NL-OMON52313
Recruiting
Not Applicable
Endobiliary radiofrequency ablation for malignant biliary obstruction due to perihilar cholangiocarcinoma: a randomized controlled trial - RACCOO
Amsterdam UMC0 sites73 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Amsterdam UMC
- Enrollment
- 73
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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