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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Longitude-Latitude-Depth Localization Group | Experimental | 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. |
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| CT-Guided Percutaneous Lung Puncture Localization Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Longitude-Latitude-Depth Localization | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Localization Accuracy Rate | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Complication Rate | 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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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenguo Sun, Doctor of Medicine (MD) | Contact | +86-185-6008-9136 | sunzg@sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xingyi People's Hospital | Xingyi | Guizhou | 562400 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39958213 | Background | 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. | |
| 10027460 | Background | 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. |
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To protect participant privacy and maintain clinical data confidentiality, individual participant data will not be made publicly available.
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Participants will be randomly assigned in a 1:1 ratio to either the intraoperative longitude-latitude-depth (LLD) localization group or the preoperative CT-guided percutaneous localization group. This is a multicenter, open-label, parallel-group, non-inferiority trial designed to evaluate whether LLD localization provides non-inferior localization accuracy compared with conventional CT-guided localization for peripheral pulmonary nodules.
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| CT-Guided Percutaneous Lung Puncture Localization | Procedure | 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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| From the initiation of the localization procedure through hospital discharge, up to 14 days post-surgery. |
| Localization Time | 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 | 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 | 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 | 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) | 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) | 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. |
| Ningxia Hui Autonomous Region People's Hospital | Yinchuan | Ningxia | 750021 | China |
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| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
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| Linqing People's Hospital | Linqing | Shandong | 252600 | China |
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| 35116651 | Background | 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. |
| 33717587 | Background | 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. |
| 32953501 | Background | 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. |
| 27717643 | Background | 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. |
| 33687468 | Background | 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. |
| ID | Term |
|---|---|
| D003074 | Solitary Pulmonary Nodule |
| D055613 | Multiple Pulmonary Nodules |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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