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NCT Number: NCT07436598

3D Virtual Resection for Predicting Lung Function in VATS

This study aims to validate a novel preoperative assessment strategy using three-dimensional (3-D) computed tomography (CT) reconstruction and virtual resection simulation. The goal is to accurately predict postoperative pulmonary function in patients with non-small cell lung cancer (NSCLC) undergoing Video-Assisted Thoracoscopic Surgery (VATS) anatomical resection.

Accurate prediction of postoperative lung function is crucial for patient safety. Traditional methods, such as segment counting, often lack precision because they assume all lung segments contribute equally to function, ignoring variations caused by tumors or emphysema. This study utilizes 3-D "virtual resection" to quantify the "Planned Resected Ventilated Lung Volume Fraction" (pRVLVF) before surgery.

The study will recruit 60 participants divided into two groups: those undergoing lobectomy (n=30) and those undergoing segmentectomy (n=30). Participants will undergo standard thin-slice CT scans and pulmonary function tests (PFT) before surgery. Postoperatively, lung function and recovery will be tracked at 3, 6, and 12 months to develop a dynamic prediction model and evaluate the compensatory capacity of the residual lung.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Cancer Center

Taipei, Taiwan

Location status: Recruiting

About this study

Background: Lung cancer remains a leading cause of cancer mortality. For early-stage NSCLC, VATS anatomical resection (lobectomy or segmentectomy) is the standard treatment. However, the safety of surgery depends heavily on the patient's pulmonary reserve. Traditional prediction methods, such as the segment-counting rule, have shown prediction errors of up to 20-30% because they do not account for regional heterogeneity in lung ventilation.

Study Design: This is a prospective, multi-center, longitudinal cohort study. The study intends to enroll 60 patients eligible for VATS anatomical resection. Patients will be stratified into two groups:

  • VATS Segmentectomy Group (n=30)
  • VATS Lobectomy Group (n=30)

Methodology:

1.Preoperative Assessment: Within 30 days before surgery, all participants will undergo high-resolution thin-slice (1 mm) chest CT and standard Pulmonary Function Tests (PFT).

2.3-D Virtual Resection: Using Synapse 3-D software, a patient-specific anatomical model will be reconstructed. The investigator will perform a "virtual resection" simulation to mark the planned resection area. The system will calculate the Planned Resected Ventilated Lung Volume Fraction (pRVLVF), defined based on well-aerated lung tissue (CT attenuation -950 to -700 HU).

3.Surgical Procedure: Patients will undergo standard VATS lobectomy or segmentectomy as clinically indicated.

4.Postoperative Follow-up: PFTs will be performed at 3, 6, and 12 months post-surgery. Follow-up CT scans will be performed at 6 and 12 months to assess structural remodeling.

Objectives and Analysis:

Primary Objective: To validate the accuracy of the pRVLVF-based prediction model. The primary endpoint is the Mean Absolute Error (MAE) of the predicted FEV1 at 3 months post-surgery, with a target accuracy of MAE < 180 mL.

Secondary Objectives:

  • To assess long-term prediction accuracy at 6 and 12 months.
  • To quantify the "Compensation Coefficient" (CC) of the residual lung using Linear Mixed-Effects (LME) models, adjusting for age, BMI, and smoking history.
  • To evaluate the impact of postoperative complications on the functional recovery curve.

This study seeks to establish a precise, accessible, and dynamic tool for surgical risk assessment and decision-making in thoracic surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for video-assisted thoracoscopic (VATS) lobectomy or segmentectomy at National Taiwan University Hospital or NTU Cancer Center.
  • Age between 18 and 80 years.
  • Patients who have signed the informed consent form agreeing to provide imaging data for 3D modeling.

Exclusion criteria

  • Age younger than 18 or older than 80 years.
  • Patients not scheduled for VATS lobectomy or segmentectomy.
  • Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
  • Patients unable or unwilling to sign the informed consent form.
  • Vulnerable populations.

Treatment and study plan

Primary outcomes

  1. Mean Absolute Error (MAE) of Predicted Postoperative FEV1

    Time frame: 3 months post-operation

    The accuracy of the preoperative 3D virtual resection model will be evaluated by calculating the Mean Absolute Error (MAE) between the predicted FEV1 and the actual measured FEV1. A lower MAE indicates higher prediction accuracy. The study targets an MAE of less than 180 mL.

Secondary outcomes

  1. Long-term Prediction Error of FEV1 and FVC

    Time frame: 6 months and 12 months post-operation

    Evaluation of the prediction model's accuracy at 6 and 12 months to assess stability over time.

Study contacts

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

Chih-Hsiang Chang, MD

CONTACT

[email protected]

+886-0972653384

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Preoperative Three-Dimensional Virtual Resection Predicts Postoperative Pulmonary Function After Anatomical Resection : A Prospective Longitudinal Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
May 13, 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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