NCT01337037

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

5.7 years

First QC Date

April 6, 2011

Last Update Submit

January 24, 2015

Conditions

Lung Cancer

Keywords

video-assisted thoracic surgeryLung cancerlobectomy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Quality of life

    1 year

  • Pain Scale Evaluation

    6 weeks after surgery

  • Blood loss

    3 months after surgery

  • Postoperative mortality

    3 months after surgery

  • Conversion rate

    6 weeks after surgery

  • +4 more secondary outcomes

Study Arms (4)

standard VATS group

patients undergo standard VATS lobectomy using non-modified equipments,without limits of staples

Procedure: Standard VATS lobectomy

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

less staples group

patients undergo VATS lobectomy with at most 4 staples used.

Procedure: VATS lobectomy using less staples

open group

patients undergo lobectomy by thoracotomy approach

Procedure: Open lobectomy

Interventions

VATS lobectomy using modified equipmentsDEVICE

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.

modified equipments group
VATS lobectomy using less staplesPROCEDURE

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.

less staples group
Standard VATS lobectomyPROCEDURE

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.

standard VATS group
Open lobectomyPROCEDURE

standard lobectomy procedure by thoracotomy approach

open group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

in hospital patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University

Beijing, Beijing Municipality, 100044, China

RECRUITING

Beijing Haidian hospital

Beijing, Beijing Municipality, China

RECRUITING

Department of Thoracic Surgery，Beijing Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

Department of Thoracic Surgery，Peking University School of Oncology

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Department of Thoracic Surgery，Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Department of Thoracic Surgery，Fuzhou Pulmonary Hospital of Fujian

Fuzhou, Fujian, 350008, China

RECRUITING

Department of Thoracic Surgery, Fuzhou General Hospital of Nanjing Military Command

Fuzhou, Fujian, China

RECRUITING

Department of Thoracic Surgery，Fujian Provincial Hospital

Fuzhou, Fujian, China

RECRUITING

Department of Oncologic Surgery, Sun Yat-sen Univisity Cancer Center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

Department of Thoracic Surgery, the second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Department of Thoracic Surgery, Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

Department of Thoracic Surgery，Jilin University Norman Bethune Hospital

Changchun, Jilin, 130021, China

RECRUITING

Department of Thoracic Surgery，Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Department of Thoracic Surgery, West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Related 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).

    BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jun Wang, MD

    Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University

    STUDY DIRECTOR

Central Study Contacts

Guanchao Jiang, MD

CONTACT

+86 10 88326656jiangguanchao@yahoo.com

Xizhao Sui, MD

CONTACT

+86 10 88325983saul.sui@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. Dr.

Study Record Dates

First Submitted

April 6, 2011

First Posted

April 18, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations

CN(14)