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OpenTrials
Completed

NCT Number: NCT03613467

Is Video-assisted Thoracoscopic Lobectomy a Clinical Alternative for Surgically Resectable Pathologic N2 NSCLC Patients

The study was designed to compare the safety and effectiveness of vedio-assisted thoracoscopic lobectomy with open lobectomy for patients with surgically resectable pathologic N2 non-small cell lung cancer

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China PLA General Hospital, Beijing, Beijing Municipality, China

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About this study

The is a multi-center retrospective study. Patients with pathologic N2 NSCLC who underwent VATS or open lobectomy between 2014 and 2017 were included into this study. Clinical data on patient demographic, clinical characteristics, treatment and clinical outcomes will be collected to evaluate the safety and effectiveness of video-assisted thoracoscopic lobectomy for pathologic N2 NSCLC.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with age > 18 years old;
  • Patients with pathologically diagnosed non-small cell lung cancer;
  • Patients underwent lobectomy by either VATS or thoracotomy between 2014 and 2017;
  • Patients who received lymphadenectomy for all accessible lymph nodes;
  • Patients with N2 lymph nodes (+) after surgeries;

Exclusion criteria

  • Patients with second primary tumors or multiple primary tumors;
  • Patients who received chest surgeries before hospitalization;
  • Patients with superior pulmonary sulcus tumor

Treatment and study plan

VATS lobectomy

Procedure

Patients who received lobectomy by video-assisted thoracoscopic surgery

Thoracotomy lobectomy

Procedure

Patients who received lobectomy by thoracotomy

Primary outcomes

  1. Overall survival

    Time frame: 2014-2018

    Overall survival

Secondary outcomes

  1. Duration of hospital stay [Perioperative outcomes]

    Time frame: 2014-2017

    Duration of hospital stay [Perioperative outcomes]

  2. Postoperative 30 and 90 days [Perioperative outcomes]

    Time frame: 2014-2017

    Postoperative 30 and 90 days [Perioperative outcomes]

  3. Drainage time [Perioperative outcomes]

    Time frame: 2014-2017

    Drainage time [Perioperative outcomes]

  4. Intraoperative blood loss [Perioperative outcomes]

    Time frame: 2014-2017

    Intraoperative blood loss [Perioperative outcomes]

  5. Postoperative complications [Perioperative outcomes]

    Time frame: 2014-2017

    Postoperative complications [Perioperative outcomes]

Other outcomes

  1. Overall survivals in the subgroups stratified by T staging

    Time frame: 2014-2018

    Overall survivals in the subgroups stratified by T staging

  2. Overall survivals in the subgroups stratified by neoadjuvant therapy

    Time frame: 2014-2018

    Overall survivals in the subgroups stratified by neoadjuvant therapy

  3. Overall survivals in the subgroups stratified by number of lymph node station involved

    Time frame: 2014-2018

    Overall survivals in the subgroups stratified by number of lymph node station involved

  4. Impact factors for overall survival

    Time frame: 2014-2018

    Impact factors for overall survival

  5. Impact factors for postoperative mortality within 30/90 days

    Time frame: 2014-2017

    Impact factors for postoperative mortality within 30/90 days

  6. Propensity score matching analysis of overall survival

    Time frame: 2014-2018

    Propensity score matching analysis of overall survival

  7. Propensity score matching analysis of perioperative outcomes

    Time frame: 2014-2018

    Propensity score matching analysis of perioperative outcomes

  8. Propensity score matching analysis of impact factors for overall survival

    Time frame: 2014-2018

    Propensity score matching analysis of impact factors for overall survival

  9. Propensity score matching analysis of impact factors for postoperative mortality within 30/90 days

    Time frame: 2014-2018

    Propensity score matching analysis of impact factors for postoperative mortality within 30/90 days

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Collaborators

  • LinkDoc Technology (Beijing) Co. Ltd.

Registry information

Official study title

Vedio-assisted Thoracoscopic Lobectomy vs Open Lobectomy for Patients With Surgically Resectable Pathologic N2 NSCLC

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2018
Registry last updated
Aug 9, 2018

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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