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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
the procedure of this group is the same with standard VATS lobectomy group.the VATS surgical equipments used in the group are designed according to the experience of chinese lobectomy surgery. All the patent applications of the surgical equipments are granted. proprietor of the patents is Jun Wang, head of Department of Thoracic surgery of people's hospital, peking university. Details of the modified equipments: Lobectomy Equipments Pack (Manufacturer B.J.ZH.F.Panther Medical Equipment Co.,Ltd.) consists of 8 basic surgical equipments, which are crafoord dissecting and ligature forcep, Yankauer suction tube, mixter dissecting and ligature forceps(long),mixter dissecting and ligature forceps(short), atraumatic-grip aorta-aneurysma clamp with toothing De Bakey, De Bakey atraumatic-grip vascular forcep, Bozemann tite grip needle holder, Winter placenta and ovum forcep.
VATS lobectomy with at most 4 staples used, aimed at reduced hospital cost.This procedure is similar with the standard VATS lobectomy procedure without staples limits. The lobar vessels and bronchus are stapled. However, the interlobar fissures should be deal with electronic cautery, harmonic scalpel,or suturing.
Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University
Beijing, Beijing Municipality, China
RECRUITINGOperative time
For modified equipments group, if the operative time is significantly less than stand VATS group, the equipments is considered as feasible.
Time frame: 6 weeks after surgery.
Survival time
overall survival rate(1-year, 3-year,5-year)will be analysed by the survival times of the follow-up patients.
Time frame: 5 years
Hospital cost
less staples group vs.standard VATS group
Time frame: 6 weeks after surgery.
Quality of life
measured by Zubrod-ECOG-WHO score
Time frame: 1 year
Pain Scale Evaluation
measured by Visual analog scale (VAS)
Time frame: 6 weeks after surgery
Blood loss
to evaluate the blood loss volume as followed:open group vs. standard VATS group; modified equipments group vs. standard VATS group; less staples group vs.standard VATS group.
Time frame: 3 months after surgery
Postoperative mortality
to evaluate the postoperative mortality as followed: open group vs. standard VATS group; modified equipments group vs. standard VATS group; less staples group vs.standard VATS group.
Time frame: 3 months after surgery
Conversion rate
For modified equipments group, if conversion rates is not significantly different with stand VATS group, and success rate is over 90%, VATS lobectomy is considered as feasible.
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VATS lobectomy without new equipments and limitation of staples, same with the current procedure of VATS lobectomy performed in thoracic departments of Peking university people's hospital and the Collaborators. All procedures were conducted under general anesthesia with double lumen intubation. The thoracoscope was introduced through 7th or 8th intercostals space on the mid-axillaries line. The 4 cm long utility incision was made on the 4th or 5th intercostals space anterior axillary's line without rib-spreading. A third retraction incision located on the 7th or 8th intercostals space sub-scapular line. The surgeon stands on the ventral side of patient using an electrocautery hook and a suction device through the utility incision. Anatomic lobectomy was performed with systemic mediastinal lymph node dissection for lung cancer patients.
standard lobectomy procedure by thoracotomy approach
Beijing Haidian hospital
Beijing, Beijing Municipality, China
RECRUITINGDepartment of Thoracic Surgery，Beijing Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGDepartment of Thoracic Surgery，Peking University School of Oncology
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGDepartment of Thoracic Surgery，Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGDepartment of Thoracic Surgery，Fuzhou Pulmonary Hospital of Fujian
Fuzhou, Fujian, China
RECRUITINGDepartment of Thoracic Surgery, Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, China
RECRUITINGDepartment of Thoracic Surgery，Fujian Provincial Hospital
Fuzhou, Fujian, China
RECRUITINGDepartment of Oncologic Surgery, Sun Yat-sen Univisity Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGDepartment of Thoracic Surgery, the second Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITING...and 4 more locations
Time frame: 6 weeks after surgery
Disease-free survival time
overall Disease-free survival rate(1-year, 3-year,5-year)will be analysed by the survival times of the follow-up patients.
Time frame: 5 years after surgery
Postoperative morbidity
to evaluate the postoperative morbidity above as followed: open group vs. standard VATS group; modified equipments group vs. standard VATS group; less staples group vs.standard VATS group.
Time frame: 3 months after surgery
Postoperative drainage duration
to evaluate the postoperative drainage duration as followed: open group vs. standard VATS group; modified equipments group vs. standard VATS group; less staples group vs.standard VATS group.
Time frame: 3 months after surgery
Postoperative hospital stay
to evaluate the postoperative hospital stay above as followed: open group vs. standard VATS group; modified equipments group vs. standard VATS group; less staples group vs.standard VATS group.
Time frame: 3 months after surgery