VATS (video-assisted thoracoscopic surgery) lobectomy is a relatively new minimally invasive
surgical treatment for early-stage non-small cell lung cancer (NSCLC), associated with low
morbidity and mortality and effective oncologic results over the standard thoracotomy.
However, this surgical procedure has not spread widely in china for several reasons. First ,
VATS surgery cost more than thoracotomy for thoracoscopic staples; second, the procedure of
VATS lobectomy may be more difficult in china as the lack of VATS surgical equipments
adjusted for smaller thoracic cavity of chinese, and more common adhesive and calcified
lymph nodes due to infection and tuberculosis; Third, the surgical levels of VATS lobectomy
are far from equal in china, and the Continuing Medical Education training programs of
thoracoscopic surgery seem to be less efficient without major criterion.
The purpose of this study is to modify the surgical technique of VATS (video-assisted
thoracoscopic surgery) lobectomy for early-stage non-small cell lung cancer, to examine the
feasibility of VATS lobectomy performed by less staples, and to evaluate the feasibility of
VATS lobectomy performed by modified surgical equipments designed according to the
experience of chinese lobectomy surgery, and to generate a chinese standard operative
procedure of VATS lobectomy for technique learning and spread. The investigators will intend
to recruit 250 patients each group, for 4 groups. Group A(open group) will undergo radical
lobectomy via thoracotomy approach. Group B(standard VATS group) will undergo lobectomy via
standard VATS approach introduced. Group C(less staples group) will undergo lobectomy via
VATS approach with staples limitation. Group D(modified equipments group) will undergo
lobectomy via VATS approach using VATS surgical equipments designed according to the
experience of chinese lobectomy surgery. The investigators will compare two groups of
patients as followed: A vs. B, B vs. C, B vs. D.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Operative time
For modified equipments group, if the operative time is significantly less than stand VATS group, the equipments is considered as feasible.
6 weeks after surgery.
Yes
Jun Wang, MD
Study Director
Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University
China: Ministry of Health
PHTD2010
NCT01337037
April 2011
December 2016
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