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NCT Number: NCT05546372

Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma

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.

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Key information

Conditions

Perihilar Cholangiocarcinoma Adenocarcinoma Carcinoma Cholangiocarcinoma Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC location VUmc

Amsterdam, 1081HV, Netherlands

Location status: Recruiting

Location contact

Esmée Smit, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endobiliary radiofrequency ablation (eRFA)

Device

Intraductal radiofrequency ablation of tumor prior to stent placement

uncovered self-expanding metal stent (uSEMS)

Device

Intraductal placement of uncovered metal stent

Primary outcomes

  1. Time to biliary obstruction

    Time frame: Through study completion, max 1 year

    Defined as period between initial procedure and recurrence of biliary obstruction. Recurrence of biliary obstruction is defined as recurrent jaundice (conjugated bilirubin ≥ 40 umol/l (≥2.3 mg/dl)), presence of biochemical evidence of cholestasis along with dilatation of the drained bile duct(s), or endoscopic findings suggesting stent occlusion.

Secondary outcomes

  1. Quality of life expressed in quality adjusted life-years (QALYs)

    Time frame: Through study completion, max 1 year

    EORTC QLQ-C30, BIL21 and EQ-5D questionnaires are to be filled out 4 weeks and every3 months after the intervention

  2. Number of patients with technical success of initial ablation

    Time frame: During intervention

    Defined as completion of ablation of the malignant stenosis through which the stent will be placed using RFA for 120 seconds with 7W.

  3. Number of patients with functional success

    Time frame: 14 days

    In case of inadequate drainage prior to the procedure (bilirubin ≥40 umol/L [≥2.3 mg/dl]), defined as 50% decrease or normalization of bilirubin level within 14 days of the procedure or relieve of symptoms in case of cholangitis. In case of sufficient drainage prior to the procedure, a persistent bilirubin level <40 umol/L (<2.3 mg/dl) after 14 days is considered functional success.

  4. Presumed reason of recurrent biliary obstruction

    Time frame: Through study completion, an average of 1 year

    • Stent occlusion due to tumour ingrowth
    • Stent occlusion due to tumour overgrowth
    • Stent occlusion due to sludge with/or without stones, hemobilia, food impaction
    • Stent migration

  5. Need for unscheduled re-intervention (PTC and/or ERCP) to achieve adequate biliary drainage.

    Time frame: Through study completion, an average of 1 year

  6. Need for external drainage catheters.

    Time frame: Through study completion, an average of 1 year

  7. Time to re-intervention.

    Time frame: Through study completion, an average of 1 year

  8. Stent patency after repeated eRFA.

    Time frame: Through study completion, an average of 1 year

  9. Adverse events within 30 days after the procedu

    Time frame: 30 days

  10. Overall survival.

    Time frame: Through study completion

  11. Healthcare costs.

    Time frame: Through study completion, max 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Esmée Smit

CONTACT

[email protected]

+31204440613

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Clinical Hospital Colentina
  • Erasmus Medical Center
  • Leiden University Medical Center
  • Maastricht University Medical Center
  • Medisch Spectrum Twente
  • Orlando Health, Inc.
  • St. Antonius Hospital
  • UMC Utrecht
  • Universitaire Ziekenhuizen KU Leuven
  • University Hospital Prague (IKEM), Prague, Czech Republic
  • University Hospital, Ghent
  • University Medical Center Groningen

Registry information

Official study title

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

Acronym: RACCOON

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2022
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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