Sleeve Lobectomy for Lung Cancer in Minimally Invasive Surgical Techniques

NCT06687408 | Recruiting DMC

• 1 other identifier: 2024-0959
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 3

Brief 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 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?

Conditions

Lung Cancer, Non-Small Cell

Keywords

lung cancer; sleeve lobectomy; minimally invasive thoracic surgery; perioperative outcomes; long-term survival; robotic-assisted thoracic surgery

Outcome Measures

Primary Outcomes (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.

  3 years

Secondary Outcomes (1)

• 3-year OS

  3 years

Other Outcomes (8)

• Intraoperative blood loss

  up to 90 days

• Operative time

  up to 90 days

• Length of hospital stay

  up to 90 days

Study Arms (1)

Lung cancer cohort of sleeve lobectomy in minimally invasive surgical approaches

This 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.

Procedure: RATS Group; Procedure: VATS group

Interventions

RATS Group PROCEDURE

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.

Lung cancer cohort of sleeve lobectomy in minimally invasive surgical approaches

VATS group PROCEDURE

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

Lung cancer cohort of sleeve lobectomy in minimally invasive surgical approaches

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Shanghai Chest Hospital of Shanghai Jiao Tong University: collaborator
• Sir Run Run Shaw Hospital: collaborator

Study Sites (3)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, 310009, China

RECRUITING

Sir Run Run Shaw Hospital, Medical College, Zhejiang University

Hangzhou, 310016, China

RECRUITING

Shanghai Chest Hospital, Shanghai Jiao Tong University

Shanghai, 200030, China

RECRUITING

Related Publications (14)

• 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.

  PMID: 31924355 RESULT

• 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.

  PMID: 36816921 RESULT

• 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.

  PMID: 34647085 RESULT

• 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.

  PMID: 29579169 RESULT

• 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.

  PMID: 30904403 RESULT

• 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.

  PMID: 26981274 RESULT

• 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.

  PMID: 23507125 RESULT

• 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.

  PMID: 33370437 RESULT

• 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.

  PMID: 27814899 RESULT

• 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.

  PMID: 17442581 RESULT

• 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.

  PMID: 38754467 RESULT

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

  PMID: 25208070 RESULT

• 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.

  PMID: 35143424 RESULT

• 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.

  PMID: 38572751 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Haifeng Shen, M.D.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Xinghua Cheng, M.D. Ph.D.

  Shanghai Chest Hospital of Shanghai Jiao Tong University

  STUDY DIRECTOR

• Yuhan Zhou, M.D.

  Sir Run Run Shaw Hospital

  STUDY DIRECTOR

• Junqiang Fan, M.D.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Haifeng Shen, M.D.

CONTACT

+86 13634197989; shenhaifeng@zju.edu.cn

Junqiang Fan, M.D.

CONTACT

+86 13906505607; zrxwk@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 13, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)