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

NCT01102517 | Unknown DMC

• 1 other identifier: 2007039
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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. 1.To evaluate the early clinical benefits of VATS lobectomy when compared with the axillary thoracotomy.
2. 2.To evaluate the late effects of VATS lobectomy on survival and quality of life when compared with axillary thoracotomy.
3. 3.To establish the normative pattern of VATS lobectomy for early-stage non-small cell lung cancer.
4. 4.To explore the indication of VATS lobectomy for the lung cancer.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; Clinical; Early-stage

Outcome Measures

Primary Outcomes (1)

• Disease-free survival and overall survival

  5 years

Secondary Outcomes (6)

• Quality of life

  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

  the first year after the surgery

• Perioperation data

  perioperation

Study Arms (2)

VATS group

EXPERIMENTAL

video-assisted thoracoscopic surgery

Procedure: video-assisted thoracoscopic surgery

axillary thoracotomy

OTHER

Control group

Procedure: axillary thoracotomy

Interventions

video-assisted thoracoscopic surgery PROCEDURE

video-assisted thoracoscopic surgery

VATS group

axillary thoracotomy PROCEDURE

axillary thoracotomy lobectomy

axillary thoracotomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Shanghai Chest Hospital: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: collaborator
• Shenzhen People's Hospital: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (2)

• 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.

  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.

  PMID: 29198623 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Hao Long, professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 13, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

CN (1)