Sleeve Lobectomy for Lung Cancer in Minimally Invasive Surgical Techniques

Official title

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

Overview

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?

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.

Interventions

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

Primary outcome measures

• 3-year RFS [Time frame: 3 years]

Secondary outcome measures (1)

• 3-year OS [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 3 centers

• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou
• Sir Run Run Shaw Hospital, Medical College, Zhejiang University — Hangzhou
• Shanghai Chest Hospital, Shanghai Jiao Tong University — Shanghai

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 33370437

Identifiers

NCT: NCT06687408 · 2024-0959

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗