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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: Standard VATS lobectomy; Device: VATS lobectomy using modified equipments; Procedure: VATS lobectomy using less staples; Procedure: Open lobectomy

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Guanchao Jiang, MD; Phone Number: +86 10 88326656; Email: jiangguanchao@yahoo.com
• Study Contact Backup: Name: Xizhao Sui, MD; Phone Number: +86 10 88325983; Email: saul.sui@gmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

in hospital patients

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
Hospital cost	less staples group vs.standard VATS group	6 weeks after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	measured by Zubrod-ECOG-WHO score	1 year
Pain Scale Evaluation	measured by Visual analog scale (VAS)	6 weeks after surgery
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Peking University; Sun Yat-sen University; Beijing Friendship Hospital; Shanghai Zhongshan Hospital; West China Hospital; Xuanwu Hospital, Beijing; Fuzhou Pulmonary Hospital of Fujian; Jiangsu Cancer Institute & Hospital; The First Hospital of Jilin University; Central South University; Beijing Haidian Hospital; Fuzhou General Hospital; Fujian Provincial Hospital
• Investigators: Study Director: Jun Wang, MD, Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University

Publications and helpful links

General Publications

• 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).

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: April 6, 2011
• First Submitted That Met QC Criteria: April 15, 2011
• First Posted (Estimate): April 18, 2011

Study Record Updates

• Last Update Posted (Estimate): January 27, 2015
• Last Update Submitted That Met QC Criteria: January 24, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Lung cancer; lobectomy; video-assisted thoracic surgery
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: PHTD2010