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

December 25, 2025 updated by: Hao-Xian Yang, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400014
        • Recruiting
        • First Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • Gansu Provincial Hospital
        • Contact:
      • Lanzhou, Gansu, China, 730030
        • Recruiting
        • The Second Hospital of Lanzhou University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hao-Xian Yang, M.D.
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518020
        • Recruiting
        • ShenZhen People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518112
        • Recruiting
        • Shenzhen Third People's Hospital
        • Contact:
    • Guangxi
      • Guilin, Guangxi, China, 541002
        • Recruiting
        • Guangxi Nanxishan Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The first affiliated hospital of Zhengzhou university
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital
        • Contact:
      • Wuhan, Hubei, China, 430030
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
      • Nanjing, Jiangsu, China, 210002
        • Recruiting
        • The General Hospital of Eastern Theater Command
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • Jiangxi Provincial People's Hopital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Recruiting
        • Liaoning Tumor Hospital & Institute
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Recruiting
        • Tang-Du Hospital
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China, 250022
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
      • Jinan, Shandong, China, 250014
      • Qingdao, Shandong, China, 266003
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Sichuan Cancer Hospital and Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RATS group
Patients will receive robot-assisted lobectomy
Procedure: Robot-assisted lobectomy
Patients will receive robot-assisted lobectomy using Da Vinci surgical system
Active Comparator: VATS group
Patients will receive video-assisted lobectomy
Procedure: Video-assisted lobectomy
Patients will receive video-assisted lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year disease-free survival (DFS)
Time Frame: 5 years after surgery
Difference of 5-year disease free survival rate between the two groups
5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: During the surgery
Blood loss during the surgery
During the surgery
5-year overall survival (OS)
Time Frame: 5 years after surgery
Difference of 5-year overall survival rate between the two groups
5 years after surgery
3-year disease-free survival (DFS)
Time Frame: 3 years after surgery
Difference of 3-year disease free survival rate between the two groups
3 years after surgery
3-year overall survival (OS)
Time Frame: 3 years after surgery
Difference of 3-year overall survival rate between the two groups
3 years after surgery
Conversion rate
Time Frame: During the surgery
The number of patients converted to thoracotomy divided by the total number of included patients in a group
During the surgery
Perioperative complication
Time Frame: The day of surgery, 2/4/8/12/26/52 weeks after surgery
Intraoperative and postoperative complications
The day of surgery, 2/4/8/12/26/52 weeks after surgery
Operative death rate
Time Frame: 30/90 days after surgery
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
Time Frame: Between the date of surgery and the date of discharge, assessed up to 30 days
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
Time Frame: Scores were given daily after surgery and at weeks 2/4/8/12/26/52 after discharge
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
Time Frame: Postoperative in-hospital stay up to 30 days
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
Time Frame: During the surgery
The total time from skin to skin and the time of each step were recorded
During the surgery
The number of resected lymph nodes
Time Frame: Postoperative in-hospital stay up to 30 days
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
Time Frame: Postoperative in-hospital stay up to 30 days
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
Time Frame: Postoperative in-hospital stay up to 30 days
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
Time Frame: From the date of admission to the date of discharge, assessed up to 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

The First Affiliated Hospital of Nanchang University
West China Hospital
Qilu Hospital of Shandong University
The Affiliated Hospital of Qingdao University
Shandong Provincial Hospital
The First Affiliated Hospital of Zhengzhou University
Guangdong Provincial People's Hospital
Jiangsu Cancer Institute & Hospital
Shenzhen People's Hospital
Gansu Provincial Hospital
Qianfoshan Hospital
Tang-Du Hospital
First Affiliated Hospital of Chongqing Medical University
Wuhan TongJi Hospital
Sichuan Cancer Hospital and Research Institute
Guangxi Nanxishan Hospital
Jiangxi Provincial People's Hopital
Shenzhen Third People's Hospital
The General Hospital of Eastern Theater Command
Lanzhou University Second Hospital
Liaoning Cancer Hospital & Institute
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Investigators

  • Principal Investigator: Hao-Xian Yang, M.D., Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 25, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL-5010-2019-04
  • ChiCTR2000034737 (Registry Identifier: Chinese Clinical Trial Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Small Cell Lung Cancer

Clinical Trials on Robot-assisted lobectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe