Klatskin tumor perihilar bile duct tumor Perihilar cholangiocarcinoma
Conditions
Interventions
The index drainage procedure is scheduled at 5 days after treatment allocation.
EBD consists of an endoscopic retrograde cholangiography and placement of a
plastic endoprosthesis through the stenosi
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of perihilar cholangiocarcinoma • No apparent signs of irresectability on CT-scan and/or MRI, and scheduled to undergo a *curative* liver resection (may need additional lymph node biopsies or a diagnostic laparoscopy to further determine resectability); • Inadequate preoperative biliary drainage. For drainage naïve patients this is defined as: * Serum bilirubin level >= 50 µmol/l; For drainage non-naïve patients this is defined as: * Persistent hyperbilirubinemia * or inadequate drainage of the future remnant liver (stent positioned in contra-lateral side) • Both the endoscopic and the percutaneous drainage methods are technically feasible.
Exclusion criteria
Exclusion criteria: • Incomplete recovery from side-effects of any prior stenting attempt, including signs of active cholangitis. • ECOG/WHO score >=3 • Any other contraindication for major liver surgery • No informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of drainage related complications between treatment allocation and explorative laparotomy. Complications in this composite endpoint are consist of: - Stent dysfunction - Cholangitis - Acute cholecystitis - Acute pancreatitis - Hemorrhage - Perforation - Portal vein thrombosis - Dehydration | — |
Secondary
| Measure | Time frame |
|---|---|
| - The individual components of the primary endpoint, with special interest to the incidence of preoperative cholangitis; - The number of drainage procedures required to achieve technical success; - The total number of drainage procedures that involved (attempts at) stent (re-)placement; - The proportion of patients with therapeutic success at 7 days after technical success; - The interval bilirubin decrease at 7 days and 14 days after technical success, relative to the reference level at randomization; - The bilirubin level at explorative laparotomy; - The number of days between randomization and explorative laparotomy; - The number of patients with rescheduled or cancelled laparotomy for clinical reasons; - Quality of Life (for details about QOL assessment please refer to §9); - Post-laparotomy mortality, defined as 90-day mortality after explorative laparotomy; - Post-laparotomy morbidity, defined as any complication from table 3 that occurs within 90 days after explorative laparotomy. | — |
Countries
Netherlands
Outcome results
None listed