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

Non-small Cell Lung Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01102517
• Other study ID #: 2007039
• Status: Active, not recruiting
• Phase: N/A
• First received: April 6, 2010
• Last updated: February 27, 2018
• Start date: January 2010
• Est. completion date: December 2018

Study information

• Verified date: February 2018
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Procedure:
• video-assisted thoracoscopic surgery
video-assisted thoracoscopic surgery
• axillary thoracotomy
axillary thoracotomy lobectomy

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	GuangZhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Sun Yat-sen University	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Shanghai Chest Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival and overall survival		5 years
Secondary	Quality of life	Lung Cancer Symptom Scale	the first year after the surgery
Secondary	Postoperative pulmonary function		the first three months after the surgery
Secondary	Postoperative Karnofsky performance status		the first year after the surgery
Secondary	Postoperative Chest Pain	visual analogue scale and Wong-Baker FACES Pain Rating Scale	the first year after the surgery
Secondary	Perioperation data	operation time, intraoperative blood loss, chest tube drainage amount, duration of the chest tube placement, and duratio	perioperation
Secondary	Cytokines response	IL-2,IL-4,IL-6,IL-10,TNF,IFN-r	the first 48 hours after the surgery

External Links

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