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Clinical Trials/NL-OMON52313
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

Sponsor
Amsterdam UMC

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