3D Virtual Resection for Predicting Lung Function in VATS

May 10, 2026 updated by: National Taiwan University Clinical Trial Center, National Taiwan University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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:

  1. VATS Segmentectomy Group (n=30)
  2. 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:

  1. To assess long-term prediction accuracy at 6 and 12 months.
  2. To quantify the "Compensation Coefficient" (CC) of the residual lung using Linear Mixed-Effects (LME) models, adjusting for age, BMI, and smoking history.
  3. 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.

Study Type

Observational

Enrollment (Estimated)

60

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 Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Cancer Center

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

Patients with non-small cell lung cancer recruited from the thoracic surgery outpatient clinics and inpatient wards of National Taiwan University Hospital.

Description

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.

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
VATS Segmentectomy Group
Patients with non-small cell lung cancer scheduled to undergo video-assisted thoracoscopic segmentectomy.
VATS Lobectomy Group
Patients with non-small cell lung cancer scheduled to undergo video-assisted thoracoscopic lobectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months and 12 months post-operation

Collaborators and Investigators

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

Sponsor

National Taiwan University 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)

April 7, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

February 22, 2026

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202510086RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Lung Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe