Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

Summary

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.

Eligibility

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.

Conditions2

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