Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules
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:
- Is the localization accuracy rate of LLD localization non-inferior to that of CT-guided percutaneous lung puncture localization?
- 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:
- Be randomly assigned in a 1:1 ratio to either the LLD localization group or the CT-guided percutaneous lung puncture localization group.
- Undergo pulmonary nodule localization using the assigned localization method.
- Receive VATS-assisted sublobar resection following localization.
- 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.
- Complete follow-up assessments at 1, 3, and 6 months after surgery.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Zhenguo Sun, Doctor of Medicine (MD)
- Номер телефона: +86-185-6008-9136
- Электронная почта: sunzg@sdu.edu.cn
Места учебы
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Guizhou
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Xingyi, Guizhou, Китай, 562400
- Xingyi People's Hospital
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Контакт:
- Renzhong Cha, B.S.Med
- Номер телефона: +86-19185939543
- Электронная почта: zharenzhong@163.com
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Ningxia
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Yinchuan, Ningxia, Китай, 750021
- Ningxia Hui Autonomous Region People's Hospital
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Контакт:
- Xiaowen Wang, Master of Medicine (M.M.)
- Номер телефона: +86-152-0269-2511
- Электронная почта: 506895970@qq.com
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Shandong
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Jinan, Shandong, Китай, 250012
- Qilu Hospital of Shandong University
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Контакт:
- Zhenguo Sun, MD
- Номер телефона: +86-186-6008-9136
- Электронная почта: sunzg@sdu.edu.cn
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Linqing, Shandong, Китай, 252600
- Linqing People's Hospital
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Контакт:
- Tao Hei, B.S.Med
- Номер телефона: +86-199-6355-9051
- Электронная почта: 1720361716@qq.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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:
- Solid component proportion ≤50%.
- 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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
|
|
Активный компаратор: 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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Localization Accuracy Rate
Временное ограничение: 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.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Perioperative Complication Rate
Временное ограничение: 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.
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From the initiation of the localization procedure through hospital discharge, up to 14 days post-surgery.
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Localization Time
Временное ограничение: 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).
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Postoperative Chest Drainage Tube Removal Time
Временное ограничение: From the completion of surgery to chest drainage tube removal, assessed up to 14 days post-surgery.
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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.
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From the completion of surgery to chest drainage tube removal, assessed up to 14 days post-surgery.
|
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Oxygenation Index
Временное ограничение: 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.
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Postoperative Length of Hospital Stay
Временное ограничение: From the completion of surgery to hospital discharge, assessed up to 30 days.
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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)
Временное ограничение: 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.
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Quality of Life Score (EORTC QLQ-C30)
Временное ограничение: 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.
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Postoperative month 1, month 3, and month 6.
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Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- Park CH, Han K, Hur J, Lee SM, Lee JW, Hwang SH, Seo JS, Lee KH, Kwon W, Kim TH, Choi BW. Comparative Effectiveness and Safety of Preoperative Lung Localization for Pulmonary Nodules: A Systematic Review and Meta-analysis. Chest. 2017 Feb;151(2):316-328. doi: 10.1016/j.chest.2016.09.017. Epub 2016 Oct 4.
- Suzuki K, Nagai K, Yoshida J, Ohmatsu H, Takahashi K, Nishimura M, Nishiwaki Y. Video-assisted thoracoscopic surgery for small indeterminate pulmonary nodules: indications for preoperative marking. Chest. 1999 Feb;115(2):563-8. doi: 10.1378/chest.115.2.563.
- Qiu B, Ji Y, He H, Zhao J, Xue Q, Gao S. Three-dimensional reconstruction/personalized three-dimensional printed model for thoracoscopic anatomical partial-lobectomy in stage I lung cancer: a retrospective study. Transl Lung Cancer Res. 2020 Aug;9(4):1235-1246. doi: 10.21037/tlcr-20-571.
- Zhao Y, Qiu J, Bright A, Zhao R, Li R, Tang Z, Yue W, Tian H, Sun Z. Intraoperative longitude-latitude-depth three-dimensional localization of pulmonary nodules. Transl Lung Cancer Res. 2025 Jan 24;14(1):260-271. doi: 10.21037/tlcr-2024-1170. Epub 2025 Jan 22.
- Zhang B, Zhang Y, Le H, Li W, Chen C, Fang R, Pan X. Intraoperative localization in minimally invasive surgery for small pulmonary nodules: a retrospective study. Transl Cancer Res. 2021 Jul;10(7):3470-3478. doi: 10.21037/tcr-21-1059.
- Zhou C, Li X, Li W, Qian J. Clock dial integrated positioning combined with single utility port video-assisted thoracoscopic surgery: a new localization method for lung tumors. J Thorac Dis. 2021 Feb;13(2):1143-1150. doi: 10.21037/jtd-20-3312.
- Jonas DE, Reuland DS, Reddy SM, Nagle M, Clark SD, Weber RP, Enyioha C, Malo TL, Brenner AT, Armstrong C, Coker-Schwimmer M, Middleton JC, Voisin C, Harris RP. Screening for Lung Cancer With Low-Dose Computed Tomography: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2021 Mar 9;325(10):971-987. doi: 10.1001/jama.2021.0377.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KYLL-2026-03-003-1
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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