Endobiliairy radiofrequency ablation for malignant biliairy obstruction, RACCOON-pilot

Recruiting

• Conditions: Parihilair cholangiocarcinoma

• Registration Number: NL-OMON27848
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

18 years or older.
-Capable of providing written and oral informed consent.
-Histological or cytological proof of perihilar CCA (adenocarcinoma)*
-Biliary obstruction with indication for drainage (symptomatic (itch or cholangitis) or necessary for systemic therapy).
-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).

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.
-Implantable pacemaker and implantable cardioverter/ defibrillator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim of the proposed pilot study is to evaluate whether eRFA is feasible, safe in patients with unresectable perihilar cholangiocarcinoma.

Secondary Outcome Measures

Name	Time	Method
Recurrence of biliary obstruction, quality of life