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

NCT ID: NCT06524427

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Non-small cell lung cancer Robotic-assisted lobectomy Video-assisted lobectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RATS group

Patients will receive robot-assisted lobectomy

Group Type EXPERIMENTAL

Robot-assisted lobectomy

Intervention Type PROCEDURE

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

VATS group

Patients will receive video-assisted lobectomy

Group Type ACTIVE_COMPARATOR

Video-assisted lobectomy

Intervention Type PROCEDURE

Patients will receive video-assisted lobectomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robot-assisted lobectomy

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

Intervention Type PROCEDURE

Video-assisted lobectomy

Patients will receive video-assisted lobectomy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

The General Hospital of Eastern Theater Command

OTHER

Sponsor Role collaborator

Gansu Provincial Hospital

OTHER

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role collaborator

Wuhan TongJi Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Shenzhen People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role collaborator

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Jiangxi Provincial People's Hopital

OTHER

Sponsor Role collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role collaborator

Lanzhou University Second Hospital

OTHER

Sponsor Role collaborator

Shenzhen Third People's Hospital

OTHER

Sponsor Role collaborator

Qianfoshan Hospital

OTHER

Sponsor Role collaborator

Guangxi Nanxishan Hospital

UNKNOWN

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hao-Xian Yang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hao-Xian Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Gansu Provincial Hospital

Lanzhou, Gansu, China

Site Status RECRUITING

The Second Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Guangxi Nanxishan Hospital

Guilin, Guangxi, China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Wuhan Union Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Wuhan TongJi Hospital

Wuhan, Hubei, China

Site Status RECRUITING

The General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

Site Status RECRUITING

Jiangsu Cancer Institute & Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Jiangxi Provincial People's Hopital

Nanchang, Jiangxi, China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

Liaoning Tumor Hospital & Institute

Shenyang, Liaoning, China

Site Status RECRUITING

Tang-Du Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Qianfoshan Hospital

Jinan, Shandong, China

Site Status RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status RECRUITING

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, China

Site Status RECRUITING

West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hao-Xian Yang, M.D.

Role: CONTACT

Phone: +86-020-87343628

Email: [email protected]

Mu-Zi Yang, M.D.

Role: CONTACT

Phone: +86-020-87341456

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ming Du, M.D.

Role: primary

Yun-Jiu Gou, M.D.

Role: primary

Bin Li, M.D.

Role: primary

Hao-Xian Yang, M.D.

Role: primary

Mu-Zi Yang, M.D.

Role: backup

Gui-Bin Qiao, M.D.

Role: primary

Guang-Suo Wang, M.D.

Role: primary

Kun Qiao, M.D.

Role: primary

Rong-Sheng Xiong, M.D.

Role: primary

Yu Qi, M.D.

Role: primary

Yong-De Liao, M.D.

Role: primary

Ni Zhang, M.D.

Role: primary

Jun Yi, M.D.

Role: primary

Ming Li, M.D.

Role: primary

Quan Xu, M.D.

Role: primary

Ben-Tong Yu, M.D.

Role: primary

Hong-Xu Liu, M.D.

Role: primary

Xiao-Long Yan, M.D.

Role: primary

Wei-Ming Yue, M.D.

Role: primary

Hui Tian, M.D.

Role: primary

Zhong-Min Peng, M.D.

Role: primary

Wen-Jie Jiao, M.D.

Role: primary

Bin Hu, M.D.

Role: primary

Yun Wang, M.D.

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

https://www.chictr.org.cn/bin/project/edit?pid=48784

This clinical trial has been registered in Chinese Clinical Trial Registry with a registration number as ChiCTR2000034737

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ChiCTR2000034737

Identifier Type: REGISTRY

Identifier Source: secondary_id

SL-5010-2019-04

Identifier Type: -

Identifier Source: org_study_id