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Peripheral pulmonary lesions (PPLs) refer to isolated or localized lesions located in the outer one-third of the lung field. Their qualitative diagnosis is a key link in the early screening and precise treatment of lung cancer. However, due to the deep location, small size (especially those with diameters < 2 cm), and unclear relationship with bronchi of peripheral pulmonary lesions, traditional bronchoscopy is difficult to directly reach the lesion, resulting in a relatively low positive rate of biopsy. Moreover, although conventional imaging examinations (such as CT) can locate the lesions, they cannot provide a histological diagnostic basis. Percutaneous puncture under CT guidance has high risks such as pneumothorax, bleeding and pleural reaction, and has low efficiency in locating multiple lesions.
At present, there are various auxiliary techniques for the diagnosis of peripheral pulmonary nodules, each with its own advantages and disadvantages:
Hand-drawn Mapping Navigation is a manual drawing technique based on preoperative CT images. By marking the directions of bronchial branches and the positions of nodules, it provides the surgeons with intuitive path planning. Studies have shown that hand-drawn navigation combined with RP-EBUS can shorten the time for bronchoscopy to reach the biopsy site from 8.89 ± 4.09 minutes to 6.32 ± 3.10 minutes (P < 0.001), and bronchial grading and hand-drawn navigation are independent influencing factors. Compared with VBN, its advantages lie in: low cost, only requiring pen and paper or electronic drawing tools, high flexibility, and the ability to adjust the path in real time in combination with the surgeon's experience; no reliance on complex software or hardware equipment, suitable for areas with limited resources. Currently, there have been many studies exploring the clinical value of hand-drawn mapping navigation maps and comparing them with VBN. However, most of the existing studies are limited to single-center retrospective analyses and lack prospective control evidence compared with VBN.
This study aims to compare the clinical application value of hand-drawn navigation and VBN in the diagnosis of peripheral pulmonary nodules through a randomized controlled trial. The main objective is to evaluate the differences in clinical application between the hand-drawn navigation group and the VBN group in terms of bronchoscopy arrival time, positive biopsy rate, and complication occurrence rate; analyze the applicability of the two techniques in different bronchial grade nodules, etc. The study results will provide evidence-based basis for optimizing the diagnosis and treatment pathway of peripheral pulmonary nodules and lay a foundation for the development of low-cost precise navigation technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand-drawn group | Experimental | Hand-drawn navigation was employed for diagnosing patients with PPN . |
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| VBN group | Active Comparator | Virtual bronchosocopy navigation was employed for diagnosing patients with PPN . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand-drawn navigation | Other | Hand-drawn navigation employed for diagnosing patients with PPN in Hand-drawn group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Intermediate Diagnosis yield | Intermediate Diagnosis yield, which is calculated based on the follow-up data of cases where NSB was detected by bronchoscopy only. Only cases where subsequent biopsy or imaging examination confirmed non-malignant diagnosis (NSBTN) will be classified as true negatives; cases without a clear diagnosis due to lack of follow-up will be regarded as non-diagnosed. Patients who fail to navigate but switch paths to continue the biopsy to achieve a diagnosis will not be counted as successful cases. The calculation formula is (TP + SPB + NSBTN) divided by the total number of procedures. The differences between the two groups will be compared | 6 monthes after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyue Li | Contact | 02081566640 | lishiyue@gird.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36104691 | Background | Zhong CH, Su ZQ, Luo WZ, Rao WY, Feng JX, Tang CL, Chen Y, Chen XB, Fan MY, Li SY. Hierarchical clock-scale hand-drawn mapping as a simple method for bronchoscopic navigation in peripheral pulmonary nodule. Respir Res. 2022 Sep 14;23(1):245. doi: 10.1186/s12931-022-02160-0. |
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| Virtual bronchoscopy navigation | Other | Virtual bronchoscopy navigation employed for diagnosing patients with PPN in VBN group. |
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