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

Last updated: July 23, 2024
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Robot-assisted lobectomy

Video-assisted lobectomy

Clinical Study ID

NCT06524427
SL-5010-2019-04
ChiCTR2000034737
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 organsfunction normally: (1) Goldman index between grade 1 and 2; (2) Predicted forcedexpiratory volume in 1s (FEV1) >= 40 % and diffusing capacity of the lung for carbonmonoxide (DLCO) >= 40 %; (3) total bilirubin <= 1.5 upper limit of normal; (4)Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) <= 2.5 upper limitof normal; (5) creatinine <= 1.25 upper limit of normal and creatinine clearancerate (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 otherunknown types;

  4. Clinical stage T1-2N0-1 (cI-II): Maximum diameter of tumor <= 5cm and short diameterof 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

Exclusion Criteria:

  1. Patients with radiotherapy, chemotherapy, targeted therapy, or immunotherapy beforesurgery.

  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 oftumor <= 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, myocardialinfarction, or angina within the last 6 months.

Study Design

Total Participants: 1124
Treatment Group(s): 2
Primary Treatment: Robot-assisted lobectomy
Phase:
Study Start date:
August 26, 2020
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 400014
    China

    Active - Recruiting

  • Gansu Provincial Hospital

    Lanzhou, Gansu 730000
    China

    Active - Recruiting

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu 730030
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong 518020
    China

    Active - Recruiting

  • Shenzhen Third People's Hospital

    Shenzhen, Guangdong 518112
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Wuhan TongJi Hospital

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Wuhan Union Hospital

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Jiangsu Cancer Institute & Hospital

    Nanjing, Jiangsu 210009
    China

    Active - Recruiting

  • The General Hospital of Eastern Theater Command

    Nanjing, Jiangsu 210002
    China

    Active - Recruiting

  • Jiangxi Provincial People's Hopital

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Liaoning Tumor Hospital & Institute

    Shenyang, Liaoning 110042
    China

    Active - Recruiting

  • Tang-Du Hospital

    Xi'an, Shaanxi 710038
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong 250022
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266003
    China

    Active - Recruiting

  • Sichuan Cancer Hospital and Research Institute

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

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