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临床试验/NCT07436598
NCT07436598招募中不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

National Taiwan University Clinical Trial Center

Professor, Department of Surgery

National Taiwan University Hospital

研究点 (1)

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