A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer

Not Applicable

• Conditions: Non-small Cell Lung Cancer
• Interventions: Procedure: axillary thoracotomy; Procedure: video-assisted thoracoscopic surgery

• Registration Number: NCT01102517
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The purpose of this study is to establish the effects of VATS lobectomy for early-stage non-small cell lung cancer.

The aims of this study are:

1. To evaluate the early clinical benefits of VATS lobectomy when compared with the axillary thoracotomy.

2. To evaluate the late effects of VATS lobectomy on survival and quality of life when compared with axillary thoracotomy.

3. To establish the normative pattern of VATS lobectomy for early-stage non-small cell lung cancer.

4. To explore the indication of VATS lobectomy for the lung cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Early stage NSCLC and no metastasis of hilum of lung and mediastinum lymph nodes (short diameter ≤ 1 cm) on computed tomography (CT) scan;
• No medical contraindications to lung resection
• Age ≤ 75 years old and ≥18 years old;
• Sign the informed consent form.

Exclusion Criteria

• Evidence of invasion into neighboring organs;
• Extensive pleura adhesion;
• Central lesion;
• Not suitable for single-lung ventilation;
• Had history of thoracotomy and radiation for thoracic region ;
• Pregnancy or lactation female patients;
• Cannot sign the informed consent form because of psychological, family and society factors;
• Had history of other malignant tumors within 5 years except for non-melanoma cutaneous cancer, uterine cervix cancer in situ and curative early-stage carcinoma of prostate;
• Participants can not accept operation for other uncontrolled factors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
axillary thoracotomy	axillary thoracotomy	Control group
VATS group	video-assisted thoracoscopic surgery	video-assisted thoracoscopic surgery

Primary Outcome Measures

Name	Time	Method
Disease-free survival and overall survival	5 years

Secondary Outcome Measures

Name	Time	Method
Perioperation data	perioperation	operation time, intraoperative blood loss, chest tube drainage amount, duration of the chest tube placement, and duratio
Cytokines response	the first 48 hours after the surgery	IL-2,IL-4,IL-6,IL-10,TNF,IFN-r
Quality of life	the first year after the surgery	Lung Cancer Symptom Scale
Postoperative pulmonary function	the first three months after the surgery
Postoperative Karnofsky performance status	the first year after the surgery
Postoperative Chest Pain	the first year after the surgery	visual analogue scale and Wong-Baker FACES Pain Rating Scale

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 GuangZhou, Guangdong, China