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Recruiting NCT05546372

Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

No phase Interventional Perihilar Cholangiocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endobiliary radiofrequency ablation (eRFA), uncovered self-expanding metal stent (uSEMS).
Who it may be relevant to
Registry conditions: Perihilar Cholangiocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial

Overview

A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.

Interventions

  • Device Endobiliary radiofrequency ablation (eRFA)
    Intraductal radiofrequency ablation of tumor prior to stent placement
  • Device uncovered self-expanding metal stent (uSEMS)
    Intraductal placement of uncovered metal stent

Primary outcome measures

  • Time to biliary obstruction [Time frame: Through study completion, max 1 year]
Secondary outcome measures (11)
  • Quality of life expressed in quality adjusted life-years (QALYs) [Time frame: Through study completion, max 1 year]
  • Number of patients with technical success of initial ablation [Time frame: During intervention]
  • Number of patients with functional success [Time frame: 14 days]
  • Presumed reason of recurrent biliary obstruction [Time frame: Through study completion, an average of 1 year]
  • Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage. [Time frame: Through study completion, an average of 1 year]
  • Need for external drainage catheters. [Time frame: Through study completion, an average of 1 year]
  • Time to re-intervention. [Time frame: Through study completion, an average of 1 year]
  • Stent patency after repeated eRFA. [Time frame: Through study completion, an average of 1 year]
  • Adverse events within 30 days after the procedu [Time frame: 30 days]
  • Overall survival. [Time frame: Through study completion]
  • Healthcare costs. [Time frame: Through study completion, max 1 year]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Netherlands · 1 center
  • Amsterdam UMC location VUmc — Amsterdam

Identifiers

NCT: NCT05546372 · NL76591.029.22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗