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Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules

2026年9月27日 更新者:Zhenguo Sun、Qilu Hospital of Shandong University

Intraoperative Longitude-Latitude-Depth Three-Dimensional Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for the Treatment of 0.8-2 cm Peripheral Pulmonary Nodules: A Multicenter, Randomized, Open-Label, Non-Inferiority Clinical Trial

The goal of this clinical trial is to learn whether intraoperative longitude-latitude-depth three-dimensional localization (LLD localization) is non-inferior to preoperative CT-guided percutaneous lung puncture localization for identifying 0.8-2 cm peripheral pulmonary nodules in adults undergoing video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection. It will also evaluate the safety and perioperative effectiveness of the two localization methods. The main questions it aims to answer are:

  1. Is the localization accuracy rate of LLD localization non-inferior to that of CT-guided percutaneous lung puncture localization?
  2. Does LLD localization improve perioperative outcomes, including localization time, postoperative recovery, pain, quality of life, and perioperative complication rates?

Researchers will compare LLD localization with CT-guided percutaneous lung puncture localization to determine whether LLD localization provides comparable localization accuracy while reducing procedure-related complications and improving perioperative outcomes.

Participants will:

  1. Be randomly assigned in a 1:1 ratio to either the LLD localization group or the CT-guided percutaneous lung puncture localization group.
  2. Undergo pulmonary nodule localization using the assigned localization method.
  3. Receive VATS-assisted sublobar resection following localization.
  4. Be assessed for localization accuracy, perioperative complications, localization time, postoperative chest drainage tube removal time, oxygenation index, postoperative hospital stay, pain scores, and quality-of-life outcomes.
  5. Complete follow-up assessments at 1, 3, and 6 months after surgery.

研究概览

详细说明

Peripheral pulmonary nodules, particularly small subsolid nodules, are increasingly detected due to the widespread use of low-dose computed tomography (CT) screening. Accurate intraoperative identification of these nodules remains challenging during video-assisted thoracoscopic surgery because many lesions are difficult to visualize or palpate after lung collapse. Reliable localization is therefore essential to facilitate precise sublobar resection while preserving healthy lung tissue.

Preoperative CT-guided percutaneous localization techniques are widely used in clinical practice. However, these procedures require additional preoperative intervention and may be associated with complications such as pneumothorax, pulmonary hemorrhage, hemothorax, patient discomfort, and increased procedural complexity. Furthermore, successful localization depends on radiologic resources and coordination between multiple departments.

The longitude-latitude-depth (LLD) localization method is a novel intraoperative three-dimensional localization strategy developed to identify pulmonary nodules using anatomical reference lines and preoperative imaging measurements. The method utilizes the natural longitudinal and transverse landmarks of the collapsed lung together with the measured depth of the target lesion to estimate the spatial location of the nodule during surgery. Because localization is performed intraoperatively without transcutaneous puncture, the technique has the potential to reduce procedure-related trauma and simplify the clinical workflow.

Preliminary clinical experience suggests that the LLD localization method may provide accurate localization while avoiding several limitations associated with preoperative puncture-based approaches. However, high-quality prospective evidence comparing this technique with current standard localization methods remains limited.

This multicenter randomized controlled trial has been designed to provide rigorous clinical evidence regarding the performance of the LLD localization technique. The study will evaluate whether this novel approach can serve as an effective alternative to conventional CT-guided localization and support broader clinical application in the surgical management of peripheral pulmonary nodules.

研究类型

介入性

注册 (估计的)

274

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Zhenguo Sun, Doctor of Medicine (MD)
  • 电话号码:+86-185-6008-9136
  • 邮箱:sunzg@sdu.edu.cn

学习地点

    • Guizhou
      • Xingyi、Guizhou、中国、562400
        • 招聘中
        • Xingyi People's Hospital
        • 接触:
    • Ningxia
      • Yinchuan、Ningxia、中国、750021
        • 招聘中
        • Ningxia Hui Autonomous Region People's Hospital
        • 接触:
          • Xiaowen Wang, Master of Medicine (M.M.)
          • 电话号码:+86-152-0269-2511
          • 邮箱:506895970@qq.com
    • Shandong
      • Jinan、Shandong、中国、250012
        • 招聘中
        • Qilu Hospital of Shandong University
        • 接触:
      • Linqing、Shandong、中国、252600
        • 招聘中
        • Linqing People's Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Clinically diagnosed pulmonary nodule by non-contrast chest CT.

  • Age 18 to 80 years.

  • Expected survival time of at least 12 months.

  • Single peripheral pulmonary nodule with a diameter between 0.8 cm and 2 cm.

  • Chest CT characteristics meeting both of the following criteria:

    1. Solid component proportion ≤50%.
    2. Located subpleurally or in the outer one-third of the lung parenchyma.
  • Willing to undergo VATS-assisted sublobar resection.

  • No contraindications to pulmonary localization procedures or surgery.

  • Able to understand the study and willing to sign written informed consent.

Exclusion Criteria:

  • Use of other localization methods or other surgical procedures.
  • Concurrent participation in another clinical study.
  • Pregnancy.
  • Unwillingness or inability to cooperate with participation in this study for any reason.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Longitude-Latitude-Depth Localization Group

Participants assigned to this arm will undergo intraoperative longitude-latitude-depth (LLD) localization of peripheral pulmonary nodules. The localization method uses anatomical reference lines and preoperative imaging measurements to determine the three-dimensional position of the target nodule during surgery. Following localization, participants will undergo video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection according to standard surgical practice.

The longitude-latitude-depth (LLD) localization method is a novel intraoperative three-dimensional pulmonary nodule localization technique developed for peripheral pulmonary nodules. Based on preoperative computed tomography (CT) imaging, the target lesion is characterized according to its longitudinal position, transverse position, and depth relative to the visceral pleural surface. During surgery, corresponding anatomical landmarks on the collapsed lung are identified, and the projected surface location and lesion depth are used to estimate the three-dimensional position of the target nodule. Localization is performed intraoperatively without preoperative transcutaneous puncture or placement of localization materials. The identified localization point is subsequently used to guide video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection of the target lesion.

有源比较器:CT-Guided Percutaneous Lung Puncture Localization Group

Participants assigned to this arm will undergo preoperative CT-guided percutaneous pulmonary nodule localization according to institutional standard practice. Following localization, participants will undergo video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection according to standard surgical practice.

CT-guided percutaneous lung puncture localization is a preoperative localization procedure performed under computed tomography guidance. A localization device is inserted through the chest wall into the lung parenchyma to mark the location of the target pulmonary nodule before surgery. Following localization, the position of the marker relative to the nodule is confirmed by CT imaging. The localization result is subsequently used to guide video-assisted thoracoscopic surgery (VATS)-assisted sublobar resection.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Localization Accuracy Rate
大体时间:Intraoperatively on day 0.

Localization accuracy rate is defined as the percentage of participants with successful localization, calculated as (number of successfully localized participants / total number of participants) × 100%. Localization is deemed successful if the actual distance between the localization point and the true nodule center, or its surface projection, is 1 cm or less. A distance exceeding 1 cm is classified as localization failure.

After removal of the pulmonary nodule, measure the distance from the nodule center to the marked localization point with a ruler and record the value.

Intraoperatively on day 0.

次要结果测量

结果测量
措施说明
大体时间
Perioperative Complication Rate
大体时间:From the initiation of the localization procedure through hospital discharge, up to 14 days post-surgery.

The perioperative complication rate is defined as the proportion of participants experiencing one or more procedure-related or surgery-related complications during the perioperative period. Complications include, but are not limited to, pneumothorax, hemothorax, pulmonary hemorrhage, hemoptysis, prolonged air leak, and other adverse events requiring medical intervention.

From the initiation of the localization procedure through hospital discharge, up to 14 days post-surgery.
Localization Time
大体时间:During the localization procedure on day 0 (from the start of localization to its confirmed completion, approximately 5-20 minutes).

Localization time is defined as the time required to complete the pulmonary nodule localization procedure. For the LLD group, localization time is measured from initiation of intraoperative localization to successful identification of the localization point. For the CT-guided localization group, localization time is measured from initiation of the CT-guided localization procedure to completion of localization confirmation. The outcome will be reported in minutes.

During the localization procedure on day 0 (from the start of localization to its confirmed completion, approximately 5-20 minutes).
Postoperative Chest Drainage Tube Removal Time
大体时间:From the completion of surgery to chest drainage tube removal, assessed up to 14 days post-surgery.

Chest drainage tube removal time is defined as the interval between completion of surgery and removal of the postoperative chest drainage tube according to institutional postoperative management criteria. The outcome will be reported in days. A shorter duration indicates faster postoperative recovery.

From the completion of surgery to chest drainage tube removal, assessed up to 14 days post-surgery.
Oxygenation Index
大体时间:Postoperative day 1 and day 2.

The oxygenation index is calculated as the ratio of arterial oxygen partial pressure (PaO₂) to the fraction of inspired oxygen (FiO₂). Higher values indicate better pulmonary oxygenation function. The outcome will be reported as the PaO₂/FiO₂ ratio measured from arterial blood gas analysis.

Postoperative day 1 and day 2.
Postoperative Length of Hospital Stay
大体时间:From the completion of surgery to hospital discharge, assessed up to 30 days.

Postoperative length of hospital stay is defined as the number of days from completion of surgery until hospital discharge. The outcome will be reported in days. A shorter hospital stay indicates faster postoperative recovery and resource utilization efficiency.

From the completion of surgery to hospital discharge, assessed up to 30 days.
Postoperative Pain Score (VAS)
大体时间:Postoperative day 1, day 2, day 3, and day 7.

The Visual Analogue Scale (VAS) is used to assess postoperative pain intensity. Participants rate their pain on a scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity. The outcome will be reported as the mean VAS score at each assessment time point.

Postoperative day 1, day 2, day 3, and day 7.
Quality of Life Score (EORTC QLQ-C30)
大体时间:Postoperative month 1, month 3, and month 6.

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) is used to assess health-related quality of life. The questionnaire includes functional scales, symptom scales, and a global health status scale. Scores are transformed to a 0-100 scale according to the EORTC scoring manual. For functional scales and global health status, higher scores indicate better functioning and quality of life. For symptom scales, higher scores indicate greater symptom burden and worse quality of life.

Postoperative month 1, month 3, and month 6.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月1日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2026年6月23日

首先提交符合 QC 标准的

2026年6月23日

首次发布 (实际的)

2026年6月30日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月27日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

To protect participant privacy and maintain clinical data confidentiality, individual participant data will not be made publicly available.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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