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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2011 by Peking University People's Hospital
Sponsor:
Collaborators:
Shanghai Zhongshan Hospital
West China Hospital
Sun Yat-sen University
First Hospital of Jilin University
Central South University
Jiangsu Cancer Institute & Hospital
Beijing Friendship Hospital
Xuanwu hospital capital medical university
Peking University
Fujian Provincial Hospital
Fuzhou General Hospital of Nanjing Military Command
Beijing Haidian Hospital
Fuzhou Pulmonary Hospital of Fujian
Information provided by (Responsible Party):
Jun Wang, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01337037
First received: April 6, 2011
Last updated: March 30, 2014
Last verified: March 2011
  Purpose

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.


Condition Intervention
Lung Cancer
Device: VATS lobectomy using modified equipments
Procedure: VATS lobectomy using less staples
Procedure: Standard VATS lobectomy
Procedure: Open lobectomy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years

Resource links provided by NLM:


Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • Operative time [ Time Frame: 6 weeks after surgery. ] [ Designated as safety issue: Yes ]
    For modified equipments group, if the operative time is significantly less than stand VATS group, the equipments is considered as feasible.

  • Survival time [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    overall survival rate(1-year, 3-year,5-year)will be analysed by the survival times of the follow-up patients.

  • Hospital cost [ Time Frame: 6 weeks after surgery. ] [ Designated as safety issue: No ]
    less staples group vs.standard VATS group


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    measured by Zubrod-ECOG-WHO score

  • Pain Scale Evaluation [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
    measured by Visual analog scale (VAS)

  • Blood loss [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 1000
Study Start Date: April 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
standard VATS group
patients undergo standard VATS lobectomy using non-modified equipments,without limits of staples
Procedure: 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.
modified equipments group
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.).
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.

less staples group
patients undergo VATS lobectomy with at most 4 staples used.
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.
open group
patients undergo lobectomy by thoracotomy approach
Procedure: Open lobectomy
standard lobectomy procedure by thoracotomy approach

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

in hospital patients

Criteria

Inclusion Criteria:

  1. clinically diagnosed with stage I to stage II peripheral non-small cell lung cancer suitable for lobectomy.
  2. no calcified hilar lymph nodes in the preoperative chest CT scan.
  3. signed informed consent from patient or legal representative, and allowed adequate follow-up.
  4. operators must have experience of VATS lobectomy for more than 150 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337037

Contacts
Contact: Guanchao Jiang, MD +86 10 88326656 jiangguanchao@yahoo.com
Contact: Xizhao Sui, MD +86 10 88325983 saul.sui@gmail.com

Locations
China, Beijing
Department of Thoracic Surgery,Xuanwu Hospital Capital Medical University Not yet recruiting
Beijing, Beijing, China
Contact: Xiuyi Zhi         
Department of Thoracic Surgery,Beijing Friendship Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Zhi Gao         
Beijing Haidian hospital Not yet recruiting
Beijing, Beijing, China
Contact: Jun Liu         
Contact: Yuqing Huang         
Department of Thoracic Surgery,Peking University School of Oncology Not yet recruiting
Beijing, Beijing, China
Contact: Yue Yang         
Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University Recruiting
Beijing, Beijing, China, 100044
Contact: Xizhao Sui, MD    +86 10 88325983    saul.sui@gmail.com   
Contact: Guanchao Jiang, MD    +86 10 88326656    jiangguanchao@yahoo.com   
China, Fujian
Department of Thoracic Surgery, Fuzhou General Hospital of Nanjing Military Command Not yet recruiting
Fuzhou, Fujian, China
Contact: Shengsheng Yang         
Department of Thoracic Surgery,Fujian Provincial Hospital Not yet recruiting
Fuzhou, Fujian, China
Contact: Xiaojie Pan         
Department of Thoracic Surgery,Fuzhou Pulmonary Hospital of Fujian Not yet recruiting
Fuzhou, Fujian, China, 350008
Contact: Zujian Dai         
China, Guangdong
Department of Oncologic Surgery, Sun Yat-sen Univisity Cancer Center Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jianhua Fu         
China, Hunan
Department of Thoracic Surgery, the second Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China, 410011
Contact: Feilei Yu         
China, Jiangsu
Department of Thoracic Surgery, Jiangsu Cancer Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210009
Contact: Lin Xu         
China, Jilin
Department of Thoracic Surgery,Jilin University Norman Bethune Hospital Not yet recruiting
Changchun, Jilin, China, 130021
Contact: Guoguang Shao         
China, Shanghai
Department of Thoracic Surgery,Zhongshan Hospital Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Qun Wang, MD         
China, Sichuan
Department of Thoracic Surgery, West China Hospital,Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Lunxu Liu         
Sponsors and Collaborators
Peking University People's Hospital
Shanghai Zhongshan Hospital
West China Hospital
Sun Yat-sen University
First Hospital of Jilin University
Central South University
Jiangsu Cancer Institute & Hospital
Beijing Friendship Hospital
Xuanwu hospital capital medical university
Peking University
Fujian Provincial Hospital
Fuzhou General Hospital of Nanjing Military Command
Beijing Haidian Hospital
Fuzhou Pulmonary Hospital of Fujian
Investigators
Study Director: Jun Wang, MD Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University
  More Information

Additional Information:
No publications provided

Responsible Party: Jun Wang, prof. Dr., Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01337037     History of Changes
Other Study ID Numbers: PHTD2010
Study First Received: April 6, 2011
Last Updated: March 30, 2014
Health Authority: China: Ministry of Health

Keywords provided by Peking University People's Hospital:
video-assisted thoracic surgery
Lung cancer
lobectomy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014