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

NCT07675889 | Not Yet Recruiting

• 1 other identifier: KYLL-2026-03-003-1
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 4

Brief 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 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. 1.Is the localization accuracy rate of LLD localization non-inferior to that of CT-guided percutaneous lung puncture localization?
2. 2.Does LLD localization improve perioperative outcomes, including localization time, postoperative recovery, pain, quality of life, and perioperative complication rates?
3. 3.Be randomly assigned in a 1:1 ratio to either the LLD localization group or the CT-guided percutaneous lung puncture localization group.
4. 4.Undergo pulmonary nodule localization using the assigned localization method.
5. 5.Receive VATS-assisted sublobar resection following localization.
6. 6.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.
7. 7.Complete follow-up assessments at 1, 3, and 6 months after surgery.

Conditions

Pulmonary Nodule, Solitary; Peripheral Pulmonary Nodules; Pulmonary Nodules

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (7)

• Perioperative Complication Rate

  From the initiation of the localization procedure through hospital discharge, up to 14 days post-surgery.

• Localization Time

  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

  From the completion of surgery to chest drainage tube removal, assessed up to 14 days post-surgery.

• Oxygenation Index

  Postoperative day 1 and day 2.

• Postoperative Length of Hospital Stay

  From the completion of surgery to hospital discharge, assessed up to 30 days.

Study Arms (2)

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.

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.

Procedure: CT-Guided Percutaneous Lung Puncture Localization

Interventions

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.

Longitude-Latitude-Depth Localization Group

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.

CT-Guided Percutaneous Lung Puncture Localization Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (4)

Xingyi People's Hospital

Xingyi, Guizhou, 562400, China

Location

Ningxia Hui Autonomous Region People's Hospital

Yinchuan, Ningxia, 750021, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Linqing People's Hospital

Linqing, Shandong, 252600, China

Location

Related Publications (7)

• 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 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.

  PMID: 10027460 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.

  PMID: 35116651 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.

  PMID: 33717587 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.

  PMID: 32953501 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.

  PMID: 27717643 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.

  PMID: 33687468 BACKGROUND

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Zhenguo Sun, Doctor of Medicine (MD)

CONTACT

+86-185-6008-9136; sunzg@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)