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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR-guided group | Experimental | Application of augmented reality technique for percutaneous lung nodule localization. |
|
| CT-guided group | No Intervention | Computerized tomography (CT) guided percutaneous lung nodule localization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented reality guided localization | Device | In this study, AR was utilized to assist in the localization of pulmonary nodule during sublobectomy lung resection in patient to assess the accuracy of the technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of sublobar resection | The surgeon assesses whether effective lung sublobar resection has been achieved intraoperatively. Effective lung sublobar resection is defined as: (1) Completing planned sublobar resection in one session without the need for supplementary segmental or lobar resections; (2) Having a margin distance from the nodule of over 2 cm or at least 1 times the diameter of the nodule. If effective resection is not achieved, the proportion of supplementary segmental or lobar resections will be recorded. | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 augmented reality (AR) guided positioning time is automatically recorded by the system from the beginning of registration to the completion of positioning. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China | ||
| Zhongshan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42418181 | Derived | Song Z, Wang Z, Yao H, Tian Q, Liu R, Chen L, Sun M, Ma W, Gong X, Sun C, Xi J, Chen Z, Yu L, Wang Y, Kan CS, Pezzella M, Gao C, Liu H, Cheng X. Single-Encounter Augmented Reality-Guided Localization for Resection of Suspected Early-Stage Lung Cancer: A Randomized Clinical Trial. JAMA Surg. 2026 Jul 8. doi: 10.1001/jamasurg.2026.2516. Online ahead of print. |
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| 30 minutes |
| Interval time from localization to surgery | The time from completion of localization to the start of skin incision for surgery is calculated as the interval time from localization to surgery for both groups. | 60 minutes |
| Complications related to nodule localization |
| 60 minutes |
| 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. | 30 minutes |
| Dislodgement rate of the hookwire | The dislodgement of the hookwire is recorded by the operating surgeon or research assistant intraoperatively. Additionally, due to the impact of nodule depth on dislodgement rate, the distance between the lung nodule and the lung puncture point is also recorded. | 120 minutes |
| Accuracy of nodule localization | The deviation between the hookwire 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. | 30 minutes |
| Post-localization pain assessment | The post-localization pain assessment is conducted by the research assistant blindedly on the first day after surgery when the patient is fully awake. The assessment includes evaluating the patient's pain level during the localization process and at the localization site on the first day after surgery using the Numerical Rating Scale (NRS) for scoring. Additionally, pain assessment is repeated on the second day after surgery and again at 30 days after discharge (±7 days). | 40 days |
| Post-localization trauma stress disorder assessment | The post-localization trauma stress disorder assessment is conducted by the research assistant in a blinded manner on the second day after surgery and at 30 days after discharge (±7 days). The Post-traumatic Stress Disorder Checklist - Civilian Version (PCL-C) is used to evaluates the psychological trauma experienced by patients due to the localization procedure. | 40 days |
| Shanghai |
| Shanghai Municipality |
| 200030 |
| China |
| the people's second hospital Hefei | Hefei | China |
| Jiangyin Hospital of Traditional Chinese Medicine | Jiangyin | China |
| Jining No. 1 People's Hospital. | Jining | China |
| Donghai County People's Hospital | Lianyungang | China |
| the First Hospital of Hebei Medical University | Shijia Zhuang | China |
| Zhangjiagang Hospital of Traditional Chinese Medicine, | Zhangjiagang | China |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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