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

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. 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.

Conditions

• Pulmonary Nodule, Solitary
• Peripheral Pulmonary Nodules
• Pulmonary Nodules

Interventions

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.

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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-07-01

Completion

2028-07-01

Countries

• China

Study Locations