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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Site details revised at 4 of 4 sites
    • Publications: details revised at 7 of 7 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07675889
Lead Sponsor Qilu Hospital of Shandong University
Conditions
(from sponsor)		 Pulmonary Nodule, Solitary, Peripheral Pulmonary Nodules, Pulmonary Nodules
Related terms Multiple Pulmonary Nodules, Solitary Pulmonary Nodule
Enrollment 274 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov