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VATS Surgery Compared to Drainage in the Treatment of Pleural Empyema

Study acronym: FIVERVATS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Site details revised at 1 of 3 sitesv13
  2. Notable Primary completion date: Mar 1, 2026 to Oct 30, 2027
    • Study completion date: Mar 1, 2027 to Oct 30, 2028
    v12
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Oct 1, 2022 to Oct 30, 2022
    v11
  4. Notable Start date: Sep 1, 2022 to Oct 1, 2022
    • Primary completion date: Feb 1, 2026 to Mar 1, 2026
    • Study completion date: Feb 1, 2027 to Mar 1, 2027
    v10
  5. Notable Start date: Jun 1, 2022 to Sep 1, 2022
    • Primary completion date: Nov 1, 2025 to Feb 1, 2026
    • Study completion date: Nov 1, 2026 to Feb 1, 2027
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Notable Start date: Apr 1, 2022 to Jun 1, 2022
    • Primary completion date: Sep 1, 2025 to Nov 1, 2025
    • Study completion date: Sep 1, 2026 to Nov 1, 2026
    v8
  2. Notable Start date: Mar 1, 2022 to Apr 1, 2022
    • Primary completion date: Aug 1, 2025 to Sep 1, 2025
    • Study completion date: Aug 1, 2026 to Sep 1, 2026
    v7
  3. Notable Start date: Jan 1, 2022 to Mar 1, 2022
    • Primary completion date: Jun 1, 2025 to Aug 1, 2025
    • Study completion date: Jun 1, 2026 to Aug 1, 2026
    v6
  4. Notable Start date: Nov 1, 2021 to Jan 1, 2022
    • Primary completion date: Apr 1, 2025 to Jun 1, 2025
    • Study completion date: Apr 1, 2026 to Jun 1, 2026
    v5
  5. Minor Eligibility criteria expanded, about 210 words
    • Study description expanded, about 376 words
    v4
  6. Notable Primary completion date: Mar 1, 2023 to Apr 1, 2025v3 Show 5 more changesShow less
    • Start date: Sep 1, 2020 to Nov 1, 2021
    • Primary endpoint revised
    • Study completion date: Mar 1, 2024 to Apr 1, 2026
    • Secondary endpoints: 15 to 12
    • Study description expanded, about 127 words
  7. Notable Primary completion date: Sep 1, 2022 to Mar 1, 2023
    • Start date: Mar 1, 2020 to Sep 1, 2020
    • Study completion date: Sep 1, 2023 to Mar 1, 2024
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pleura empyema is a frequent disease with a high morbidity and a mortality rate of approximately 15%. Pleura empyema is characterized by the passage of three stages (I - III). The aim of treating the disease is to remove the infection and provide fully expansion of the lung. The initial treatment at the early stage of the disease (stage I) is simple drainage. In clinical practice, stages II and III are treated alike. Current standard treatment for these stages is drainage with ultrasound (ULS) -guided pigtail. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of Video Assisted Thoracoscopic Surgery (VATS). The theoretical advantage of early surgery is that patients undergo rapid, definitive treatment. Furthermore, surgery can ensure optimal drain placement. How best to treat these patients (drainage or surgery) is still under clinical evaluation and depends to a great extent on local clinical practice. It is only to a limited extent based on scientific evidence. The aim of this study is to determine if there is a difference in outcome in patients diagnosed with stage II and stage III empyema who either receive primary VATS surgery or ULS guided drainage and intrapleural therapy (fibrinolytic (altaplasm) with DNase (Pulmozyne ®)) The primary outcome is Hospitalization time and secondary outcomes is e.g. mortality, health related costs and quality of life. The present study can thus provide new and highly relevant knowledge as well as change the treatment of these patients, both nationally and internationally. It is planned that a total of 184 patients will be included in the project. The study takes place as a collaboration between all four thoracic surgical departments and the major pulmonary medicine departments in Denmark. In addition, the study has international collaborators/consultants who will provide counselling in connection with the study.
Trial Details
NCT Number NCT04095676
Lead Sponsor Thomas Decker Christensen
Collaborators: Odense University Hospital, Rigshospitalet, Denmark, Aalborg University Hospital
Conditions
(from sponsor)
Pleural Empyema
Related terms Empyema, Pleural
Enrollment 184 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov