An interventional study of mixed reality guided localization in Lung Cancer, sponsored by Shanghai Chest Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Diagnostic
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.
Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Application of mixed reality technique for percutaneous lung nodule localization.
Device: mixed reality guided localization
Computerized tomography (CT) guided percutaneous lung nodule localization.
In this study, MR was utilized to assist in the localization of pulmonary nodule during sublobectomy lung resection in patient to assess the accuracy of the technique.
Accuracy of nodule localization
The deviation between the local quantizer and the target nodule center was evaluated. The deviation is expressed as vertical deviation, anteroposterior deviation and horizontal deviation in three dimensions. The total deviation of nodule localization is calculated as the square root of the sum of squares of each dimension.
Time frame: 30 minutes
Operation duration
Since the start/end point of CT-guided pulmonary nodule localization may be arbitrary and there may be differences between different researchers, the program duration is derived from the CT scanning parameters and calculated as the length of time between the initial scan and the final scan. The hybrid reality guided positioning time is automatically recorded by the system from the beginning of registration to the completion of positioning
Time frame: 30 minutes
Incidence of complications
Including pneumothorax, hemoptysis, circulation changes caused by bleeding, pleural reaction, etc
Time frame: 7 days
Radiation exposure dose
The dose length product (DLP) was used to quantify the total radiation received by patients during the localization of pulmonary nodules. In addition, after the scanning process, the DLP value is directly displayed on the screen of the CT scanner. In order to estimate the relative amount of radiation dose, the effective dose (ED) is also calculated according to the DLP value
Time frame: 30 minutes
Postoperative puncture pain assessment
On the first day after the operation, when the patient was fully awake, the pain degree of the patient during the positioning process was evaluated by using the NRS (digital scoring method) and the Digital Assessment Scale of Pain Degree. The degree of pain is expressed in 0-10 numbers, 0 means no pain, and 10 means the most severe pain. It is left to the patient to choose a number that best represents the degree of pain, and the medical staff will select the corresponding number according to the patient's description of pain. According to the corresponding number of pain, the pain degree is divided into mild pain (1-3), moderate pain (4-6), and severe pain (7-10)
Time frame: 7 days
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Shanghai Chest Hospital