Lung CancerNCT01337037
Modified Video-assisted Thoracoscopic Surgery (VATS) Lobectomy for Early-stage Non-small Cell Lung Cancer (NSCLC)
An observational study of Lung Cancer, run by Peking University People's Hospital at 14 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- VATS lobectomy using modified equipments, VATS lobectomy using less staples and Standard VATS lobectomy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 14 sitesChina
- Study dates
- Apr 2011to Dec 2016
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: in hospital patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University
Beijing, Beijing Municipality, 100044
Xizhao Sui, MD, +86 10 88325983, saul.sui@gmail.com
Guanchao Jiang, MD, +86 10 88326656, jiangguanchao@yahoo.com
- Recruiting
Beijing Haidian hospital
Beijing, Beijing Municipality
Jun Liu
Yuqing Huang
- Recruiting
Department of Thoracic Surgery，Beijing Friendship Hospital
Beijing, Beijing Municipality
Zhi Gao
- Not yet recruiting
Department of Thoracic Surgery，Peking University School of Oncology
Beijing, Beijing Municipality
Yue Yang
- Not yet recruiting
Department of Thoracic Surgery，Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality
Xiuyi Zhi
- Recruiting
Department of Thoracic Surgery，Jilin University Norman Bethune Hospital
Changchun, Jilin, 130021
Guoguang Shao
- Recruiting
Department of Thoracic Surgery, the second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Feilei Yu
- Not yet recruiting
Department of Thoracic Surgery, West China Hospital,Sichuan University
Chengdu, Sichuan, 610041
Lunxu Liu
- Recruiting
Department of Thoracic Surgery，Fuzhou Pulmonary Hospital of Fujian
Fuzhou, Fujian, 350008
Zujian Dai
- Recruiting
Department of Thoracic Surgery, Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian
Shengsheng Yang
- Recruiting
Department of Thoracic Surgery，Fujian Provincial Hospital
Fuzhou, Fujian
Xiaojie Pan
- Not yet recruiting
Department of Oncologic Surgery, Sun Yat-sen Univisity Cancer Center
Guangzhou, Guangdong, 510060
Jianhua Fu
- Recruiting
Department of Thoracic Surgery, Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Lin Xu
- Recruiting
Department of Thoracic Surgery，Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Qun Wang, MD
About this study
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- VATS lobectomy using modified equipments, VATS lobectomy using less staples, Standard VATS lobectomy, Open lobectomy
- Keywords
- video-assisted thoracic surgery, Lung cancer, lobectomy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
VATS lobectomy using less staplesProcedure or surgery
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 lobectomyProcedure or surgery
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 lobectomyProcedure or surgery
standard lobectomy procedure by thoracotomy approach
| Study group | Role | What they receive |
|---|---|---|
| standard VATS group | patients undergo standard VATS lobectomy using non-modified equipments,without limits of staples Receives: 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.). Receives: Device: VATS lobectomy using modified equipments | |
| less staples group | patients undergo VATS lobectomy with at most 4 staples used. Receives: Procedure: VATS lobectomy using less staples | |
| open group | patients undergo lobectomy by thoracotomy approach Receives: Procedure: Open lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
For modified equipments group, if the operative time is significantly less than stand VATS group, the equipments is considered as feasible.
Measured: 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.
Measured: 5 years
Hospital cost
less staples group vs.standard VATS group
Measured: 6 weeks after surgery.
Secondary outcomes (9)
Quality of life
measured by Zubrod-ECOG-WHO score
Measured: 1 year
Pain Scale Evaluation
measured by Visual analog scale (VAS)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
- Investigators
- Jun Wang, MD, Study director, Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337037
- Sponsor's protocol ID
- PHTD2010
- Status last verified
- Jan 2015
- First submitted
- 6 Apr 2011
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Video-assisted Thoracoscopic Surgery (VATS) Lobectomy for Early-stage Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01337037
- Acronym / sponsor ID
- PHTD2010
- Conditions
- Lung Cancer
- Keywords
- video-assisted thoracic surgery, Lung cancer, lobectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- 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
- Study start
- Apr 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| standard VATS group | – | Procedure: Standard VATS lobectomypatients undergo standard VATS lobectomy using non-modified equipments,without limits of staples |
| modified equipments group | – | Device: VATS lobectomy using modified equipmentspatients 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.). |
| less staples group | – | Procedure: VATS lobectomy using less staplespatients undergo VATS lobectomy with at most 4 staples used. |
| open group | – | Procedure: Open lobectomypatients undergo lobectomy by thoracotomy approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- in hospital patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VATS lobectomy using modified equipmentsthe 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. | Device | modified equipments group |
| VATS lobectomy using less staplesVATS 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. | Procedure or surgery | less staples group |
| Standard VATS lobectomyVATS 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. | Procedure or surgery | standard VATS group |
| Open lobectomystandard lobectomy procedure by thoracotomy approach | Procedure or surgery | open group |
Primary outcome
Operative time
Time frame: 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
Time frame: 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
Time frame: 6 weeks after surgery.
less staples group vs.standard VATS group
9 secondary outcomes
Quality of life
Time frame: 1 year
Pain Scale Evaluation
Time frame: 6 weeks after surgery
Blood loss
Time frame: 3 months after surgery
Postoperative mortality
Time frame: 3 months after surgery
Conversion rate
Time frame: 6 weeks after surgery
Disease-free survival time
Time frame: 5 years after surgery
Postoperative morbidity
Time frame: 3 months after surgery
Postoperative drainage duration
Time frame: 3 months after surgery
Postoperative hospital stay
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- BackgroundLi 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Wang, MD study director
Department of Thoracic Surgery, Center for Mini-invasive Thoracic Surgery, People's Hospital, Peking University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Peking University People's Hospital at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guanchao Jiang, MD (+86 10 88326656, jiangguanchao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: 6 weeks after surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01337037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015.