To hear about similar clinical trials, please enter your email below

Trial Title: Robot-Assisted vs. Video-Assisted Lobectomy for NSCLC (RAVAR)

NCT ID: NCT06524427

Condition: Non Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Non-small cell lung cancer
Robotic-assisted lobectomy
Video-assisted lobectomy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Robot-assisted lobectomy
Description: Patients will receive robot-assisted lobectomy using Da Vinci surgical system
Arm group label: RATS group

Intervention type: Procedure
Intervention name: Video-assisted lobectomy
Description: Patients will receive video-assisted lobectomy
Arm group label: VATS group

Summary: Video-assisted thoracic surgery (VATS) has been recommended by clinical guidelines as one of the preferred surgeries for early-stage non-small cell lung cancer (NSCLC) for many years. However, VATS has inherent drawbacks, so at the beginning of this century, robotic-assisted thoracoscopic surgery (RATS) was first applied for lung resection. In recent years, RATS has developed rapidly, but there are still many unsolved scientific problems in the field of RATS. Thus, a multicenter prospective randomized controlled trial was conducted with stage I-II NSCLC patients as the study subject and 5-year DFS as the primary endpoint to compare the short-term and long-term outcomes of RATS and VATS in the treatment of early-stage NSCLC.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Age from 18 to 80 years old; 2. Patients with blood pressure<160/100mmHg, 5.6= 40 % and diffusing capacity of the lung for carbon monoxide (DLCO) >= 40 %; (3) total bilirubin <= 1.5 upper limit of normal; (4) Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) <= 2.5 upper limit of normal; (5) creatinine <= 1.25 upper limit of normal and creatinine clearance rate (CCr) >= 60ml/min; 3. The first clinical diagnosis before surgery was non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other unknown types; 4. Clinical stage T1-2N0-1 (cI-II): Maximum diameter of tumor <= 5cm and short diameter of mediastinal lymph node <= 1cm in thin layer CT; 5. Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1; 6. All relevant examinations were completed within 28 days before the operation; 7. Patients who understand this study and have signed an approved Informed Consent. Exclusion Criteria: 1. Patients with radiotherapy, chemotherapy, targeted therapy, or immunotherapy before surgery. 2. Patients with the previous history of other malignancies; 3. Patients with secondary primary cancer when enrolled; 4. Patients diagnosed as pure ground glass opacity (GGO) before surgery; 5. Patients diagnosed as mixed GGO whose solid part <= 50% and Maximum diameter of tumor <= 2cm; 6. Patients with small cell lung cancer; 7. Patients with prior unilateral open thoracic surgical procedures; 8. Woman who is pregnant or breastfeeding; 9. Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema; 10. Patients with an active bacterial or fungal infection that is difficult to control; 11. Patients with serious psychosis; 12. Patients with a history of severe heart attack, heart failure, myocardial infarction, or angina within the last 6 months.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: First Affiliated Hospital of Chongqing Medical University

Address:
City: Chongqing
Zip: 400014
Country: China

Status: Recruiting

Contact:
Last name: Ming Du, M.D.
Email: Ljdyt1103@sina.com

Facility:
Name: Gansu Provincial Hospital

Address:
City: Lanzhou
Zip: 730000
Country: China

Status: Recruiting

Contact:
Last name: Yun-Jiu Gou, M.D.
Email: gouyunjiu@163.com

Facility:
Name: The Second Hospital of Lanzhou University

Address:
City: Lanzhou
Zip: 730030
Country: China

Status: Recruiting

Contact:
Last name: Bin Li, M.D.
Email: dr.leebin@qq.com

Facility:
Name: Sun Yat-sen University Cancer Center

Address:
City: Guangzhou
Zip: 510060
Country: China

Status: Recruiting

Contact:
Last name: Hao-Xian Yang, M.D.

Phone: +86-020-87343628
Email: yanghx@sysucc.org.cn

Contact backup:
Last name: Mu-Zi Yang, M.D.

Phone: +86-020-87341456
Email: yangmz@sysucc.org.cn

Investigator:
Last name: Hao-Xian Yang, M.D.
Email: Principal Investigator

Facility:
Name: Guangdong Provincial People's Hospital

Address:
City: Guangzhou
Zip: 510080
Country: China

Status: Recruiting

Contact:
Last name: Gui-Bin Qiao, M.D.
Email: guibinqiao@126.com

Facility:
Name: Shenzhen People's Hospital

Address:
City: Shenzhen
Zip: 518020
Country: China

Status: Recruiting

Contact:
Last name: Guang-Suo Wang, M.D.
Email: 908611104@qq.com

Facility:
Name: Shenzhen Third People's Hospital

Address:
City: Shenzhen
Zip: 518112
Country: China

Status: Recruiting

Contact:
Last name: Kun Qiao, M.D.
Email: szqiaokun@163.com

Facility:
Name: The First Affiliated Hospital of Zhengzhou University

Address:
City: Zhengzhou
Zip: 450052
Country: China

Status: Recruiting

Contact:
Last name: Yu Qi, M.D.
Email: qiyu@zzu.edu.cn

Facility:
Name: Wuhan Union Hospital

Address:
City: Wuhan
Zip: 430022
Country: China

Status: Recruiting

Contact:
Last name: Yong-De Liao, M.D.
Email: liaotjxw@126.com

Facility:
Name: Wuhan TongJi Hospital

Address:
City: Wuhan
Zip: 430030
Country: China

Status: Recruiting

Contact:
Last name: Ni Zhang, M.D.
Email: zhangnidoc@vip.163.com

Facility:
Name: The General Hospital of Eastern Theater Command

Address:
City: Nanjing
Zip: 210002
Country: China

Status: Recruiting

Contact:
Last name: Jun Yi, M.D.
Email: 13675101301@163.com

Facility:
Name: Jiangsu Cancer Institute & Hospital

Address:
City: Nanjing
Zip: 210009
Country: China

Status: Recruiting

Contact:
Last name: Ming Li, M.D.
Email: liming750523@163.com

Facility:
Name: Jiangxi Provincial People's Hopital

Address:
City: Nanchang
Zip: 330006
Country: China

Status: Recruiting

Contact:
Last name: Quan Xu, M.D.
Email: xuquan7210@163.com

Facility:
Name: The First Affiliated Hospital of Nanchang University

Address:
City: Nanchang
Zip: 330006
Country: China

Status: Recruiting

Contact:
Last name: Ben-Tong Yu, M.D.
Email: yubentong@126.com

Facility:
Name: Liaoning Tumor Hospital & Institute

Address:
City: Shenyang
Zip: 110042
Country: China

Status: Recruiting

Contact:
Last name: Hong-Xu Liu, M.D.
Email: hongxuliu@qq.com

Facility:
Name: Tang-Du Hospital

Address:
City: Xi'an
Zip: 710038
Country: China

Status: Recruiting

Contact:
Last name: Xiao-Long Yan, M.D.
Email: yxlfmmu@qq.com

Facility:
Name: Qilu Hospital of Shandong University

Address:
City: Jinan
Zip: 250012
Country: China

Status: Recruiting

Contact:
Last name: Hui Tian, M.D.
Email: tianhuiql@126.com

Facility:
Name: Shandong Provincial Hospital

Address:
City: Jinan
Zip: 250022
Country: China

Status: Recruiting

Contact:
Last name: Zhong-Min Peng, M.D.
Email: pengzhm@163.com

Facility:
Name: The Affiliated Hospital of Qingdao University

Address:
City: Qingdao
Zip: 266003
Country: China

Status: Recruiting

Contact:
Last name: Wen-Jie Jiao, M.D.
Email: jiaowj@qduhospital.cn

Facility:
Name: Sichuan Cancer Hospital and Research Institute

Address:
City: Chengdu
Zip: 610041
Country: China

Status: Not yet recruiting

Contact:
Last name: Bin Hu, M.D.
Email: hubin@scszlyy.org.cn

Facility:
Name: West China Hospital

Address:
City: Chengdu
Zip: 610041
Country: China

Status: Recruiting

Contact:
Last name: Yun Wang, M.D.
Email: 2237454336@qq.com

Start date: August 26, 2020

Completion date: December 31, 2029

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Collaborator:
Agency: The First Affiliated Hospital of Nanchang University
Agency class: Other

Collaborator:
Agency: The Affiliated Hospital of Qingdao University
Agency class: Other

Collaborator:
Agency: The General Hospital of Eastern Theater Command
Agency class: Other

Collaborator:
Agency: Gansu Provincial Hospital
Agency class: Other

Collaborator:
Agency: Tang-Du Hospital
Agency class: Other

Collaborator:
Agency: Wuhan TongJi Hospital
Agency class: Other

Collaborator:
Agency: First Affiliated Hospital of Chongqing Medical University
Agency class: Other

Collaborator:
Agency: West China Hospital
Agency class: Other

Collaborator:
Agency: Wuhan Union Hospital, China
Agency class: Other

Collaborator:
Agency: Shenzhen People's Hospital
Agency class: Other

Collaborator:
Agency: The First Affiliated Hospital of Zhengzhou University
Agency class: Other

Collaborator:
Agency: Shandong Provincial Hospital
Agency class: Other

Collaborator:
Agency: Jiangsu Cancer Institute & Hospital
Agency class: Other

Collaborator:
Agency: Guangdong Provincial People's Hospital
Agency class: Other

Collaborator:
Agency: Liaoning Tumor Hospital & Institute
Agency class: Other

Collaborator:
Agency: Qilu Hospital of Shandong University
Agency class: Other

Collaborator:
Agency: Jiangxi Provincial People's Hopital
Agency class: Other

Collaborator:
Agency: Sichuan Cancer Hospital and Research Institute
Agency class: Other

Collaborator:
Agency: Lanzhou University Second Hospital
Agency class: Other

Collaborator:
Agency: Shenzhen Third People's Hospital
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06524427
https://www.chictr.org.cn/bin/project/edit?pid=48784

Login to your account

Did you forget your password?