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

Официальное название

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

Обзор

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.

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.

Вмешательства

• Процедура Longitude-Latitude-Depth Localization
  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 surfac
• Процедура CT-Guided Percutaneous Lung Puncture Localization
  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 subl

Первичные конечные точки

• Localization Accuracy Rate [Срок оценки: Intraoperatively on day 0.]

Вторичные конечные точки (7)

• Perioperative Complication Rate [Срок оценки: From the initiation of the localization procedure through hospital discharge, up to 14 days post-surgery.]
• Localization Time [Срок оценки: 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 [Срок оценки: From the completion of surgery to chest drainage tube removal, assessed up to 14 days post-surgery.]
• Oxygenation Index [Срок оценки: Postoperative day 1 and day 2.]
• Postoperative Length of Hospital Stay [Срок оценки: From the completion of surgery to hospital discharge, assessed up to 30 days.]
• Postoperative Pain Score (VAS) [Срок оценки: Postoperative day 1, day 2, day 3, and day 7.]
• Quality of Life Score (EORTC QLQ-C30) [Срок оценки: Postoperative month 1, month 3, and month 6.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Xingyi People's Hospital — Xingyi
• Ningxia Hui Autonomous Region People's Hospital — Иньчуань
• Qilu Hospital of Shandong University — Цзинань
• Linqing People's Hospital — Linqing

Публикации

• 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. PMID 39958213
• 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. PMID 10027460
• 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. PMID 35116651
• 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. PMID 33717587
• 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. PMID 32953501
• 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. PMID 27717643
• 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. PMID 33687468

Идентификаторы

NCT: NCT07675889 · KYLL-2026-03-003-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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