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

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

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

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Procedure: VATS lobectomy; Procedure: Thoracotomy lobectomy

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.

• Study Type: Observational
• Enrollment (Actual): 2145

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
    • Beijing, Beijing, China, 100853
      • China PLA General Hospital
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Huazhong Technology Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710000
      • Xi'an Tangdu Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Huaxi Hospital Affiliated to Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300051
      • Tianjin Chest Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • First Hospital Affiliated to Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VATS lobectomy; Pathologic N2 NSCLC patients who received lobectomy by video-assisted thoracoscopic surgery	Procedure: VATS lobectomy; Patients who received lobectomy by video-assisted thoracoscopic surgery
Thoracotomy lobectomy; Pathologic N2 NSCLC patients who received lobectomy by thoracotomy	Procedure: Thoracotomy lobectomy; Patients who received lobectomy by thoracotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	2014-2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospital stay [Perioperative outcomes]	Duration of hospital stay [Perioperative outcomes]	2014-2017
Postoperative 30 and 90 days [Perioperative outcomes]	Postoperative 30 and 90 days [Perioperative outcomes]	2014-2017
Drainage time [Perioperative outcomes]	Drainage time [Perioperative outcomes]	2014-2017
Intraoperative blood loss [Perioperative outcomes]	Intraoperative blood loss [Perioperative outcomes]	2014-2017
Postoperative complications [Perioperative outcomes]	Postoperative complications [Perioperative outcomes]	2014-2017

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survivals in the subgroups stratified by T staging	Overall survivals in the subgroups stratified by T staging	2014-2018
Overall survivals in the subgroups stratified by neoadjuvant therapy	Overall survivals in the subgroups stratified by neoadjuvant therapy	2014-2018
Overall survivals in the subgroups stratified by number of lymph node station involved	Overall survivals in the subgroups stratified by number of lymph node station involved	2014-2018
Impact factors for overall survival	Impact factors for overall survival	2014-2018
Impact factors for postoperative mortality within 30/90 days	Impact factors for postoperative mortality within 30/90 days	2014-2017
Propensity score matching analysis of overall survival	Propensity score matching analysis of overall survival	2014-2018
Propensity score matching analysis of perioperative outcomes	Propensity score matching analysis of perioperative outcomes	2014-2018
Propensity score matching analysis of impact factors for overall survival	Propensity score matching analysis of impact factors for overall survival	2014-2018
Propensity score matching analysis of impact factors for postoperative mortality within 30/90 days	Propensity score matching analysis of impact factors for postoperative mortality within 30/90 days	2014-2018

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Collaborators: LinkDoc Technology (Beijing) Co. Ltd.
• Investigators: Principal Investigator: Xiaofei Li, PhD, Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2018
• Primary Completion (Actual): July 4, 2018
• Study Completion (Actual): July 6, 2018

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Vedio-assisted thoracoscopic lobectomy; Thoracotomy lobectomy; Real-world evidences;; pN2 NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: W-TONG06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No