Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

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

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.).

patients undergo VATS lobectomy with at most 4 staples used.

patients undergo lobectomy by thoracotomy approach

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 modified equipments

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.

VATS lobectomy using less staples

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 lobectomy

standard lobectomy procedure by thoracotomy approach

Open lobectomy

Guanchao Jiang, MD

Xizhao Sui, MD

Jun Liu

Yuqing Huang

Zhi Gao

Yue Yang

Xiuyi Zhi

Zujian Dai

Shengsheng Yang

Xiaojie Pan

Jianhua Fu

Feilei Yu

Lin Xu

Guoguang Shao

Qun Wang, MD

Lunxu Liu

Jun Wang, MD

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.

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.

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

For modified equipments group, if the operative time is significantly less than stand VATS group, the equipments is considered as feasible.

overall survival rate(1-year, 3-year,5-year)will be analysed by the survival times of the follow-up patients.

less staples group vs.standard VATS group

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.

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.

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.

overall Disease-free survival rate(1-year, 3-year,5-year)will be analysed by the survival times of the follow-up patients.

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.

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.

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.

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

Peking University People's Hospital

prof. Dr.

Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent robotic-assisted lobectomy for lung cancer.

Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent VATS lobectomy for lung cancer.

Pre-operative, intra-operative and post-operative clinical, surgical and oncological information will be obtained from institutional records for patients who underwent open lobectomy for lung cancer.

Robotic-assisted lobectomy using da Vinci Surgical System

VATS (video assisted thoracic surgery)

The main objective of this study is to evaluate and compare peri-operative outcomes of lobectomy compare with different approaches. The study aims to include patients with stage IA, IB, IIA, IIB and IIIA lung cancer that underwent lobectomy via robotic-assisted, VATS and open approach.

This is a multi-center, retrospective chart review study of all consecutive lobectomies performed for clinical stage IA, IB, IIA, IIB and IIIA lung cancer, performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of lobectomy performed for clinical stages, IA, IB, IIA, IIB and IIIA lung cancer via robotic-assisted, VATS (video assisted thoracic surgery) and open approach that meet the study inclusion and exclusion criteria will be considered for inclusion in the study. The chart review and data collection will be performed in a reverse chronological order starting at 30 days prior to IRB approval of the study at the institution and going back to 2013 (i.e most current data in 2017 and chronologically going back through 2013). The retrospective chart review and data collection is anticipated to occur in two phases:

Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes data will be obtained from hospital records. Each participating institution will contribute approximately 100-800 cases from one or more surgeons. Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment and no patient consenting is required

Retrospective Multi-Center Study to Compare Perioperative Outcomes for Robotic-assisted Lobectomy With Those Associated With VATS and Open Lobectomy for Lung Cancer

A Retrospective Multi-Center Study for Evaluation of Clinical Outcomes With Lobectomy for Lung Cancer

Compare peri-operative outcomes of robotic-assisted lobectomy with those associated with VATS and open lobectomy for lung cancer

Intuitive Surgical

Lobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading.

Thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading.

Robot-assisted lobectomy with mediastinal lymph node dissection (Robot group as clinical assignment in prospective Cohort).

OPEN lobectomy

VATS lobectomy

ROBOT-assisted lobectomy

Thomas J van Brakel, MD, PhD

A. Verhagen, MD

A. Verhagen Verhagen, MD

T. van Brakel, MD, PhD

In patients with early stage lung cancer surgical lobectomy is the treatment of choice. A resection by Video-assisted Thoracic Surgery (VATS) is probably superior to an open procedure by thoracotomy for patients with early stage lung cancer, but randomized evidence for superiority is lacking. Furthermore, VATS lobectomy has not gained broad implementation yet. The objective of this study is to assess the benefits of VATS- over open lobectomy regarding quality of life and costs in a prospective randomized controlled multicenter trial. All patients meeting the inclusion criteria that are not randomized will be included in a prospective Cohort.

Rationale: Surgical lobectomy is the treatment of choice for patients with early stage lung cancer. In some centres, video-assisted thoracic surgery (VATS) lobectomy is preferred, where other centres hold on to the conventional open lobectomy via a thoracotomy. Although several studies have demonstrated fewer postoperative complications and shorter hospital length of stay for the VATS procedure, others have reported concerns regarding oncologic equivalence, mainly based on incomplete lymph node staging. Convincing randomized evidence from the literature is lacking. The aim of this randomized multicentre study is to compare quality of life, oncologic endpoints and cost-effectiveness between VATS- and open (thoracotomy) lobectomy.

Objective: To compare quality of life, cost-effectiveness and number of dissected mediastinal lymph nodes between open,VATS and ROBOT-assisted lobectomy.

Study design: A prospective multi-centre randomized trial with a prospective registry arm Study population: Adult patients of either gender, selected by the pulmonary oncological multidisciplinary team to undergo surgical lobectomy for early-stage lung carcinoma.

Intervention: One group is assigned to the open procedure: posterolateral thoracotomy for lobectomy with mediastinal lymph node dissection. The other group is assigned to the VATS procedure: thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection. All patients that do meet the inclusion criteria but are not participating in the randomized trial can be included in the prospective Cohort arm of the study evaluating clinical assignment to OPEN- VATS or ROBOT-assisted lobectomy.

Main study parameters/endpoints: Primary endpoints are postoperative quality of life, and hospital length of stay. Secondary endpoints include cancer specific quality of life, number of dissected mediastinal lymph nodes and stations, procedural complication rates, pulmonary function, overall costs and survival.

Centres participating in this study currently perform the open- and VATS and/or ROBOT-assisted lobectomy in daily clinical practice.

Treatment of Early Stage Lung Cancer by VATS Versus OPEN Lobectomy

thoracoSCopic Versus OPen Lobectomy for Early Stage Lung Cancer: a Randomized Prospective Trial

Primary endpoints include Quality of life assessed by EQ5D for VATS versus open lobectomy in patients with early stage non small cell lung carcinoma.

The number of intraoperatively dissected mediastinal lymphnode stations is assessed as a secondary oncologic outcome measure.

This secondary composite endpoints include conversion rate, bleeding, air leakage, pain, cardiac arrhythmias, wound infection, pulmonary complications, pulmonary function.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Modified Video-assisted Thoracoscopic Surgery (VATS) Lobectomy for Early-stage Non-small Cell Lung Cancer (NSCLC)	NCT01337037	Lung Cancer	VATS lobectomy ... VATS lobectomy ... Standard VATS l... Open lobectomy	18 Years -	Peking University People's Hospital
Retrospective Multi-Center Study to Compare Perioperative Outcomes for Robotic-assisted Lobectomy With Those Associated With VATS and Open Lobectomy for Lung Cancer	NCT03347825	Lung Cancer	Robotic-assiste... VATS (video ass... Open lobectomy	18 Years -	Intuitive Surgical
Modified Video-assisted Thoracoscopic Surgery (VATS) Lobectomy for Early-stage Non-small Cell Lung Cancer (NSCLC)	NCT01337037	Lung Cancer	VATS lobectomy ... VATS lobectomy ... Standard VATS l... Open lobectomy	18 Years -	Peking University People's Hospital
Treatment of Early Stage Lung Cancer by VATS Versus OPEN Lobectomy	NCT01933828	Lung Cancer	OPEN lobectomy VATS lobectomy ROBOT-assisted ...	18 Years -	Radboud University Medical Center

Spots Global Cancer Trial Database for open lobectomy