Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Lung Cancer

Treatments

Device: Augmented reality guided localization

Study type

Interventional

Funder types

Other

Identifiers

NCT06548451

ShanghaiChestAR_multicentered

Details and patient eligibility

About

With the popularization of CT screening, the detection rate of small lung nodules has greatly increased. Therefore, the clinical thoracoscopic lung nodule biopsy and sub-lobectomy for radical resection of lung cancer are greatly required. Accurate resection of lung nodule depends on precise localization of pulmonary nodules. However, preoperative CT-guided Hook- wire positioning under local anesthesia, which is the current primary localization method, requires high equipment and expense, and may cause physical and mental trauma to the patient. Augmented reality (AR) is an innovative technology that superimpose a virtual scene into the real environment by fusing images, videos, or computer-generated models with patients during surgical operations. It can visually display the anatomical structures of organs or lesions, which significantly improves surgical efficiency. This project intends to use AR technology to localize the solitary pulmonary nodule (SPN) before surgery, compared with CT-guided Hook-wire localization. Compared with the localization of SPNs under CT guidance, AR-assisted localization technology apparently is less time-consuming and can be performed immediately before surgery under general anesthesia, lessening pain, reduce costs of time and equipment, increase the success rate of sub-lobectomy, and improve the overall efficiency of surgical treatment of pulmonary nodules.

Enrollment

270 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 and 80 years inclusive;
No distant metastasis in preoperative clinical assessment;
The attending physician's assessment confirms the need for lung nodule localization in patients undergoing sublobar resection;
Target lung nodule diameter is no more than 2 cm;
The inner edge of the target nodule is at least 2 cm away from the pulmonary artery or pulmonary vein;
Non-pleural surface nodules;
Preoperative ECOG performance status score of 0/1;
Voluntarily participating in this study and signing an informed consent form.

Exclusion criteria

More than two lung nodules need to be removed at the same time.
The target node is located in the scapular region. Because percutaneous localization is obstructed by the scapula, percutaneous localization of pulmonary nodules is not suitable for such patients.
Patients with chronic pain issues or those who have been taking pain medications for an extended period.
Patients have uncontrollable mental illness and cannot make subjective assessment.