Modified Video-assisted Thoracoscopic Surgery (VATS) Lobectomy for Early-stage Non-small Cell Lung Cancer (NSCLC)
- Conditions
- Lung Cancer
- Interventions
- Procedure: Open lobectomyProcedure: Standard VATS lobectomyDevice: VATS lobectomy using modified equipmentsProcedure: VATS lobectomy using less staples
- Registration Number
- NCT01337037
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- clinically diagnosed with stage I to stage II peripheral non-small cell lung cancer suitable for lobectomy.
- signed informed consent from patient or legal representative, and allowed adequate follow-up.
- operators must have experience of VATS lobectomy for more than 50 cases.
- pregnant or breastfeeding women.
- severe complications or infections.
- no prior chemotherapy or radiotherapy for this malignancy.
- medical history of mediastinal or hilar lymphadenopathy.
- current participation in another study involving an investigational device or drug.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description open group Open lobectomy patients undergo lobectomy by thoracotomy approach standard VATS group Standard VATS lobectomy patients undergo standard VATS lobectomy using non-modified equipments,without limits of staples modified equipments group VATS lobectomy using modified equipments patients undergo VATS lobectomy with modified VATS lobectomy equipments designed designed according to the experience of chinese lobectomy surgery: Lobectomy Equipments Pack (Manufacturer B.J.ZH.F.Panther Medical Equipment Co.,Ltd.). less staples group VATS lobectomy using less staples patients undergo VATS lobectomy with at most 4 staples used.
- Primary Outcome Measures
Name Time Method Hospital cost 6 weeks after surgery. less staples group vs.standard VATS group
Operative time 6 weeks after surgery. For modified equipments group, if the operative time is significantly less than stand VATS group, the equipments is considered as feasible.
Survival time 5 years overall survival rate(1-year, 3-year,5-year)will be analysed by the survival times of the follow-up patients.
- Secondary Outcome Measures
Name Time Method Pain Scale Evaluation 6 weeks after surgery measured by Visual analog scale (VAS)
Quality of life 1 year measured by Zubrod-ECOG-WHO score
Conversion rate 6 weeks after surgery 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.
Disease-free survival time 5 years after surgery overall Disease-free survival rate(1-year, 3-year,5-year)will be analysed by the survival times of the follow-up patients.
Postoperative morbidity 3 months after surgery 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.
Postoperative drainage duration 3 months after surgery 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.
Postoperative hospital stay 3 months after surgery 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.
Blood loss 3 months after surgery 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.
Postoperative mortality 3 months after surgery 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.
Trial Locations
- Locations (14)
Department of Thoracic Surgery，Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
Department of Thoracic Surgery，Jilin University Norman Bethune Hospital
🇨🇳Changchun, Jilin, China
Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University
🇨🇳Beijing, Beijing, China
Department of Thoracic Surgery, the second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Department of Thoracic Surgery, Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Department of Oncologic Surgery, Sun Yat-sen Univisity Cancer Center
🇨🇳Guangzhou, Guangdong, China
Department of Thoracic Surgery，Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Department of Thoracic Surgery, West China Hospital,Sichuan University
🇨🇳Chengdu, Sichuan, China
Department of Thoracic Surgery，Peking University School of Oncology
🇨🇳Beijing, Beijing, China
Department of Thoracic Surgery，Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Beijing Haidian hospital
🇨🇳Beijing, Beijing, China
Department of Thoracic Surgery，Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Department of Thoracic Surgery，Fuzhou Pulmonary Hospital of Fujian
🇨🇳Fuzhou, Fujian, China
Department of Thoracic Surgery, Fuzhou General Hospital of Nanjing Military Command
🇨🇳Fuzhou, Fujian, China