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

NCT ID: NCT01102517

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2018-12-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VATS group

video-assisted thoracoscopic surgery

Group Type: EXPERIMENTAL

video-assisted thoracoscopic surgery

Intervention Type: PROCEDURE

video-assisted thoracoscopic surgery

axillary thoracotomy

Control group

Group Type: OTHER

axillary thoracotomy

Intervention Type: PROCEDURE

axillary thoracotomy lobectomy

Interventions

video-assisted thoracoscopic surgery

video-assisted thoracoscopic surgery

Intervention Type: PROCEDURE

axillary thoracotomy

axillary thoracotomy lobectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: collaborator

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role: collaborator

Shenzhen People's Hospital

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Hao Long

Sun Yat-sen University Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hao Long, professor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 29198623 (View on PubMed)

Other Identifiers

2007039

Identifier Type: -

Identifier Source: org_study_id