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Not Yet Recruiting NCT07675889

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

Conditions: Pulmonary Nodule, Solitary, Peripheral Pulmonary Nodules, Pulmonary Nodules

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 274
Sponsor: Qilu Hospital of Shandong University

Location: Xingyi People's Hospital Xingyi Guizhou

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07675889). StuddyBuddy aggregates publicly available trial information.