Endobiliary radiofrequency ablation for malignant biliary obstruction due to perihilar cholangiocarcinoma: a randomized controlled trial

Recruiting

Conditions: bile duct cancer
Cholangiocarcinoma
10019815

Registration Number: NL-OMON52313

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 73

Inclusion Criteria

- 18 years or older.
- Capable of providing written and oral informed consent.
- Histological or cytological proof of perihilar cholangiocarcinoma
(adenocarcinoma).
- Perihilar biliary obstruction with 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the time to biliary obstruction.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include technical and functional success, the effect on<br /><br>quality of life, overall survival, adverse events, number of re-interventions,<br /><br>time to re-interventions, need for external drains, and evaluation of the<br /><br>effect of repeated eRFA on stent patency. </p><br>