduled and unscheduled reinterventions within 90 days. • Infectious biliary complications (i.e. cholangitis and cholecystitis); • Technical success of stent placement at initial drainage procedure. • Bile culture results. • Proportion of patients that started with palliative chemotherapy; • Cost-effectiveness. • Quality of Life (QoL). – for expansion cohort only | — |
Contacts
Public ContactStijn Franssen
Erasmus MC
Outcome results
None listed