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Lung Cancer, Non-Small CellNCT06687408

Sleeve Lobectomy for Lung Cancer in Minimally Invasive Surgical Techniques

An observational study of Lung Cancer, Non-Small Cell, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this multicenter observational study is to evaluate the long-term survival and perioperative outcomes of sleeve lobectomy in robotic-assisted thoracic surgery (RATS) for patients with central lung cancer when compared with video-assisted thoracic surgery (VATS) approach, both of which have been already… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Non-Small Cell
What is being tested?
RATS Group and VATS group
Type of treatment
Surgery or procedure
How many people
450 participants
Where
3 sitesChina
Study dates
1 Mar 2025to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study will retrospectively enroll 450 consecutive patients with stage IA~IIIB non-small cell lung cancer performed sleeve lobectomy in minimally invasive surgical techniques (RATS or VATS) from January 2015 to September 2024 in all three related centers. Baseline clinical information, surgery-related data, short-term postoperative outcomes, and long-term survival data (3-year OS and RFS) will be collected and analyzed using the propensity score matching method.

Who may be able to join

  • Age ≥ 18 years;
  • Clinically suspected lung cancer with a high likelihood of undergoing sleeve lobectomy;
  • Postoperative histopathological diagnosis confirms non-small cell lung cancer (NSCLC);
  • No history of malignancy within the past 5 years;
  • Signed informed consent agreeing to participate in this study.

Who cannot join

  • Unable to undergo surgical resection due to surgical contraindications;
  • Postoperative pathology does not confirm non-small cell lung cancer (NSCLC), including but not limited to benign lesions, small cell lung cancer, metastatic tumors, or an insufficient or indeterminate histopathology report;
  • History of malignancy within the past 5 years;
  • Unable to obtain follow-up data;
  • Refusal to sign the informed consent or withdrawal of consent.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Haifeng Shen, M.D. contact

+86 13634197989

shenhaifeng@zju.edu.cn

Junqiang Fan, M.D. contact

+86 13906505607

zrxwk@zju.edu.cn

China3 sites, 3 recruiting
  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009

    Haifeng Shen, M.D., +86 13634197989, shenhaifeng@zju.edu.cn

    Junqiang Fan, M.D., +86 13906505607, zrxwk@zju.edu.cn

    Recruiting
  • Sir Run Run Shaw Hospital, Medical College, Zhejiang University

    Hangzhou, 310016

    Yuhan Zhou, M.D., +86 13656695550, adrianzyh@zju.edu.cn

    Ziyi Zhu, M.D., +86 13588478817, zhuziyicn@zju.edu.cn

    Recruiting
  • Shanghai Chest Hospital, Shanghai Jiao Tong University

    Shanghai, 200030

    Xinghua Cheng, M.D. Ph.D., +86 17701681215, xinhuacheng@sjtu.edu.cn

    Zhebing Lin, M.D., +86 18957727196, lzb871194702@163.com

    Recruiting

Other trials in China

About this study

Official title: Sleeve Lobectomy for Lung Cancer in Minimally Invasive Surgical Techniques: a Multicenter Cohort Study

The goal of this multicenter observational study is to evaluate the long-term survival and perioperative outcomes of sleeve lobectomy in robotic-assisted thoracic surgery (RATS) for patients with central lung cancer when compared with video-assisted thoracic surgery (VATS) approach, both of which have been already applied to these patients in minimally invasive surgical techniques as part of their regular medical care recently. The main question it aims to answer is:

Are RATS sleeve lobectomy associated with similar or even better long-term survival and perioperative outcomes for patients with central lung cancer when compared with the VATS approach?

Read the detailed description

Lung cancer is the leading cause of cancer-related deaths worldwide. Approximately 85% of lung cancer is non-small-cell lung cancer (NSCLC). Nowadays, radical surgery resection remains the recommended local treatment for resectable NSCLC, and bronchial and/or pulmonary artery sleeve lobectomy have been proven to be preferred surgical approaches for patients with centrally located lung cancer when compared with traditional pneumonectomy. The long-term survival and perioperative outcomes of sleeve lobectomy in robotic-assisted thoracic surgery (RATS) and video-assisted thoracic surgery (VATS) for central lung cancer were found to be comparable in a few retrospective studies with a limited number of participants. Still, they have not been investigated in the high-volume cohort setting.

Thus, the investigators conducted the multicenter observational cohort study to investigate if RATS sleeve lobectomy was non-inferior to VATS in patients with centrally located NSCLC and to evaluate the long-term survival and perioperative outcomes of sleeve lobectomy in these two regular minimally invasive surgical techniques.

Participants with centrally located primary NSCLC receiving bronchial sleeve resection with or without pulmonary artery angioplasty in minimally invasive approaches (RATS or VATS) between January 2015 and September 2024 were retrospectively identified and enrolled from the institutional database.

In this study, the investigators will focus on the 3-year overall survival (OS) and recurrence-free survival (RFS) of the patients between the two groups (RATS vs. VATS) for the comparison of the long-term oncologic outcomes in the propensity score matching method. Meanwhile, the perioperative outcomes will be investigated between RATS versus VATS sleeve lobectomy, including but not limited to intraoperative blood loss, operative time, length of hospital stay, postoperative drainage, postoperative complications, perioperative mortality, number of dissected lymph nodes, and margin status. In addition, this study will also try to explore the learning curve for RATS sleeve lobectomy and assess the safety and feasibility of minimally invasive sleeve lobectomy in specific patient populations, such as NSCLC patients following neoadjuvant therapy or those with clinical mediastinal lymph node metastasis. Furthermore, the study is designed to summarize the key surgical techniques and practice skills in minimally invasive thoracic surgery to promote technical improvements.

Being tested
RATS Group, VATS group
Keywords
lung cancer, sleeve lobectomy, minimally invasive thoracic surgery, perioperative outcomes, long-term survival, robotic-assisted thoracic surgery
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RATS GroupProcedure or surgery

    The participants with centrally located lung cancer in this group were performed sleeve lobectomy in robotic-assisted thoracic surgery (RATS) approach, which has been already applied to these patients in minimally invasive surgical techniques as part of their regular medical care recently.

  • VATS groupProcedure or surgery

    The participants with centrally located lung cancer in this group were performed sleeve lobectomy in video-assisted thoracic surgery (VATS) approach.

Study groups in NCT06687408
Study groupRoleWhat they receive
Lung cancer cohort of sleeve lobectomy in minimally invasive surgical approachesThis lung cancer cohort will retrospectively identify and enroll the participants with centrally located primary NSCLC receiving bronchial sleeve resection with or without pulmonary artery angioplasty in minimally invasive approaches (RATS or VATS) between January 2015 and September 2024 from the institutional databases. The choice of minimally invasive surgical approaches depends on the willingness of the surgeons and the participants in this study.
Receives: Procedure: RATS Group; Procedure: VATS group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year RFS

    In this study, the investigators will focus on the 3-year recurrence-free survival (RFS) of the participants between the two groups (RATS vs. VATS) for the comparison of the long-term oncologic outcomes, as the primary outcome.

    Measured: 3 years

Secondary outcomes (1)
  1. 3-year OS

    The investigators will also focus on the 3-year overall survival (OS) of the participants between the two groups (RATS vs. VATS) for the comparison of the long-term oncologic outcomes, as the secondary outcome.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2024
  2. Study start1 Mar 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06687408
Sponsor's protocol ID
2024-0959
Status last verified
Apr 2026
First submitted
8 Nov 2024
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • Qiu T, Zhao Y, Xuan Y, Qin Y, Niu Z, Shen Y, Jiao W. Robotic sleeve lobectomy for centrally located non-small cell lung cancer: A propensity score-weighted comparison with thoracoscopic and open surgery. J Thorac Cardiovasc Surg. 2020 Sep;160(3):838-846.e2. doi: 10.1016/j.jtcvs.2019.10.158. Epub 2019 Nov 22.

    PubMed 31924355
  • Chen T, Zhao W, Ji C, Luo J, Wang Y, Liu Y, Weder W, Fang W. Minimally invasive sleeve lobectomy for centrally located lung cancer: A real-world study with propensity-score matching. Front Oncol. 2023 Feb 1;13:1099514. doi: 10.3389/fonc.2023.1099514. eCollection 2023.

    PubMed 36816921
  • Deng J, Jiang L, Li S, Zhang L, Zhong Y, Xie D, Chen C. The learning curve of video-assisted thoracoscopic sleeve lobectomy in a high-volume pulmonary center. JTCVS Tech. 2021 Jul 20;9:143-152. doi: 10.1016/j.xjtc.2021.07.006. eCollection 2021 Oct.

    PubMed 34647085
  • Pan X, Gu C, Yang J, Shi J. Robotic double-sleeve resection of lung cancer: technical aspects. Eur J Cardiothorac Surg. 2018 Jul 1;54(1):183-184. doi: 10.1093/ejcts/ezy070.

    PubMed 29579169
  • Jiao W, Zhao Y, Qiu T, Xuan Y, Sun X, Qin Y, Liu A, Sui T, Cui J. Robotic Bronchial Sleeve Lobectomy for Central Lung Tumors: Technique and Outcome. Ann Thorac Surg. 2019 Jul;108(1):211-218. doi: 10.1016/j.athoracsur.2019.02.028. Epub 2019 Mar 21.

    PubMed 30904403
  • Cerfolio RJ. Robotic sleeve lobectomy: technical details and early results. J Thorac Dis. 2016 Mar;8(Suppl 2):S223-6. doi: 10.3978/j.issn.2072-1439.2016.01.70. No abstract available.

    PubMed 26981274
  • Gonzalez-Rivas D, Fernandez R, Fieira E, Rellan L. Uniportal video-assisted thoracoscopic bronchial sleeve lobectomy: first report. J Thorac Cardiovasc Surg. 2013 Jun;145(6):1676-7. doi: 10.1016/j.jtcvs.2013.02.052. Epub 2013 Mar 15. No abstract available.

    PubMed 23507125
  • Shen H, Wang X, Nie Y, Zhang K, Wei Z, Yang F, Wang J, Chen K. Minimally invasive surgery versus thoracotomy for resectable stage II and III non-small-cell lung cancers: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2021 May 8;59(5):940-950. doi: 10.1093/ejcts/ezaa437.

    PubMed 33370437
  • Pages PB, Mordant P, Renaud S, Brouchet L, Thomas PA, Dahan M, Bernard A; Epithor Project (French Society of Thoracic and Cardiovascular Surgery). Sleeve lobectomy may provide better outcomes than pneumonectomy for non-small cell lung cancer. A decade in a nationwide study. J Thorac Cardiovasc Surg. 2017 Jan;153(1):184-195.e3. doi: 10.1016/j.jtcvs.2016.09.060. Epub 2016 Oct 13.

    PubMed 27814899
  • Ma Z, Dong A, Fan J, Cheng H. Does sleeve lobectomy concomitant with or without pulmonary artery reconstruction (double sleeve) have favorable results for non-small cell lung cancer compared with pneumonectomy? A meta-analysis. Eur J Cardiothorac Surg. 2007 Jul;32(1):20-8. doi: 10.1016/j.ejcts.2007.03.018. Epub 2007 Apr 17.

    PubMed 17442581
  • Riely GJ, Wood DE, Ettinger DS, Aisner DL, Akerley W, Bauman JR, Bharat A, Bruno DS, Chang JY, Chirieac LR, DeCamp M, Desai AP, Dilling TJ, Dowell J, Durm GA, Gettinger S, Grotz TE, Gubens MA, Juloori A, Lackner RP, Lanuti M, Lin J, Loo BW, Lovly CM, Maldonado F, Massarelli E, Morgensztern D, Mullikin TC, Ng T, Owen D, Owen DH, Patel SP, Patil T, Polanco PM, Riess J, Shapiro TA, Singh AP, Stevenson J, Tam A, Tanvetyanon T, Yanagawa J, Yang SC, Yau E, Gregory KM, Hang L. Non-Small Cell Lung Cancer, Version 4.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2024 May;22(4):249-274. doi: 10.6004/jnccn.2204.0023.

    PubMed 38754467
  • Bender E. Epidemiology: The dominant malignancy. Nature. 2014 Sep 11;513(7517):S2-3. doi: 10.1038/513S2a. No abstract available.

    PubMed 25208070
  • Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108.

    PubMed 35143424
  • Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

    PubMed 38572751

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, Non-Small Cell, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haifeng Shen, M.D. (+86 13634197989, shenhaifeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year RFS (time frame: 3 years). 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 NCT06687408, which also lists 14 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 24 Apr 2026.

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