Lung Cancer (NSCLC)NCT07841249
Cardiorespiratory Fitness After Lobectomy Versus Sublobar Resection
An observational study of Lung Cancer (NSCLC), run by Tongji Hospital at 1 site in China.
Trial summary
This observational study will compare changes in cardiorespiratory fitness after lobectomy and sublobar resection. Sublobar resection includes segmentectomy and wedge resection. Patients who can undergo pulmonary resection and meet the eligibility criteria will be studied during routine clinical care; the research… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Lobectomy and Sublobar Resection
- Type of treatment
- Surgery or procedure
- How many people
- 604 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled to undergo pulmonary resection at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, will be screened for participation. Eligible patients are those who are considered able to tolerate surgical treatment, including lobectomy, segmentectomy, or wedge resection, based on routine preoperative cardiopulmonary evaluation. Participants will undergo cardiopulmonary exercise testing and pulmonary function assessment before surgery and will be followed at 6 and 12 months after surgery. Study cohorts will be defined according to the extent of pulmonary resection received: lobectomy or sublobar resection.
Who may be able to join
- 1. Able to understand the study and provide written informed consent. 2. Considered able to tolerate surgical treatment, including segmentectomy, lobectomy, or wedge resection, following preoperative assessment, including cardiac and pulmonary function testing.
- -
Who cannot join
- Pregnant or breastfeeding.
- Any absolute contraindication to CPET.
- A history of severe heart disease, heart failure, myocardial infarction, or an episode of angina within the previous 3 months.
- A cerebrovascular event, including cerebral infarction or cerebral hemorrhage, within the previous 3 months.
- A psychiatric illness that prevents communication.
- Unable to cooperate with the examinations. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Wei Ping, 8613437101581, pingwei@tjh.tjmu.edu.cn
About this study
Official title: Impact of Lobectomy Versus Sublobar Resection on Cardiorespiratory Fitness: An Observational Study Based on Cardiopulmonary Exercise Testing
This observational study will compare changes in cardiorespiratory fitness after lobectomy and sublobar resection. Sublobar resection includes segmentectomy and wedge resection. Patients who can undergo pulmonary resection and meet the eligibility criteria will be studied during routine clinical care; the research will not assign the surgical procedure or add a study-specific intervention.
Cardiopulmonary exercise testing (CPET) and pulmonary function testing will be performed before surgery and at routine follow-up visits 6 and 12 months after surgery. Changes from the preoperative assessment will be compared within each surgical group and between the two groups. The study will also examine the relationship between CPET measurements and postoperative complications.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Lobectomy, Sublobar Resection
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LobectomyProcedure or surgery
Anatomic resection of an entire pulmonary lobe. The procedure may be performed via open thoracotomy or minimally invasive approaches, including video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracoscopic surgery (RATS). The surgical approach and technique are determined by the treating surgeon according to routine clinical practice, tumor characteristics, patient anatomy, and pulmonary function. No randomization or study-specific intervention is assigned by the research protocol.
Sublobar ResectionProcedure or surgery
Lung-preserving resection including segmentectomy and wedge resection. Segmentectomy is an anatomic resection of one or more bronchopulmonary segments. Wedge resection is a non-anatomic resection of lung parenchyma containing the lesion, typically with a wedge-shaped margin. The procedure may be performed via open thoracotomy or minimally invasive approaches, including VATS or RATS. The specific surgical procedure and approach are determined by the treating surgeon according to routine clinical practice, tumor characteristics, patient anatomy, and pulmonary function. No randomization or study-specific intervention is assigned by the research protocol.
| Study group | Role | What they receive |
|---|---|---|
| Lobectomy | Not described Receives: Procedure: Lobectomy | |
| Sublobar Resection | Not described Receives: Procedure: Sublobar Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen uptake (peak VO2)
Measured: Baseline and at 6 and 12 months after surgery
Change in maximum oxygen uptake per kilogram of body weight
Measured: Baseline and at 6 and 12 months after surgery
Change in maximum oxygen uptake as a percentage of the predicted value
Measured: Baseline and at 6 and 12 months after surgery
Change in anaerobic threshold (AT)
Measured: Baseline and at 6 and 12 months after surgery
Secondary outcomes (5)
Change in forced vital capacity (FVC)
Measured: Baseline and at 6 and 12 months after surgery
Change in forced expiratory volume in one second (FEV1)
Measured: Baseline and at 6 and 12 months after surgery
Change in the FEV1/FVC ratio
Measured: Baseline and at 6 and 12 months after surgery
Change in Lung Volume and Lung Volume as a Percentage of the Preoperative Value
Measured: Baseline and at 6 and 12 months after surgery
Incidence of postoperative complications
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Aug 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 604 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Ni, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841249
- Sponsor's protocol ID
- TJ-IRB20220753
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lobectomy Versus Sublobar Resection on Cardiorespiratory Fitness: An Observational Study Based on Cardiopulmonary Exercise Testing
- ClinicalTrials.gov ID
- NCT07841249
- Acronym / sponsor ID
- TJ-IRB20220753
- Conditions
- Lung Cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 604 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study will compare changes in cardiorespiratory fitness after lobectomy and sublobar resection. Sublobar resection includes segmentectomy and wedge resection. Patients who can undergo pulmonary resection and meet the eligibility criteria will be studied during routine clinical care; the research will not assign the surgical procedure or add a study-specific intervention.
Cardiopulmonary exercise testing (CPET) and pulmonary function testing will be performed before surgery and at routine follow-up visits 6 and 12 months after surgery. Changes from the preoperative assessment will be compared within each surgical group and between the two groups. The study will also examine the relationship between CPET measurements and postoperative complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lobectomy | – | Procedure: Lobectomy |
| Sublobar Resection | – | Procedure: Sublobar Resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled to undergo pulmonary resection at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, will be screened for participation. Eligible patients are those who are considered able to tolerate surgical treatment, including lobectomy, segmentectomy, or wedge resection, based on routine preoperative cardiopulmonary evaluation. Participants will undergo cardiopulmonary exercise testing and pulmonary function assessment before surgery and will be followed at 6 and 12 months after surgery. Study cohorts will be defined according to the extent of pulmonary resection received: lobectomy or sublobar resection.
Key inclusion criteria (2 listed)
- 1. Able to understand the study and provide written informed consent. 2. Considered able to tolerate surgical treatment, including segmentectomy, lobectomy, or wedge resection, following preoperative assessment, including cardiac and pulmonary function testing.
- -
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding.
- Any absolute contraindication to CPET.
- A history of severe heart disease, heart failure, myocardial infarction, or an episode of angina within the previous 3 months.
- A cerebrovascular event, including cerebral infarction or cerebral hemorrhage, within the previous 3 months.
- A psychiatric illness that prevents communication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LobectomyAnatomic resection of an entire pulmonary lobe. The procedure may be performed via open thoracotomy or minimally invasive approaches, including video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracoscopic surgery (RATS). The surgical approach and technique are determined by the treating surgeon according to routine clinical practice, tumor characteristics, patient anatomy, and pulmonary function. No randomization or study-specific intervention is assigned by the research protocol. | Procedure or surgery | Lobectomy |
| Sublobar ResectionLung-preserving resection including segmentectomy and wedge resection. Segmentectomy is an anatomic resection of one or more bronchopulmonary segments. Wedge resection is a non-anatomic resection of lung parenchyma containing the lesion, typically with a wedge-shaped margin. The procedure may be performed via open thoracotomy or minimally invasive approaches, including VATS or RATS. The specific surgical procedure and approach are determined by the treating surgeon according to routine clinical practice, tumor characteristics, patient anatomy, and pulmonary function. No randomization or study-specific intervention is assigned by the research protocol. | Procedure or surgery | Sublobar Resection |
Primary outcome
Change in peak oxygen uptake (peak VO2)
Time frame: Baseline and at 6 and 12 months after surgery
Change in maximum oxygen uptake per kilogram of body weight
Time frame: Baseline and at 6 and 12 months after surgery
Change in maximum oxygen uptake as a percentage of the predicted value
Time frame: Baseline and at 6 and 12 months after surgery
Change in anaerobic threshold (AT)
Time frame: Baseline and at 6 and 12 months after surgery
5 secondary outcomes
Change in forced vital capacity (FVC)
Time frame: Baseline and at 6 and 12 months after surgery
Change in forced expiratory volume in one second (FEV1)
Time frame: Baseline and at 6 and 12 months after surgery
Change in the FEV1/FVC ratio
Time frame: Baseline and at 6 and 12 months after surgery
Change in Lung Volume and Lung Volume as a Percentage of the Preoperative Value
Time frame: Baseline and at 6 and 12 months after surgery
Incidence of postoperative complications
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (NSCLC), run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Ping (8613437101581, pingwei@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak oxygen uptake (peak VO2) (time frame: Baseline and at 6 and 12 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.