Pulmonary NeoplasmRVlobNCT03134534
Robot-assisted vs VATS Lobectomy for NSCLC
A study testing VATS lobectomy and RATS lobectomy in people with Pulmonary Neoplasm, run by Ruijin Hospital at 1 site in China.
Trial summary
Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial, the purpose of this study is to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Neoplasm
- What is being tested?
- VATS lobectomy and RATS lobectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgical indication for lobectomy;
- minimal invasive surgery;
- ASA (American Society of Anesthesiologists) stage: I-III;
- sign the informed consent. -
Who cannot join
- benign tumor or nodule;
- present of other malignancy;
- preoperative chemotherapy, radiotherapy, targeted therapy. -
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 021
About this study
Official title: The Study of Robotic-assisted Thoracoscopic Lobectomy Versus Video-assisted Thoracoscopic Lobectomy for Non-small Cell Lung Cancer (RVlob)
Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial, the purpose of this study is to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.
Read the detailed description
Video-assisted thoracoscopic surgery (VATS) lobectomy is recommended for non small cell lung cancer (NSCLC) with surgical indications in China, its oncological long-term outcomes has been widely approved. As a new form of VATS, robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the 3D vision and flexible robot arm were helpful for surgeons to perform precise operations, and RATS was reported to bring extra benefits to patients. The surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. so we designed this randomized controlled trial to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.
- Conditions
- Pulmonary Neoplasm
- Being tested
- VATS lobectomy, RATS lobectomy
- Keywords
- lobectomy, robot-assisted thoracoscopic surgery, lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS lobectomyProcedure or surgery
a minimal invasive surgical types for NSCLC: VATS lobectomy
RATS lobectomyProcedure or surgery
a minimal invasive surgical types for NSCLC: RATS lobectomy
| Study group | Role | What they receive |
|---|---|---|
| VATS group | Other | Surgical procedure: VATS lobectomy Receives: Procedure: VATS lobectomy |
| RATS group | Other | Surgical procedure: RATS lobectomy Receives: Procedure: RATS lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival (OS)
OS at 3 year after surgery
Measured: 3 year after surgery
Lymph node counts
overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station
Measured: postoperative in-hospital stay up to 30 days
Secondary outcomes (13)
3-year disease-free survival (DFS)
DFS at 3 year after surgery
Measured: 3 year after surgery
1-year overall survival (OS)
OS at 1 year after surgery
Measured: 1 year after surgery
1-year disease-free survival (DFS)
DFS at 1 year after surgery
Measured: 1 year after surgery
R0 rate
R0 radical rate
Measured: postoperative in-hospital stay up to 30 days
margin state
positive margin rate
Measured: postoperative in-hospital stay up to 30 days
operative time
the time of operation
Measured: postoperative in-hospital stay up to 30 days
blood loss
blood loss in the operation
Measured: postoperative in-hospital stay up to 30 days
conversion rate
the rate of conversion to open surgery in the operation
Measured: postoperative in-hospital stay up to 30 days
operative accident event
the accident event happened in operative
Measured: postoperative in-hospital stay up to 30 days
30-day mortality
30-day mortality after surgery
Measured: postoperative in-hospital stay up to 30 days
length of stay (LOS)
length of stay in hospitalization
Measured: postoperative in-hospital stay up to 30 days
postoperative complications
mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Measured: postoperative in-hospital stay up to 30 days
quality of life (QOL) at 3 month
QOL, WHOQOL-BREF
Measured: at 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 Jun 2017
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary NeoplasmStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hecheng Li M.D., Ph.D, Ruijin Hospital
- Investigators
- He-Cheng Li, doctor, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134534
- Sponsor's protocol ID
- RTS-002
- Acronym
- RVlob
- Status last verified
- Oct 2023
- First submitted
- 15 Apr 2017
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li C, Chen X, Wang X, Guo W, Zhang Y, Chen F, Li H. Single-Port Robotic-Assisted Approach in Thoracic Surgery: A Prospective Real-World Study. Interdiscip Cardiovasc Thorac Surg. 2025 Jul 3;40(7):ivaf161. doi: 10.1093/icvts/ivaf161.
PubMed 40658465Niu Z, Cao Y, Du M, Sun S, Yan Y, Zheng Y, Han Y, Zhang X, Zhang Z, Yuan Y, Li J, Zhang Y, Li C, Han D, Du H, Guo W, Chen K, Xiang J, Zhu L, Che J, Hang J, Ren J, Lerut T, Abbas AE, Lin J, Jin R, Li H. Robotic-assisted versus video-assisted lobectomy for resectable non-small-cell lung cancer: the RVlob randomized controlled trial. EClinicalMedicine. 2024 Jul 12;74:102707. doi: 10.1016/j.eclinm.2024.102707. eCollection 2024 Aug.
PubMed 39105193Jin R, Zhang Z, Zheng Y, Niu Z, Sun S, Cao Y, Zhang Y, Abbas AE, Lerut T, Lin J, Li H. Health-Related Quality of Life Following Robotic-Assisted or Video-Assisted Lobectomy in Patients With Non-Small Cell Lung Cancer: Results From the RVlob Randomized Clinical Trial. Chest. 2023 Jun;163(6):1576-1588. doi: 10.1016/j.chest.2022.12.037. Epub 2023 Jan 5.
PubMed 36621757Jin R, Zheng Y, Yuan Y, Han D, Cao Y, Zhang Y, Li C, Xiang J, Zhang Z, Niu Z, Lerut T, Lin J, Abbas AE, Pardolesi A, Suda T, Amore D, Schraag S, Aigner C, Li J, Che J, Hang J, Ren J, Zhu L, Li H. Robotic-assisted Versus Video-assisted Thoracoscopic Lobectomy: Short-term Results of a Randomized Clinical Trial (RVlob Trial). Ann Surg. 2022 Feb 1;275(2):295-302. doi: 10.1097/SLA.0000000000004922.
PubMed 33938492
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Robotic-assisted Thoracoscopic Lobectomy Versus Video-assisted Thoracoscopic Lobectomy for Non-small Cell Lung Cancer (RVlob)
- ClinicalTrials.gov ID
- NCT03134534
- Acronym / sponsor ID
- RVlob / RTS-002
- Conditions
- Pulmonary Neoplasm
- Keywords
- lobectomy, robot-assisted thoracoscopic surgery, lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial, the purpose of this study is to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.
Detailed description
Video-assisted thoracoscopic surgery (VATS) lobectomy is recommended for non small cell lung cancer (NSCLC) with surgical indications in China, its oncological long-term outcomes has been widely approved. As a new form of VATS, robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the 3D vision and flexible robot arm were helpful for surgeons to perform precise operations, and RATS was reported to bring extra benefits to patients. The surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. so we designed this randomized controlled trial to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VATS group | Other | Procedure: VATS lobectomySurgical procedure: VATS lobectomy |
| RATS group | Other | Procedure: RATS lobectomySurgical procedure: RATS lobectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- surgical indication for lobectomy;
- minimal invasive surgery;
- ASA (American Society of Anesthesiologists) stage: I-III;
- sign the informed consent. -
Key exclusion criteria (3 listed)
- benign tumor or nodule;
- present of other malignancy;
- preoperative chemotherapy, radiotherapy, targeted therapy. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VATS lobectomya minimal invasive surgical types for NSCLC: VATS lobectomy | Procedure or surgery | VATS group |
| RATS lobectomya minimal invasive surgical types for NSCLC: RATS lobectomy | Procedure or surgery | RATS group |
Primary outcome
3-year overall survival (OS)
Time frame: 3 year after surgery
OS at 3 year after surgery
Lymph node counts
Time frame: postoperative in-hospital stay up to 30 days
overall lymph node counts, number of stations dissected, and number of lymph nodes in each lymph node station
13 secondary outcomes
3-year disease-free survival (DFS)
Time frame: 3 year after surgery
1-year overall survival (OS)
Time frame: 1 year after surgery
1-year disease-free survival (DFS)
Time frame: 1 year after surgery
R0 rate
Time frame: postoperative in-hospital stay up to 30 days
margin state
Time frame: postoperative in-hospital stay up to 30 days
operative time
Time frame: postoperative in-hospital stay up to 30 days
blood loss
Time frame: postoperative in-hospital stay up to 30 days
conversion rate
Time frame: postoperative in-hospital stay up to 30 days
operative accident event
Time frame: postoperative in-hospital stay up to 30 days
30-day mortality
Time frame: postoperative in-hospital stay up to 30 days
length of stay (LOS)
Time frame: postoperative in-hospital stay up to 30 days
postoperative complications
Time frame: postoperative in-hospital stay up to 30 days
quality of life (QOL) at 3 month
Time frame: at 3 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 40658465Li C, Chen X, Wang X, Guo W, Zhang Y, Chen F, Li H. Single-Port Robotic-Assisted Approach in Thoracic Surgery: A Prospective Real-World Study. Interdiscip Cardiovasc Thorac Surg. 2025 Jul 3;40(7):ivaf161. doi: 10.1093/icvts/ivaf161.
- Derived from this study: PubMed 39105193Niu Z, Cao Y, Du M, Sun S, Yan Y, Zheng Y, Han Y, Zhang X, Zhang Z, Yuan Y, Li J, Zhang Y, Li C, Han D, Du H, Guo W, Chen K, Xiang J, Zhu L, Che J, Hang J, Ren J, Lerut T, Abbas AE, Lin J, Jin R, Li H. Robotic-assisted versus video-assisted lobectomy for resectable non-small-cell lung cancer: the RVlob randomized controlled trial. EClinicalMedicine. 2024 Jul 12;74:102707. doi: 10.1016/j.eclinm.2024.102707. eCollection 2024 Aug.
- Derived from this study: PubMed 36621757Jin R, Zhang Z, Zheng Y, Niu Z, Sun S, Cao Y, Zhang Y, Abbas AE, Lerut T, Lin J, Li H. Health-Related Quality of Life Following Robotic-Assisted or Video-Assisted Lobectomy in Patients With Non-Small Cell Lung Cancer: Results From the RVlob Randomized Clinical Trial. Chest. 2023 Jun;163(6):1576-1588. doi: 10.1016/j.chest.2022.12.037. Epub 2023 Jan 5.
- Derived from this study: PubMed 33938492Jin R, Zheng Y, Yuan Y, Han D, Cao Y, Zhang Y, Li C, Xiang J, Zhang Z, Niu Z, Lerut T, Lin J, Abbas AE, Pardolesi A, Suda T, Amore D, Schraag S, Aigner C, Li J, Che J, Hang J, Ren J, Zhu L, Li H. Robotic-assisted Versus Video-assisted Thoracoscopic Lobectomy: Short-term Results of a Randomized Clinical Trial (RVlob Trial). Ann Surg. 2022 Feb 1;275(2):295-302. doi: 10.1097/SLA.0000000000004922.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
He-Cheng Li, doctor principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VATS lobectomy and RATS lobectomy in people with Pulmonary Neoplasm, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival (OS) (time frame: 3 year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03134534, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.