RecruitingNot ApplicableNCT05546372

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

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

98 participants

Start Date

Nov 9, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria8

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.