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Clinical Trial NCT06524427 (RAVAR) for Non Small Cell Lung Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Robot-Assisted vs. Video-Assisted Lobectomy for NSCLC (RAVAR) 1,124 Randomized Short-Term

Recruiting
Clinical Trial NCT06524427 (RAVAR) is an interventional study for Non Small Cell Lung Cancer that is recruiting. It started on 25 August 2020 with plans to enroll 1,124 participants. Led by Sun Yat-sen University, it is expected to complete by 31 December 2030. The latest data from ClinicalTrials.gov was last updated on 31 December 2025.
Brief 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 unsolve...Show More
Official Title

Robot-Assisted Versus Video-Assisted Lobectomy for Non-Small Cell Lung Cancer (RAVAR): A Multicenter, Open-Label, Randomized, Non-Inferiority Trial

Conditions
Non Small Cell Lung Cancer
Other Study IDs
  • RAVAR
  • SL-5010-2019-04
  • ChiCTR2000034737 (Registry Identifier) (Chinese Clinical Trial Registry)
NCT ID Number
NCT06524427
Start Date (Actual)
2020-08-25
Last Update Posted
2025-12-31
Completion Date (Estimated)
2030-12-31
Enrollment (Estimated)
1,124
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Non-small cell lung cancer
Robotic-assisted lobectomy
Video-assisted lobectomy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalRATS group
Patients will receive robot-assisted lobectomy
Robot-assisted lobectomy
Patients will receive robot-assisted lobectomy using Da Vinci surgical system
Active ComparatorVATS group
Patients will receive video-assisted lobectomy
Video-assisted lobectomy
Patients will receive video-assisted lobectomy
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
5-year disease-free survival (DFS)
Difference of 5-year disease free survival rate between the two groups
5 years after surgery
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
5-year overall survival (OS)
Difference of 5-year overall survival rate between the two groups
5 years after surgery
3-year disease-free survival (DFS)
Difference of 3-year disease free survival rate between the two groups
3 years after surgery
3-year overall survival (OS)
Difference of 3-year overall survival rate between the two groups
3 years after surgery
Blood loss
Blood loss during the surgery
During the surgery
Conversion rate
The number of patients converted to thoracotomy divided by the total number of included patients in a group
During the surgery
Perioperative complication
Intraoperative and postoperative complications
The day of surgery, 2/4/8/12/26/52 weeks after surgery
Operative death rate
The number of patients died within 30/90 days after surgery divided by the total number of included patients in a group
30/90 days after surgery
Hospital stays after surgery
The length of stay in hospital after surgery
Between the date of surgery and the date of discharge, assessed up to 30 days
Pain score after surgery
The degree of pain after surgery was measured using Numerical Rating Scale (NRS). The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable). The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours.
Scores were given daily after surgery and at weeks 2/4/8/12/26/52 after discharge
R0 rate
The number of patients received R0 surgery divided by the total number of included patients in a group
Postoperative in-hospital stay up to 30 days
Operative time
The total time from skin to skin and the time of each step were recorded
During the surgery
The number of resected lymph nodes
The number of resected lymph nodes were calculated according to the official pathological report after surgery
Postoperative in-hospital stay up to 30 days
Chest tube duration
The number of days between the date of surgery and the date of chest tube removal
Postoperative in-hospital stay up to 30 days
Acesodyne (Grade III) dose
The total amount of morphine used by the patient during the postoperative hospital stay, including morphine, pethidine, and fentanyl etc.
Postoperative in-hospital stay up to 30 days
Total cost of hospitalization
The total cost of the patient from admission to discharge
From the date of admission to the date of discharge, assessed up to 30 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Age from 18 to 80 years old;
  2. Patients with blood pressure<160/100mmHg, 5.6<blood glucose<11.2mmol/L, major organs function normally: (1) Goldman index between grade 1 and 2; (2) Predicted forced expiratory volume in 1s (FEV1) >= 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.

  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.
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Study Responsible Party
Hao-Xian Yang, Principal Investigator, Principal Investigator, Sun Yat-sen University
Study Central Contact
Contact: Hao-Xian Yang, M.D., +86-020-87343628, [email protected]
Contact: Mu-Zi Yang, M.D., +86-020-87341456, [email protected]
23 Study Locations in 1 Countries

Chongqing Municipality

First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, 400014, China
Ming Du, M.D., Contact, [email protected]
Recruiting

Gansu

Gansu Provincial Hospital, Lanzhou, Gansu, 730000, China
Yun-Jiu Gou, M.D., Contact, [email protected]
Recruiting
The Second Hospital of Lanzhou University, Lanzhou, Gansu, 730030, China
Bin Li, M.D., Contact, [email protected]
Recruiting

Guangdong

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China
Hao-Xian Yang, M.D., Contact, +86-020-87343628, [email protected]
Mu-Zi Yang, M.D., Contact, +86-020-87341456, [email protected]
Hao-Xian Yang, M.D., Principal Investigator
Recruiting
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510080, China
Gui-Bin Qiao, M.D., Contact, [email protected]
Recruiting
Shenzhen People's Hospital, Shenzhen, Guangdong, 518020, China
Guang-Suo Wang, M.D., Contact, [email protected]
Recruiting
Shenzhen Third People's Hospital, Shenzhen, Guangdong, 518112, China
Kun Qiao, M.D., Contact, [email protected]
Recruiting

Guangxi

Guangxi Nanxishan Hospital, Guilin, Guangxi, 541002, China
Rong-Sheng Xiong, M.D., Contact, [email protected]
Recruiting

Henan

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China
Yu Qi, M.D., Contact, [email protected]
Recruiting

Hubei

Wuhan Union Hospital, Wuhan, Hubei, 430022, China
Yong-De Liao, M.D., Contact, [email protected]
Recruiting
Wuhan TongJi Hospital, Wuhan, Hubei, 430030, China
Ni Zhang, M.D., Contact, [email protected]
Recruiting

Jiangsu

The General Hospital of Eastern Theater Command, Nanjing, Jiangsu, 210002, China
Jun Yi, M.D., Contact, [email protected]
Recruiting
Jiangsu Cancer Institute & Hospital, Nanjing, Jiangsu, 210009, China
Ming Li, M.D., Contact, [email protected]
Recruiting

Jiangxi

Jiangxi Provincial People's Hopital, Nanchang, Jiangxi, 330006, China
Quan Xu, M.D., Contact, [email protected]
Recruiting
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China
Ben-Tong Yu, M.D., Contact, [email protected]
Recruiting

Liaoning

Liaoning Tumor Hospital & Institute, Shenyang, Liaoning, 110042, China
Hong-Xu Liu, M.D., Contact, [email protected]
Recruiting

Shaanxi

Tang-Du Hospital, Xi'an, Shaanxi, 710038, China
Xiao-Long Yan, M.D., Contact, [email protected]
Recruiting

Shandong

Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China
Wei-Ming Yue, M.D., Contact, [email protected]
Recruiting
Qianfoshan Hospital, Jinan, Shandong, 250014, China
Hui Tian, M.D., Contact, [email protected]
Recruiting
Shandong Provincial Hospital, Jinan, Shandong, 250022, China
Zhong-Min Peng, M.D., Contact, [email protected]
Recruiting
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266003, China
Wen-Jie Jiao, M.D., Contact, [email protected]
Recruiting

Sichuan

Sichuan Cancer Hospital and Research Institute, Chengdu, Sichuan, 610041, China
Bin Hu, M.D., Contact, [email protected]
Recruiting
West China Hospital, Chengdu, Sichuan, 610041, China
Yun Wang, M.D., Contact, [email protected]
Recruiting