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NCT Number: NCT06687408

Sleeve Lobectomy for Lung Cancer in Minimally Invasive Surgical Techniques

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sir Run Run Shaw Hospital, Medical College, Zhejiang University, Hangzhou, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

VATS group

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Haifeng Shen, M.D.

CONTACT

[email protected]

+86 13634197989

Junqiang Fan, M.D.

CONTACT

[email protected]

+86 13906505607

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 13, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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