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Endoluminal Radiofrequency Ablation for the Treatment of Malignant Biliary Stenosis

NCT04801719 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2021-03-17

No results posted yet for this study

Summary

The rationale of the study is to explore the safety and efficacy of endoluminal radiofrequency ablation prior metal stent insertion in patiens with malignant biliary stenosis.

Conditions

  • Radiofrequency Ablation
  • Biliary Tract Cancer
  • Stent Complication
  • Brachytherapy

Interventions

DEVICE

Habib™ EndoHPB; Boston Scientific, US; former EMcision Ltd., UK

Randomised patients in selected arm received endoluminal RFA by 8F catheter (Habib™ EndoHPB; Boston Scientific, US; former EMcision Ltd., UK) before stenting procedure. Repeated ablations were processed through stenotic areas of bile ducts (10W, 90-120s, Rita 1500, Angiodynamics Ltd), all drained biliary tracts were used for introducing catheter and performance of ablation. Ablation procedure was followed with uncovered self-expandable metal stent insertion.

Sponsors & Collaborators

  • Brno University Hospital

    lead OTHER

Principal Investigators

  • Tomáš Andrašina, MD · Brno University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-04
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04801719 on ClinicalTrials.gov