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

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Procedure: VATS lobectomy; Procedure: Thoracotomy lobectomy

• Registration Number: NCT03613467
• Lead Sponsor: Tang-Du Hospital

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.

Study Timeline

• Study Start: 2018-07-04
• Primary Completion: 2018-07-04
• Study Completion: 2018-07-06
• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-27
• Status Verified: 2018-08
• Study First Posted: 2018-08-03
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2145

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VATS lobectomy	VATS lobectomy	Pathologic N2 NSCLC patients who received lobectomy by video-assisted thoracoscopic surgery
Thoracotomy lobectomy	Thoracotomy lobectomy	Pathologic N2 NSCLC patients who received lobectomy by thoracotomy

Primary Outcome Measures

Name	Time	Method
Overall survival	2014-2018	Overall survival

Secondary Outcome Measures

Name	Time	Method
Postoperative 30 and 90 days [Perioperative outcomes]	2014-2017	Postoperative 30 and 90 days \[Perioperative outcomes\]
Drainage time [Perioperative outcomes]	2014-2017	Drainage time \[Perioperative outcomes\]
Duration of hospital stay [Perioperative outcomes]	2014-2017	Duration of hospital stay \[Perioperative outcomes\]
Postoperative complications [Perioperative outcomes]	2014-2017	Postoperative complications \[Perioperative outcomes\]
Intraoperative blood loss [Perioperative outcomes]	2014-2017	Intraoperative blood loss \[Perioperative outcomes\]

Trial Locations

Locations (10)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

China PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Tongji Hospital Affiliated to Huazhong Technology Hospital; 🇨🇳 Wuhan, Hubei, China

Jiangsu cancer hospital; 🇨🇳 Nanjing, Jiangsu, China

Xi'an Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

Huaxi Hospital Affiliated to Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Tianjin Chest Hospital; 🇨🇳 Tianjin, Tianjin, China

First Hospital Affiliated to Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China