Pulmonary Nodule, SolitaryNCT07675889
Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules
A study testing Longitude-Latitude-Depth Localization and CT-Guided Percutaneous Lung Puncture Localization in people with Pulmonary Nodule, Solitary and Peripheral Pulmonary Nodules, run by Qilu Hospital of Shandong University at 4 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Nodule, Solitary, Peripheral Pulmonary Nodules, Pulmonary Nodules
- What is being tested?
- Longitude-Latitude-Depth Localization and CT-Guided Percutaneous Lung Puncture Localization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Zhenguo Sun, MD, +86-186-6008-9136, sunzg@sdu.edu.cn
- Recruiting
Linqing People's Hospital
Linqing, Shandong, 252600
Tao Hei, B.S.Med, +86-199-6355-9051, 1720361716@qq.com
- Recruiting
Xingyi People's Hospital
Xingyi, Guizhou, 562400
Renzhong Cha, B.S.Med, +86-19185939543, zharenzhong@163.com
- Recruiting
Ningxia Hui Autonomous Region People's Hospital
Yinchuan, Ningxia, 750021
Xiaowen Wang, Master of Medicine (M.M.), +86-152-0269-2511, 506895970@qq.com
About this study
Official title: 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?
Read more
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.
Read the detailed description
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.
- Being tested
- Longitude-Latitude-Depth Localization, CT-Guided Percutaneous Lung Puncture Localization
- Keywords
- Peripheral Pulmonary Nodule, Pulmonary Nodule Localization, Longitude-Latitude-Depth Localization, CT-Guided Percutaneous Localization, Video-Assisted Thoracoscopic Surgery, Sublobar Resection, Randomized Controlled Trial, Non-Inferiority Trial
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitude-Latitude-Depth LocalizationProcedure or surgery
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.
CT-Guided Percutaneous Lung Puncture LocalizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Longitude-Latitude-Depth Localization |
| 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. Receives: Procedure: CT-Guided Percutaneous Lung Puncture Localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperatively on day 0.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative month 1, month 3, and month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jul 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenguo Sun, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675889
- Sponsor's protocol ID
- KYLL-2026-03-003-1
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant privacy and maintain clinical data confidentiality, individual participant data will not be made publicly available.
Publications
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.
PubMed 39958213Suzuki 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.
PubMed 10027460Zhang 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.
PubMed 35116651Zhou 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.
PubMed 33717587Qiu 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.
PubMed 32953501Park 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.
PubMed 27717643Jonas 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.
PubMed 33687468
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07675889
- Acronym / sponsor ID
- KYLL-2026-03-003-1
- Keywords
- Peripheral Pulmonary Nodule, Pulmonary Nodule Localization, Longitude-Latitude-Depth Localization, CT-Guided Percutaneous Localization, Video-Assisted Thoracoscopic Surgery, Sublobar Resection, Randomized Controlled Trial, Non-Inferiority Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Longitude-Latitude-Depth Localization Group | Experimental | Procedure: Longitude-Latitude-Depth LocalizationParticipants 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. |
| CT-Guided Percutaneous Lung Puncture Localization Group | Active comparator | Procedure: CT-Guided Percutaneous Lung Puncture LocalizationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Longitude-Latitude-Depth LocalizationThe 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. | Procedure or surgery | Longitude-Latitude-Depth Localization Group |
| CT-Guided Percutaneous Lung Puncture LocalizationCT-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. | Procedure or surgery | CT-Guided Percutaneous Lung Puncture Localization Group |
Primary outcome
Localization Accuracy Rate
Time frame: 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.
7 secondary outcomes
Perioperative Complication Rate
Time frame: From the initiation of the localization procedure through hospital discharge, up to 14 days post-surgery.
Localization Time
Time frame: 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
Time frame: From the completion of surgery to chest drainage tube removal, assessed up to 14 days post-surgery.
Oxygenation Index
Time frame: Postoperative day 1 and day 2.
Postoperative Length of Hospital Stay
Time frame: From the completion of surgery to hospital discharge, assessed up to 30 days.
Postoperative Pain Score (VAS)
Time frame: Postoperative day 1, day 2, day 3, and day 7.
Quality of Life Score (EORTC QLQ-C30)
Time frame: Postoperative month 1, month 3, and month 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 39958213Zhao 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.
- Background: PubMed 10027460Suzuki 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.
- Background: PubMed 35116651Zhang 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.
- Background: PubMed 33717587Zhou 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.
- Background: PubMed 32953501Qiu 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.
- Background: PubMed 27717643Park 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.
- Background: PubMed 33687468Jonas 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.
- Individual participant dataSharing planned: No. To protect participant privacy and maintain clinical data confidentiality, individual participant data will not be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Longitude-Latitude-Depth Localization and CT-Guided Percutaneous Lung Puncture Localization in people with Pulmonary Nodule, Solitary and Peripheral Pulmonary Nodules, run by Qilu Hospital of Shandong University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenguo Sun, Doctor of Medicine (MD) (+86-185-6008-9136, sunzg@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Localization Accuracy Rate (time frame: Intraoperatively on day 0.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07675889, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.