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

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ClinicalTrials.gov Identifier: NCT01102517
Recruitment Status : Active, not recruiting
First Posted : April 13, 2010
Last Update Posted : February 28, 2018
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
Information provided by (Responsible Party):
Hao Long, 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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Procedure: video-assisted thoracoscopic surgery Procedure: axillary thoracotomy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: VATS group
video-assisted thoracoscopic surgery
Procedure: video-assisted thoracoscopic surgery
video-assisted thoracoscopic surgery
axillary thoracotomy
Control group
Procedure: axillary thoracotomy
axillary thoracotomy lobectomy

Primary Outcome Measures :
  1. Disease-free survival and overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: the first year after the surgery ]
    Lung Cancer Symptom Scale

  2. Postoperative pulmonary function [ Time Frame: the first three months after the surgery ]
  3. Postoperative Karnofsky performance status [ Time Frame: the first year after the surgery ]
  4. Postoperative Chest Pain [ Time Frame: the first year after the surgery ]
    visual analogue scale and Wong-Baker FACES Pain Rating Scale

  5. Perioperation data [ Time Frame: perioperation ]
    operation time, intraoperative blood loss, chest tube drainage amount, duration of the chest tube placement, and duratio

  6. Cytokines response [ Time Frame: the first 48 hours after the surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102517

China, Guangdong
Sun Yat-sen University Cancer Center
GuangZhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
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
Principal Investigator: Hao Long, professor Sun Yat-sen University

Additional Information:
1.Bethencourt DM, Holmes EC. Muscle-sparing posterolateral thoracotomy. Ann Thorac Surg. 1988;45(3):337-339. 2.Ginsberg RJ. Alternative (muscle-sparing) incisions in thoracic surgery. Ann Thorac Surg. 1993;56(3):752-754. 3.Weissberg D, Kaufman M. Technical aids in surgery. Two muscle-sparing thoracotomies--techniques and indications. S Afr J Surg. 1990;28(1):17-19. 4.Akçali Y, Demir H, Tezcan B. The effect of standard posterolateral versus muscle-sparing thoracotomy on multiple parameters. Ann Thorac Surg. 2003;76(4):1050-1054. 5.Hazelrigg SR, Landreneau RJ, Boley TM, et al. The effect of muscle-sparing versus standard posterolateral thoracotomy on pulmonary function, muscle strength, and postoperative pain. J Thorac Cardiovasc Surg. 1991;101(3):394-400. 6.Kutlu CA, Akin H, Olcmen A, et al. Shoulder-girdle strength after standard and lateral muscle-sparing thoracotomy. Thorac Cardiovasc Surg. 2001;49(2):112-114. 7.Khan IH, McManus KG, McCraith A, et al. Muscle sparing thoracotomy: a biomechanical analysis confirms preservation of muscle strength but no improvement in wound discomfort. Eur J Cardiothorac Surg. 2000;18(6):656-661. 8.Baeza OR, Foster ED. Vertical axillary thoracotomy: a functional and cosmetically appealing incision. Ann Thorac Surg. 1976;22(3):287-288.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hao Long, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01102517     History of Changes
Other Study ID Numbers: 2007039
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by Hao Long, Sun Yat-sen University:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms