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Forty subjects meeting the inclusion and exclusion criteria were recruited at a single center and signed informed consent forms. Among them, 20 patients in the diffuse group and 20 patients in the localized group were randomly assigned to the conventional radial endobronchial ultrasound combined with cryobiopsy group (conventional group) and the confocal laser endomicroscopy combined with cryobiopsy group (combined group). During the operation, the operator manipulated the bronchoscope to reach the lesion. After confirming the arrival at the lesion using radial endobronchial ultrasound/confocal laser endomicroscopy, cryobiopsy was performed, and the size of the sample was recorded. CBCT scanning was conducted after cryobiopsy. If there was no hole-in-lesion image, cryobiopsy was performed again under CBCT guidance. CBCT scanning was performed after biopsy to determine whether there were any adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diffuse- Conventional Group | Active Comparator | The Diffuse-Conventional Group used conventional cryobiopsy for lung lesions. |
|
| Diffuse- Combined Group | Experimental | The Diffuse-Combined Group used CLE combined with cryobiopsy for lung lesions |
|
| Localized - Convention Group | Active Comparator | The Localized-Conventional Group used conventional cryobiopsy for lung lesions. |
|
| Localized - Combined Group | Experimental | The Localized-Combined Group used CLE combined with cryobiopsy for lung lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Confocal laser endomicroscopy combined cryobiopsy | Other | Patients in the combined group will undergo CLT combined with cryobiopsy for lung lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | The Incidence of adverse events = (the number of adverse event / the number of procedures) * 100% | 7 days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield | The diagnostic yield = (the number of successful diagnoses / the number of completed biopsies) * 100% | Immediately after the procedure |
| Hole-in-lesion rate | The rate of "hole-in-lesion" = (The number of cases with "hole-in-lesion" / The total number of cases that completed biopsy) * 100% The definition of "Hole-in-lesion": After cryobiopsy, a CBCT scan is performed, and the CBCT image shows the presence of a cavity within the lesion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163 | Guangzhou | Guangdong | 510100 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34172559 | Background | Kramer T, Wijmans L, de Bruin M, van Leeuwen T, Radonic T, Bonta P, Annema JT. Bronchoscopic needle-based confocal laser endomicroscopy (nCLE) as a real-time detection tool for peripheral lung cancer. Thorax. 2022 Apr;77(4):370-377. doi: 10.1136/thoraxjnl-2021-216885. Epub 2021 Jun 25. | |
| 26094505 | Background |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Conventional cryobiopsy | Other | Patients in the conventional group will underg cryobiopsy for lung lesions. |
|
| During the procedure |
| Wellikoff AS, Holladay RC, Downie GH, Chaudoir CS, Brandi L, Turbat-Herrera EA. Comparison of in vivo probe-based confocal laser endomicroscopy with histopathology in lung cancer: A move toward optical biopsy. Respirology. 2015 Aug;20(6):967-74. doi: 10.1111/resp.12578. Epub 2015 Jun 19. |
| 24909555 | Background | Sorokina A, Danilevskaya O, Averyanov A, Zabozlaev F, Sazonov D, Yarmus L, Lee HJ. Comparative study of ex vivo probe-based confocal laser endomicroscopy and light microscopy in lung cancer diagnostics. Respirology. 2014 Aug;19(6):907-13. doi: 10.1111/resp.12326. Epub 2014 Jun 9. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |