An interventional study of Longitude-Latitude-Depth Localization and CT-Guided Percutaneous Lung Puncture Localization in Pulmonary Nodule, Solitary, Peripheral Pulmonary Nodules and Pulmonary Nodules, sponsored by Qilu Hospital of Shandong University. Recruiting at 4 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment
Among 26 studies in Solitary Pulmonary Nodule with a site in China — 5 open to participants now, 7 under way, none of them phase 3. Solitary Pulmonary Nodule · China.
Among the 26 studies in Solitary Pulmonary Nodule with a site in China, this one is the 4th largest by planned enrollment of the 13 interventional ones, is the only one that started in 2026, is one of 12 with no phase, and was the 26th registered.
93 studies on the registry are indexed under Solitary Pulmonary Nodule; 20 are open to participants now.
This study's planned enrollment of 274 is above the median of 81 across 44 interventional studies indexed under Solitary Pulmonary Nodule.
Browse Solitary Pulmonary Nodule studies →5 of the 26 studies in Solitary Pulmonary Nodule with a site in China are open now, in 1 country. Each count lists the studies.
Of the 12 Solitary Pulmonary Nodule studies recruiting now, 6 (50%) set no upper age limit and 1 (8%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 1 started in 2026.
Median enrollment 81 across the 13 interventional studies, 500 across the 13 observational. Of the 11 that completed or were terminated, 3 (27%) have results posted.
3 of 26 have an industry lead sponsor. The 10 most frequent:
Qilu Hospital of Shandong University is the lead sponsor of 310 studies on the registry; 188 are open to participants now.
Qilu Hospital of Shandong University has 1 study filed under Solitary Pulmonary Nodule — fewer than ten, so there is no comparison to draw.
1 of the studies in Solitary Pulmonary Nodule with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06518655ChromX HealthDifferentiation of Benign and Malignant Pulmonary Nodules by Volatile Organic Compounds in Human Exhaled Breath | 2026-12-30 |
Among the 26 studies in Solitary Pulmonary Nodule with a site in China, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Chest CT characteristics meeting both of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Longitude-Latitude-Depth Localization
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.
Procedure: CT-Guided Percutaneous Lung Puncture 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 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 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.
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.
Time frame: Intraoperatively on day 0.
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Postoperative month 1, month 3, and month 6.
Plan to share: No — To protect participant privacy and maintain clinical data confidentiality, individual participant data will not be made publicly available.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2028, 24 months after the start.
Of 24 interventional studies with no phase under Solitary Pulmonary Nodule, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 24 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Qilu Hospital of Shandong University →