bile duct cancer, Cholangiocarcinoma Bile duct cancer
Conditions
Interventions
eRFA prior to placement of an uncovered self-expanding metal stent (or plastic
stent in case not feasible) compared with stent placement only.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 years or older. - Capable of providing written and oral informed consent. - Histological or cytological proof of perihilar cholangiocarcinoma (adenocarcinoma). - Perihilar biliary obstruction with indication for drainage with uSEMS.* - Advanced (no candidate for surgical resection) due to metastases, vascular or lymph node (N2). involvement on imaging or during staging laparoscopy according to multidisciplinary team (MDT). *Only patients with pCCA are eligible however in case of reasonable doubt between intrahepatic CCA with a perihilar biliary obstruction or massforming pCCA, patients can be included.
Exclusion criteria
Exclusion criteria: - Patients who potentially qualify for curative resection of pCCA. - pCCA eligible for liver transplantation. - Life-expectancy less than 3 months. - ERCP and PTC technically not feasible. - Uncontrolled coagulopathy (PTT >1,5x prolonged or thrombocytes below 40*10E9/L). - Ongoing cholangitis or liver abscess. Patients are required to be off antibiotic treatment for cholangitis and/or liver abscess at least 7 days. - Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study. - Patients who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the time to biliary obstruction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include technical and functional success, the effect on quality of life, overall survival, adverse events, number of re-interventions, time to re-interventions, need for external drains, and evaluation of the effect of repeated eRFA on stent patency. | — |
Countries
Belgium, Czech Republic, Netherlands, Romania, United States
Contacts
Public ContactR.P. Voermans
Amsterdam UMC
Outcome results
None listed