Clinical trial NCT01102517: A Trial on Video-assisted Thoracoscopic Surgery and Axillary Thoracotomy for Resection of Early-stage Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Clinical
Early-stage
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Shanghai Chest Hospital
name: Shanghai Pulmonary Hospital, Shanghai, China
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Shenzhen People's Hospital
First posted: 2010-04-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Disease-free survival and overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Quality of life
timeFrame: the first year after the surgery
measure: Postoperative pulmonary function
timeFrame: the first three months after the surgery
measure: Postoperative Karnofsky performance status
timeFrame: the first year after the surgery
measure: Postoperative Chest Pain
timeFrame: the first year after the surgery
measure: Perioperation data
timeFrame: perioperation
measure: Cytokines response
timeFrame: the first 48 hours after the surgery
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Hao Long, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.