Trial document





This trial has been registered retrospectively.
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  DRKS00004427

Trial Description

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Title

Prospective study to evaluate video-assisted thoracoscopy surgery (VATS) vs. thoracotomy for lobe resection of clinical stage I Non-Small Cell Lung Cancer

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Trial Acronym

VATS-Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients suffering from a on-small-cell lung cancer (NSCLC) in stage I will be included in this trial.
The video-assisted thoracoscopic lung lobe resection will be compared with the open thoracic surgery of the lung lobe, in consideration of mortality, hospital admission rate and economic factors.

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Brief Summary in Scientific Language

Evaluation of video-assisted thoracoscopic lung lobe resection compared to lobectomy following thoracotomy in patients with peripheral stage I NSCLC considering the morbidity, hospital admission rate and economic aspects.

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Organizational Data

  •   DRKS00004427
  •   2012/10/11
  •   [---]*
  •   yes
  •   Approved
  •   380/08, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   VATS lobectomy with 3 incisions without rib spreaders with lymph node dissection
  •   Anterolateral thoracotomy with lymph node dissection
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

- Local recurrence rate and 5-year survival rate
- Quality of Life (EORTC-C30 for lung cancer)
- Hospitalization costs

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Secondary Outcome

- Need for pain medication
- Duration of hospital admission
- Number of resected lymph nodes
- Postoperative FEV1, TLCO

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/01/16
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Preoperative peripheral stage 1 NSCLC in stage
- CT of thorax
- PET

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Exclusion Criteria

- cT3
- N2 +
- Central tumors
- Tumor visible in bronchoscopy
- Tumor diameter > 5cm

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg - Abteilung für Thoraxchirurgie
    • Mr.  Dr. med.  Emanuel  Palade 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg - Abteilung für Thoraxchirurgie
    • Mr.  Dr. med.  Emanuel  Palade 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg - Abteilung für Thoraxchirurgie
    • Mr.  Prof. Dr. med.  Bernward  Passlick 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/12/31
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.