National Taiwan University Cancer Center
Taipei, Taiwan
Location status: Recruiting
NCT Number: NCT07436598
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Taipei, Taiwan
Location status: Recruiting
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:
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:
This study seeks to establish a precise, accessible, and dynamic tool for surgical risk assessment and decision-making in thoracic surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
Preoperative Three-Dimensional Virtual Resection Predicts Postoperative Pulmonary Function After Anatomical Resection : A Prospective Longitudinal Study
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.
Published trials that share one or more normalized conditions with this study.
NCT00413283
Blood Platelet Disorders, Bronchial Neoplasms
Glendale, Arizona, United States
View Trial DetailsNCT07489066
Bronchial Neoplasms, Carcinoma
Hinsdale, Illinois, United States
View Trial DetailsNCT07222566
Advanced Non-Small Cell Lung Cancer, Bronchial Neoplasms
Bullhead City, Arizona, United States
View Trial DetailsNCT04585750
Adnexal Diseases, Advanced Malignant Neoplasm
Irvine, California, United States
View Trial Details