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

Sun Yat-sen University logo

Sun Yat-sen University

Status

Unknown

Conditions

Non-small Cell Lung Cancer

Treatments

Procedure: video-assisted thoracoscopic surgery
Procedure: axillary thoracotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01102517
2007039

Details and patient eligibility

About

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.

Enrollment

500 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

500 participants in 2 patient groups

VATS group
Experimental group
Description:
video-assisted thoracoscopic surgery
Treatment:
Procedure: video-assisted thoracoscopic surgery
axillary thoracotomy
Other group
Description:
Control group
Treatment:
Procedure: axillary thoracotomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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