cancer of the bile ducts Cholangiocarcinoma
Conditions
Interventions
Unilateral endoscopic drainage of the future liver remnant using a removable
FCSEMS (length 4 cm
diameter 8 mm).
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with presumed perihilar cholangiocarcinoma that are judged eligible for major liver resection and require endoscopic biliary drainage of the future liver remnant.
Exclusion criteria
Exclusion criteria: - Incompletely recovered from any side effects of previous biliary drainage procedures - Any contra-indication for major liver surgery - Technical contra-indications for endobiliary drainage - Requirement of multiple stents for adequate drainage of the future liver remnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: number of severe drainage related complications between inclusion and exploratory laparotomy. In patients who will not undergo exploratory laparotomy, the number of drainage-related complications will be measured until 7 days after the decision to cancel exploratory laparotomy or 90 days after inclusion, whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome will include technical and therapeutic success of biliary drainage, individual components of primary endpoints and quality of life. | — |
Countries
Netherlands
Outcome results
None listed