Cardiorespiratory Fitness After Lobectomy Versus Sublobar Resection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTongji Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Lobectomy

    Procedure/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 Resection

    Procedure/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.

Treatment groups

604 Participants
are divided into 2 treatment groups
Group A: Lobectomy1 intervention
Group B: Sublobar Resection1 intervention

Trial outcomes

Primary outcomes

1

Change in peak oxygen uptake (peak VO2)

Time frame
Baseline and at 6 and 12 months after surgery
2

Change in maximum oxygen uptake per kilogram of body weight

Time frame
Baseline and at 6 and 12 months after surgery
3

Change in maximum oxygen uptake as a percentage of the predicted value

Time frame
Baseline and at 6 and 12 months after surgery
4

Change in anaerobic threshold (AT)

Time frame
Baseline and at 6 and 12 months after surgery

Secondary outcomes

1

Change in forced vital capacity (FVC)

Time frame
Baseline and at 6 and 12 months after surgery
2

Change in forced expiratory volume in one second (FEV1)

Time frame
Baseline and at 6 and 12 months after surgery
3

Change in the FEV1/FVC ratio

Time frame
Baseline and at 6 and 12 months after surgery
4

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

Other outcomes

Sponsors and contacts

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