Overview
This study aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules.
Description
This study is an open-label prospective single-center non-inferiority randomized controlled clinical trial. Patients in the Pulmonary Hospital Affiliated to Tongji University who are scheduled to undergo percutaneous puncture localization of small pulmonary nodules are used as the research subjects. According to the entry and exit criteria Patients were included in the clinical trial, and the enrolled patients were randomly divided into the AR glasses-assisted puncture localizing group (experimental group) and the CT-guided conventional pulmonary nodule puncture localizing group (control group), aiming to evaluate the puncture of pulmonary nodules guided by Intelligent AR glasses. Non-inferiority of localization compared with conventional CT-guided pulmonary nodule puncture localization.
Eligibility
Inclusion Criteria:
- Age 18-80, no gender limit;
- Chest CT shows that the nodule involves the outer third of the lung and can be removed by wedge resection;
- Chest CT (lung window mode), the maximum diameter of the nodule is ≤2 cm;
- Physical condition score ECOG 0-2 points;
- If you plan to undergo percutaneous puncture and localization of small pulmonary nodules, the puncture needle path will be determined by the attending physician;
- Patients voluntarily participate and sign informed consent.
Exclusion Criteria:
- The lesion is located in front of the scapula, and the needle path is blocked;
- The distance between the center of the lesion and the top of the diaphragm is < 3 cm;
- The lesion is adjacent to the hilus or large blood vessels;
- Pleural adhesions caused by a history of thoracotomy or pleural infection;
- The patient voluntarily withdraws midway.
