Lung Cancer
Conditions
Keywords
video-assisted thoracic surgery, Lung cancer, lobectomy
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.
Interventions
PROCEDUREOpen lobectomy
standard lobectomy procedure by thoracotomy approach
DEVICEVATS lobectomy using modified equipments
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.
PROCEDUREVATS lobectomy using less staples
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.
PROCEDUREStandard VATS lobectomy
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.
Sponsors
Shanghai Zhongshan Hospital
West China Hospital
Sun Yat-sen University
The First Hospital of Jilin University
Central South University
Jiangsu Cancer Institute & Hospital
Beijing Friendship Hospital
Xuanwu Hospital, Beijing
Peking University
Fujian Provincial Hospital
Fuzhou General Hospital
Beijing Haidian Hospital
Fuzhou Pulmonary Hospital of Fujian
Peking University People's Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Hospital cost | 6 weeks after surgery. | less staples group vs.standard VATS group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Quality of life | 1 year | measured by Zubrod-ECOG-WHO score |
| 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. |
| 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. |
| Pain Scale Evaluation | 6 weeks after surgery | measured by Visual analog scale (VAS) |
| 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. |
Countries
China
Contacts
Primary ContactGuanchao Jiang, MD
Backup ContactXizhao Sui, MD
Outcome results
None listed