Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma (RACCOON)

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

Status

Enrolling

Conditions

Perihilar Cholangiocarcinoma

Treatments

Device: Endobiliary radiofrequency ablation (eRFA)

Device: uncovered self-expanding metal stent (uSEMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT05546372

NL76591.029.22

Details and patient eligibility

About

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.

Enrollment

98 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.