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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613467
• Other study ID #: W-TONG06
• Status: Completed
• Start date: July 4, 2018
• Est. completion date: July 6, 2018

Study information

• Verified date: August 2018
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2145
• Est. completion date: July 6, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Procedure:
• VATS lobectomy
Patients who received lobectomy by video-assisted thoracoscopic surgery
• Thoracotomy lobectomy
Patients who received lobectomy by thoracotomy

Locations

Country	Name	City	State
China	China PLA General Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Huaxi Hospital Affiliated to Sichuan University	Chengdu	Sichuan
China	First Hospital Affiliated to Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu cancer hospital	Nanjing	Jiangsu
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	Tongji Hospital Affiliated to Huazhong Technology Hospital	Wuhan	Hubei
China	Xi'an Tangdu Hospital	Xi'an	Shaanxi
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Tang-Du Hospital	LinkDoc Technology (Beijing) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survivals in the subgroups stratified by T staging	Overall survivals in the subgroups stratified by T staging	2014-2018
Other	Overall survivals in the subgroups stratified by neoadjuvant therapy	Overall survivals in the subgroups stratified by neoadjuvant therapy	2014-2018
Other	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
Other	Impact factors for overall survival	Impact factors for overall survival	2014-2018
Other	Impact factors for postoperative mortality within 30/90 days	Impact factors for postoperative mortality within 30/90 days	2014-2017
Other	Propensity score matching analysis of overall survival	Propensity score matching analysis of overall survival	2014-2018
Other	Propensity score matching analysis of perioperative outcomes	Propensity score matching analysis of perioperative outcomes	2014-2018
Other	Propensity score matching analysis of impact factors for overall survival	Propensity score matching analysis of impact factors for overall survival	2014-2018
Other	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
Primary	Overall survival	Overall survival	2014-2018
Secondary	Duration of hospital stay [Perioperative outcomes]	Duration of hospital stay [Perioperative outcomes]	2014-2017
Secondary	Postoperative 30 and 90 days [Perioperative outcomes]	Postoperative 30 and 90 days [Perioperative outcomes]	2014-2017
Secondary	Drainage time [Perioperative outcomes]	Drainage time [Perioperative outcomes]	2014-2017
Secondary	Intraoperative blood loss [Perioperative outcomes]	Intraoperative blood loss [Perioperative outcomes]	2014-2017
Secondary	Postoperative complications [Perioperative outcomes]	Postoperative complications [Perioperative outcomes]	2014-2017