cancer of the bile ducts in the liver cholangiocarcinoma
Conditions
Interventions
Endoluminale Radiofrequente Ablatie (eRFA).
Sponsors
Maag-, darm-, en leverziekten
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with symptomatic biliary obstruction due to unresectable perihilar cholangiocarcinoma (CCA)
Exclusion criteria
Exclusion criteria: - Resectable CCA. - Intrahepatic or distal CCA, or gallbladder cancer. - CCA eligible for liver transplantation. - Life-expectancy less than 3 months. - ERCP and PTD technically not feasible. - Uncontrolled coagulopathy (PTT >1,5x prolonged or thrombocytes below 40 10E9/L). - Carcinoma other than adenocarcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of the proposed pilot study is to evaluate whether eRFA is feasible, safe in patients with unresectable perihilar cholangiocarcinoma. - Technical success of initial ablation. - Technical success of stent placement, defined as successful deployment of the stent in the intended location with sufficient coverage of the stricture. - Functional success defined as 50% decrease or normalization of bilirubin level within 14 days of the procedure or relieve of symptoms in case of cholangitis. - The occurrence of (severe) adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time to biliary obstruction, defined as period between initial procedure and recurrence of biliary obstruction. Recurrence of biliary obstruction is defined as recurrent jaundice or cholangitis(40). - Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage. - Time to re-intervention. - Stent patency after repeated eRFA. - Quality of life. - Overall survival. | — |
Countries
Netherlands
Outcome results
None listed