Sleeve Lobectomy for Lung Cancer in Minimally Invasive Surgical Techniques

April 21, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Junqiang Fan, M.D.
  • Phone Number: +86 13906505607
  • Email: zrxwk@zju.edu.cn

Study Locations

  • China
      • Hangzhou, China, 310009
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Haifeng Shen, M.D.
      • Hangzhou, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital, Medical College, Zhejiang University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yuhan Zhou, M.D.
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital, Shanghai Jiao Tong University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Xinghua Cheng, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year RFS
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year OS
Time Frame: 3 years
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.
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: up to 90 days
The intraoperative blood loss will be investigated between RATS versus VATS sleeve lobectomy as one of the perioperative outcomes, measured in milliliter (mL).
up to 90 days
Operative time
Time Frame: up to 90 days
The operative time will be investigated between RATS versus VATS sleeve lobectomy as one of the perioperative outcomes, measured in minute (min).
up to 90 days
Length of hospital stay
Time Frame: up to 90 days
The length of hospital stay will be investigated between RATS versus VATS sleeve lobectomy as one of the perioperative outcomes, measured in day.
up to 90 days
Postoperative drainage
Time Frame: up to 90 days
The postoperative drainage will be investigated between RATS versus VATS sleeve lobectomy as one of the perioperative outcomes, measured in milliliter (mL).
up to 90 days
Postoperative complications
Time Frame: up to 90 days
The postoperative complications will be investigated between RATS versus VATS sleeve lobectomy as one of the perioperative outcomes, showed in the number of the participants who occurred postoperative complications (n).
up to 90 days
Perioperative mortality
Time Frame: up to 90 days
The perioperative mortality will be investigated between RATS versus VATS sleeve lobectomy as one of the perioperative outcomes, showed in the number of the participants who died within 90 days of surgery (n).
up to 90 days
Number of dissected lymph nodes
Time Frame: up to 90 days
The number of dissected lymph nodes will be investigated between RATS versus VATS sleeve lobectomy as one of the perioperative outcomes (n).
up to 90 days
Margin status
Time Frame: up to 90 days
The margin status will be investigated between RATS versus VATS sleeve lobectomy as one of the perioperative outcomes, showed in the number of the participants who had the positive or negative surgical margins (n).
up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Sir Run Run Shaw Hospital
Shanghai Chest Hospital of Shanghai Jiao Tong University

Investigators

  • Principal Investigator: Haifeng Shen, M.D., Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Study Director: Xinghua Cheng, M.D. Ph.D., Shanghai Chest Hospital of Shanghai Jiao Tong University
  • Study Chair: Junqiang Fan, M.D., Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Study Director: Yuhan Zhou, M.D., Sir Run Run Shaw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 8, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0959

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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