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

June 23, 2026 updated by: Zhenguo Sun, Qilu Hospital of Shandong University

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:

  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

274

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhenguo Sun, Doctor of Medicine (MD)
  • Phone Number: +86-185-6008-9136
  • Email: sunzg@sdu.edu.cn

Study Locations

  • China
    • Guizhou
      • Xingyi, Guizhou, China, 562400
        • Xingyi People's Hospital
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750021
        • Ningxia Hui Autonomous Region People's Hospital
        • Contact:
          • Xiaowen Wang, Master of Medicine (M.M.)
          • Phone Number: +86-152-0269-2511
          • Email: 506895970@qq.com
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
        • Contact:
      • Linqing, Shandong, China, 252600
        • Linqing People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

    1. Solid component proportion ≤50%.
    2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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 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.
Active Comparator: 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.
Procedure: 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 sublobar resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraoperatively on day 0.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Complication Rate
Time Frame: 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.
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).
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
Time Frame: From the completion of surgery to chest drainage tube removal, assessed up to 14 days post-surgery.
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
Time Frame: 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.
Postoperative Length of Hospital Stay
Time Frame: From the completion of surgery to hospital discharge, assessed up to 30 days.
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)
Time Frame: 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.
Quality of Life Score (EORTC QLQ-C30)
Time Frame: 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.
Postoperative month 1, month 3, and month 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-2026-03-003-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect participant privacy and maintain clinical data confidentiality, individual participant data will not be made publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Nodule, Solitary

Clinical Trials on Longitude-Latitude-Depth Localization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe