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NCT Number: NCT06524427

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 to 80 years old;
  • 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;
  • The first clinical diagnosis before surgery was non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other unknown types;
  • Clinical stage T1-2N0-1 (cI-II): Maximum diameter of tumor <= 5cm and short diameter of mediastinal lymph node <= 1cm in thin layer CT;
  • Performance status of Eastern Cooperative Oncology Group (ECOG) 0-1;
  • All relevant examinations were completed within 28 days before the operation;
  • Patients who understand this study and have signed an approved Informed Consent.

Exclusion criteria

  • Patients with radiotherapy, chemotherapy, targeted therapy, or immunotherapy before surgery.
  • Patients with the previous history of other malignancies;
  • Patients with secondary primary cancer when enrolled;
  • Patients diagnosed as pure ground glass opacity (GGO) before surgery;
  • Patients diagnosed as mixed GGO whose solid part <= 50% and Maximum diameter of tumor <= 2cm;
  • Patients with small cell lung cancer;
  • Patients with prior unilateral open thoracic surgical procedures;
  • Woman who is pregnant or breastfeeding;
  • Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema;
  • Patients with an active bacterial or fungal infection that is difficult to control;
  • Patients with serious psychosis;
  • Patients with a history of severe heart attack, heart failure, myocardial infarction, or angina within the last 6 months.

Treatment and study plan

Robot-assisted lobectomy

Procedure

Patients will receive robot-assisted lobectomy using Da Vinci surgical system

Video-assisted lobectomy

Procedure

Patients will receive video-assisted lobectomy

Primary outcomes

  1. 5-year disease-free survival (DFS)

    Time frame: 5 years after surgery

    Difference of 5-year disease free survival rate between the two groups

Secondary outcomes

  1. 5-year overall survival (OS)

    Time frame: 5 years after surgery

    Difference of 5-year overall survival rate between the two groups

  2. 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. 3-year overall survival (OS)

    Time frame: 3 years after surgery

    Difference of 3-year overall survival rate between the two groups

  4. Blood loss

    Time frame: During the surgery

    Blood loss during the surgery

  5. 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

  6. Perioperative complication

    Time frame: The day of surgery, 2/4/8/12/26/52 weeks after surgery

    Intraoperative and postoperative complications

  7. 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

  8. 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

  9. 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.

  10. 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

  11. Operative time

    Time frame: During the surgery

    The total time from skin to skin and the time of each step were recorded

  12. 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

  13. 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

  14. 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.

  15. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hao-Xian Yang, M.D.

CONTACT

[email protected]

+86-020-87343628

Mu-Zi Yang, M.D.

CONTACT

[email protected]

+86-020-87341456

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: RAVAR

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jul 29, 2024
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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