Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC, Clinical, Early-stage
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.
Interventions
PROCEDUREvideo-assisted thoracoscopic surgery
video-assisted thoracoscopic surgery
PROCEDUREaxillary thoracotomy
axillary thoracotomy lobectomy
Sponsors
Shanghai Chest Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Shenzhen People's Hospital
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival and overall survival | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pulmonary function | the first three months after the surgery | — |
| Postoperative Karnofsky performance status | the first year after the surgery | — |
| Quality of life | the first year after the surgery | Lung Cancer Symptom Scale |
| 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 |
| Postoperative Chest Pain | the first year after the surgery | visual analogue scale and Wong-Baker FACES Pain Rating Scale |
Countries
China
Outcome results
None listed