Clinical trial NCT06687408: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer, Non-Small Cell
Keywords: lung cancer
sleeve lobectomy
minimally invasive thoracic surgery
perioperative outcomes
long-term survival
robotic-assisted thoracic surgery
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shanghai Chest Hospital of Shanghai Jiao Tong University
name: Sir Run Run Shaw Hospital
First posted: 2024-11-13
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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?

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.

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.

Primary outcomes:
measure: 3-year RFS
timeFrame: 3 years
Secondary outcomes:
measure: 3-year OS
timeFrame: 3 years
Other outcomes:
measure: Intraoperative blood loss
timeFrame: up to 90 days
measure: Operative time
timeFrame: up to 90 days
measure: Length of hospital stay
timeFrame: up to 90 days
measure: Postoperative drainage
timeFrame: up to 90 days
measure: Postoperative complications
timeFrame: up to 90 days
measure: Perioperative mortality
timeFrame: up to 90 days
measure: Number of dissected lymph nodes
timeFrame: up to 90 days
measure: Margin status
timeFrame: up to 90 days
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Medical College, Zhejiang University
city: Shanghai
country: China
facility: Shanghai Chest Hospital, Shanghai Jiao Tong University
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Haifeng Shen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Chest Hospital of Shanghai Jiao Tong University
name: Xinghua Cheng, M.D. Ph.D.
role: STUDY_DIRECTOR
affiliation: Sir Run Run Shaw Hospital
name: Yuhan Zhou, M.D.
role: STUDY_DIRECTOR
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Junqiang Fan, M.D.
role: STUDY_CHAIR
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