Modified Video-assisted Thoracoscopic Surgery (VATS) Lobectomy for Early-stage Non-small Cell Lung Cancer (NSCLC)

Lung Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01337037
• Other study ID #: PHTD2010
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2011
• Last updated: January 24, 2015
• Start date: April 2011
• Est. completion date: December 2016

Study information

• Verified date: January 2015
• Source: Peking University People's Hospital
• Contact: Guanchao Jiang, MD
• Phone: +86 10 88326656
• Email: jiangguanchao[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Device:
• VATS 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.

Procedure:
• VATS 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.
• Standard 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.
• Open lobectomy
standard lobectomy procedure by thoracotomy approach

Locations

Country	Name	City	State
China	Beijing Haidian hospital	Beijing	Beijing
China	Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University	Beijing	Beijing
China	Department of Thoracic Surgery,Beijing Friendship Hospital	Beijing	Beijing
China	Department of Thoracic Surgery,Peking University School of Oncology	Beijing	Beijing
China	Department of Thoracic Surgery,Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	Department of Thoracic Surgery,Jilin University Norman Bethune Hospital	Changchun	Jilin
China	Department of Thoracic Surgery, the second Xiangya Hospital of Central South University	Changsha	Hunan
China	Department of Thoracic Surgery, West China Hospital,Sichuan University	Chengdu	Sichuan
China	Department of Thoracic Surgery, Fuzhou General Hospital of Nanjing Military Command	Fuzhou	Fujian
China	Department of Thoracic Surgery,Fujian Provincial Hospital	Fuzhou	Fujian
China	Department of Thoracic Surgery,Fuzhou Pulmonary Hospital of Fujian	Fuzhou	Fujian
China	Department of Oncologic Surgery, Sun Yat-sen Univisity Cancer Center	Guangzhou	Guangdong
China	Department of Thoracic Surgery, Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Department of Thoracic Surgery,Zhongshan Hospital Fudan University	Shanghai	Shanghai

Sponsors (14)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing Friendship Hospital, Beijing Haidian Hospital, Central South University, First Hospital of Jilin University, Fujian Provincial Hospital, Fuzhou General Hospital, Fuzhou Pulmonary Hospital of Fujian, Jiangsu Cancer Institute & Hospital, Peking University, Shanghai Zhongshan Hospital, Sun Yat-sen University, West China Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (1)

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).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Survival time	overall survival rate(1-year, 3-year,5-year)will be analysed by the survival times of the follow-up patients.	5 years	Yes
Primary	Hospital cost	less staples group vs.standard VATS group	6 weeks after surgery.	No
Secondary	Quality of life	measured by Zubrod-ECOG-WHO score	1 year	No
Secondary	Pain Scale Evaluation	measured by Visual analog scale (VAS)	6 weeks after surgery	No
Secondary	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.	3 months after surgery	Yes
Secondary	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.	3 months after surgery	Yes
Secondary	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.	6 weeks after surgery	Yes
Secondary	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.	5 years after surgery	Yes
Secondary	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.	3 months after surgery	Yes
Secondary	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.	3 months after surgery	Yes
Secondary	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.	3 months after surgery	Yes

External Links

•   Peking University experience of thoracoscopic lobectomy