Endobiliary radiofrequency ablation for malignant biliary obstruction due to perihilar cholangiocarcinoma: a pilot study (RACCOON-pilot)

Completed

Conditions: cancer of the bile ducts in the liver
cholangiocarcinoma
10019815

Registration Number: NL-OMON55062

Lead Sponsor: Maag-, darm-, en leverziekten

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Patients with symptomatic biliary obstruction due to unresectable perihilar
cholangiocarcinoma (CCA)

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary aim of the proposed pilot study is to evaluate whether eRFA is<br /><br>feasible, safe in patients with unresectable perihilar cholangiocarcinoma.<br /><br><br /><br>- Technical success of initial ablation.<br /><br>- Technical success of stent placement, defined as successful deployment of the<br /><br>stent in the intended location with sufficient coverage of the stricture.<br /><br>- Functional success defined as 50% decrease or normalization of bilirubin<br /><br>level within 14 days of the procedure or relieve of symptoms in case of<br /><br>cholangitis.<br /><br>- The occurrence of (severe) adverse events</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Time to biliary obstruction, defined as period between initial procedure and<br /><br>recurrence of biliary obstruction. Recurrence of biliary obstruction is defined<br /><br>as recurrent jaundice or cholangitis(40).<br /><br>- Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate<br /><br>biliary drainage.<br /><br>- Time to re-intervention.<br /><br>- Stent patency after repeated eRFA.<br /><br>- Quality of life.<br /><br>- Overall survival.</p><br>