Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial

A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.

Inclusion Criteria:

• 18 years or older.

• Capable of providing written and oral informed consent.

• Histological or cytological proof of perihilar CCA (adenocarcinoma).

• Perihilar biliary obstruction with an 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:

• 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.