Clinical trial NCT03613467: Is Video-assisted Thoracoscopic Lobectomy a Clinical Alternative for Surgically Resectable Pathologic N2 NSCLC Patients
Official title: Vedio-assisted Thoracoscopic Lobectomy vs Open Lobectomy for Patients With Surgically Resectable Pathologic N2 NSCLC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Vedio-assisted thoracoscopic lobectomy
Thoracotomy lobectomy
Real-world evidences;
pN2 NSCLC
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2018-08-03
Enrollment: 2145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pathologically diagnosed N2 non-small cell lung cancer who received VATS or thoracotomy lobectomy between 2014 and 2017

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 2014-2018
Secondary outcomes:
measure: Duration of hospital stay [Perioperative outcomes]
timeFrame: 2014-2017
measure: Postoperative 30 and 90 days [Perioperative outcomes]
timeFrame: 2014-2017
measure: Drainage time [Perioperative outcomes]
timeFrame: 2014-2017
measure: Intraoperative blood loss [Perioperative outcomes]
timeFrame: 2014-2017
measure: Postoperative complications [Perioperative outcomes]
timeFrame: 2014-2017
Other outcomes:
measure: Overall survivals in the subgroups stratified by T staging
timeFrame: 2014-2018
measure: Overall survivals in the subgroups stratified by neoadjuvant therapy
timeFrame: 2014-2018
measure: Overall survivals in the subgroups stratified by number of lymph node station involved
timeFrame: 2014-2018
measure: Impact factors for overall survival
timeFrame: 2014-2018
measure: Impact factors for postoperative mortality within 30/90 days
timeFrame: 2014-2017
measure: Propensity score matching analysis of overall survival
timeFrame: 2014-2018
measure: Propensity score matching analysis of perioperative outcomes
timeFrame: 2014-2018
measure: Propensity score matching analysis of impact factors for overall survival
timeFrame: 2014-2018
measure: Propensity score matching analysis of impact factors for postoperative mortality within 30/90 days
timeFrame: 2014-2018
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: China PLA General Hospital
state: Beijing
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Huazhong Technology Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu cancer hospital
state: Jiangsu
city: Xi'an
country: China
facility: Xi'an Tangdu Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Chengdu
country: China
facility: Huaxi Hospital Affiliated to Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Hangzhou
country: China
facility: First Hospital Affiliated to Zhejiang University
state: Zhejiang
Study officials:
affiliation: Tang-Du Hospital
name: Xiaofei Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: