(Potentially) resectable perihilar cholanhiocarcinoma
Conditions
Interventions
Unilateral endoscopic drainage of the future liver remnant using a removable FCSEMS (Niti-S Kaffes Biliary stent, TaeWoong Medical Co., Ltd., Seoul, Korea).
Sponsors
Amsterdam UMC
Eligibility
Inclusion criteria
Inclusion criteria: - 18 years or older. - Capable of providing written and oral informed consent. - Presumed perihilar cholangiocarcinoma. - Biliary obstruction in the future liver remnant. - Drainage naïve patients: total bilirubin >50 umol/L - Patients with previous endobiliary drainage procedures: persistently rising total bilirubin >50 umol/L (i.e. no stent placed or insufficient draining stent) or persistent biliary dilatation in the future liver remnant on imaging (i.e. previous stent placed in contralateral side of the liver).
Exclusion criteria
Exclusion criteria: - Incompletely recovered from any side effects of previous biliary drainage procedures. Patients are required to be off antibiotic treatment for at least 5 days. - Any contra-indication for major liver surgery (e.g. ECOG/WHO score 3 or higher). - Technical contra-indications for endobiliary drainage (e.g. previous gastrojejunostomy). - Refusal to provide informed consent. - Requirement of multiple stents for adequate drainage of the future liver remnant (e.g. involvement of segmental bile ducts). - In case it is not feasible to prevent blockage of one or more large segmental branches.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of severe drainage related complications between inclusion and exploratory laparotomy. Severe complications are defined as any complication leading to additional invasive interventions, (extended) hospitalization, or death. 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 |
|---|---|
| - The separate incidence of preoperative cholangitis. - The number of drainage procedures required to achieve technical success. - The proportion of patients with therapeutic success. - The total number of drainage procedures that involved (attempted) stent (re-)placement. - Interval bilirubin decrease at 7 days and 14 days after biliary drainage relative to the bilirubin level at inclusion. - The number of patients with rescheduled or cancelled laparotomy due to severe drainage-related complications. - Quality of life. - Postoperative morbidity and mortality, among patients who underwent combined extrahepatic bile duct and liver resection. | — |
Contacts
Public ContactJeska Fritzsche
Amsterdam UMC
Outcome results
None listed