NL-OMON52313RecruitingNot Applicable
Endobiliary radiofrequency ablation for malignant biliary obstruction due to perihilar cholangiocarcinoma: a randomized controlled trial - RACCOO
Amsterdam UMC0 sites73 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 73
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
Investigators
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