Clinical trial NCT01337037: Modified Video-assisted Thoracoscopic Surgery (VATS) Lobectomy for Early-stage Non-small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: video-assisted thoracic surgery
Lung cancer
lobectomy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: West China Hospital
name: Sun Yat-sen University
name: The First Hospital of Jilin University
name: Central South University
name: Jiangsu Cancer Institute & Hospital
name: Beijing Friendship Hospital
name: Xuanwu Hospital, Beijing
name: Peking University
name: Fujian Provincial Hospital
name: Fuzhou General Hospital
name: Beijing Haidian Hospital
name: Fuzhou Pulmonary Hospital of Fujian
First posted: 2011-04-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: in hospital patients

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.

Eligibility criteria: Inclusion Criteria:

1. clinically diagnosed with stage I to stage II peripheral non-small cell lung cancer suitable for lobectomy.
2. signed informed consent from patient or legal representative, and allowed adequate follow-up.
3. operators must have experience of VATS lobectomy for more than 50 cases.

Exclusion Criteria:

1. pregnant or breastfeeding women.
2. severe complications or infections.
3. no prior chemotherapy or radiotherapy for this malignancy.
4. medical history of mediastinal or hilar lymphadenopathy.
5. current participation in another study involving an investigational device or drug.

Primary outcomes:
measure: Operative time
timeFrame: 6 weeks after surgery.
measure: Survival time
timeFrame: 5 years
measure: Hospital cost
timeFrame: 6 weeks after surgery.
Secondary outcomes:
measure: Quality of life
timeFrame: 1 year
measure: Pain Scale Evaluation
timeFrame: 6 weeks after surgery
measure: Blood loss
timeFrame: 3 months after surgery
measure: Postoperative mortality
timeFrame: 3 months after surgery
measure: Conversion rate
timeFrame: 6 weeks after surgery
measure: Disease-free survival time
timeFrame: 5 years after surgery
measure: Postoperative morbidity
timeFrame: 3 months after surgery
measure: Postoperative drainage duration
timeFrame: 3 months after surgery
measure: Postoperative hospital stay
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University
state: Beijing
city: Beijing
country: China
facility: Beijing Haidian hospital
state: Beijing
city: Beijing
country: China
facility: Department of Thoracic Surgery，Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Department of Thoracic Surgery，Peking University School of Oncology
state: Beijing
city: Beijing
country: China
facility: Department of Thoracic Surgery，Xuanwu Hospital Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: Department of Thoracic Surgery，Fuzhou Pulmonary Hospital of Fujian
state: Fujian
city: Fuzhou
country: China
facility: Department of Thoracic Surgery, Fuzhou General Hospital of Nanjing Military Command
state: Fujian
city: Fuzhou
country: China
facility: Department of Thoracic Surgery，Fujian Provincial Hospital
state: Fujian
city: Guangzhou
country: China
facility: Department of Oncologic Surgery, Sun Yat-sen Univisity Cancer Center
state: Guangdong
city: Changsha
country: China
facility: Department of Thoracic Surgery, the second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Department of Thoracic Surgery, Jiangsu Cancer Hospital
state: Jiangsu
city: Changchun
country: China
facility: Department of Thoracic Surgery，Jilin University Norman Bethune Hospital
state: Jilin
city: Shanghai
country: China
facility: Department of Thoracic Surgery，Zhongshan Hospital Fudan University
state: Shanghai
city: Chengdu
country: China
facility: Department of Thoracic Surgery, West China Hospital,Sichuan University
state: Sichuan
Study officials:
affiliation: Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University
name: Jun Wang, MD
role: STUDY_DIRECTOR
References:
citation: Li Yun, Wang Jun, Sui Xi-zhao, et al. Operative technique optimization in completely thoracoscopic lobectomy: Peking University experience: CHINESE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY 2010;26(5).