Trial document




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  DRKS00011918

Trial Description

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Title

Safety and Efficacy of Laser-assisted Surgery for Pulmonary Metastasectomy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This is a prospective, non-interventional, bicentric study assessing the safety and efficacy of laser-assisted pulmonary metastasectomy in different tumor types. Pulmonary metastasectomy has been shown to be associated with a survival benefit in different tumor types. Metastases can be resected using different techniques including staplers, cautery devices, Ligasure/Ultracision-System as well as Nd:YAG-Lasers. The latter has been shown to facilitate the complete resection of a significantly higher number of metastases, while achieving similar long-term survival rates. Possible advantages of laser resection have been shown in a variety of retrospective studies. However, data on the exact mechanisms on why laser-assisted metastasectomy is beneficial is scarce. In our study we would like to address the issue of safety and efficacy of laser resection using a 1.320 nm diode-pumped Nd:YAG-Laser (Limax® 120, Gebrüder Martin GmbH & Co. KG, Tuttlingen/Germany) in a prospective manner.
We will include a total of 40 patients with pulmonary metastastes from solid tumors in whom a laser-assisted pulmonary metastasectomy is performed at the participating centers (Department of Thoracic Surgery, University Medical Center Freiburg and SLK Lung Clinic Löwenstein). Safety and efficacy of laser assisted pulmonary metastasectomy will be evaluated by assessing predefined intraoperative and postoperative parameters as well as morbidity and mortality.

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Brief Summary in Scientific Language

Pulmonary metastasectomy is associated with a survival benefit in selected patients. It can be carried using different surgical techniques including staplers, cautery devices, Ligasure/Ultracision-System as well as Nd:YAG-Lasers . The latter has been shown to facilitate the complete resection of a significantly higher number of metastases compared with conventional resection while achieving similar long-term survival rates. Laser resection is thought to provide better sealing of the lung tissues and coagulation of the intrapulmonary vessels and thus has been associated with a shorter air leakage and hospital stay. Also, operation times have been shown to be reduced by using the laser device. The resection can be carried out with high precision causing only minimal deformity to the adjacent lung tissue and enabling the oncologic surgeon to preserve as much healthy lung tissue as possible and thus preserving the possibility of repeated resections.
Hence, laser-devices may expand the indications for surgical treatment of pulmonary metastases. However, data on the exact mechanisms on why laser-assisted metastasectomy is beneficial is scarce. In our study we would like to address the issue of safety and efficacy of laser resection using a 1320 nm Nd:YAG-Laser in a prospective manner.

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Organizational Data

  •   DRKS00011918
  •   2017/11/15
  •   [---]*
  •   yes
  •   Approved
  •   289/17, 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

  •   Safety of laser resection will be assessed during and at the end of the hospital stay by collecting the following parameters: Intraoperative blood loss, duration of surgery, placed chest tubes, used energy and postoperative parameters including drainage time, total pleural-effusion, duration of air leakage, as well as postoperative complications, such as pneumonia, bleeding or persistent pneumothorax. Further parameters will be assessed as needed from patient charts.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

- Completeness of resection

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Secondary Outcome

- Length of hospital stay
- Intraoperative parameters including blood loss, duration of surgery, used energy
- Postoperative parameters including drainage time, total pleural-effusion, duration of air leakage
- Postoperative complications including pneumonia and bleeding
- Postoperative mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/10/18
  •   40
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Resectable pulmonary metastases according to current oncologic and clinical principles
- Planned pulmonary metastasectomy
- Informed consent prior to the procedure
- Age ≥ 18 years

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Exclusion Criteria

Age < 18 years

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Addresses

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    • UNIVERSITÄTSKLINIKUM FREIBURG Department Chirurgie Klinik für Thoraxchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    •   [---]*
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    • UNIVERSITÄTSKLINIKUM FREIBURGDepartment ChirurgieKlinik für Thoraxchirurgie
    • Mr.  Dr.  Severin  Schmid 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • UNIVERSITÄTSKLINIKUM FREIBURGDepartment ChirurgieKlinik für Thoraxchirurgie
    • Mr.  Dr.  Severin  Schmid 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • UNIVERSITÄTSKLINIKUM FREIBURG Department Chirurgie Klinik für Thoraxchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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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.