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

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Procedure: video-assisted thoracoscopic surgery; Procedure: axillary thoracotomy

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VATS group; video-assisted thoracoscopic surgery	Procedure: video-assisted thoracoscopic surgery; video-assisted thoracoscopic surgery
Other: axillary thoracotomy; Control group	Procedure: axillary thoracotomy; axillary thoracotomy lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival and overall survival	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Shanghai Chest Hospital; Shenzhen People's Hospital; Shanghai Pulmonary Hospital, Shanghai, China; Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Investigators: Principal Investigator: Hao Long, professor, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.
• Long H, Tan Q, Luo Q, Wang Z, Jiang G, Situ D, Lin Y, Su X, Liu Q, Rong T. Thoracoscopic Surgery Versus Thoracotomy for Lung Cancer: Short-Term Outcomes of a Randomized Trial. Ann Thorac Surg. 2018 Feb;105(2):386-392. doi: 10.1016/j.athoracsur.2017.08.045. Epub 2017 Dec 2.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: April 6, 2010
• First Submitted That Met QC Criteria: April 12, 2010
• First Posted (Estimate): April 13, 2010

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: NSCLC; Clinical; Early-stage
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2007039