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The goal of this prospective, multi-centre, randomised controlled clinical study is to evaluate the diagnostic efficacy and safety of nCLE guided lung biopsy in patients with for peripheral lung nodules under the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS), and assess whether the biopsy techniques, namely transbronchial crybiopsy (TBCB) and transbronchial forceps biopsy (TBFB), would influence the diagnostic efficacy and safety of nCLE guided biopsy.
Participants will divided into nCLE-NB-rEBUS-forcep biopsy group, nCLE-NB-rEBUS-TBCB group, NB-rEBUS-forcep biopsy group, and NB-rEBUS-TBCB group at a 1:1:1:1 ratio by using central, computerized random sequence, and then undertake nCLE-NB-rEBUS-forcep biopsy, nCLE-NB-rEBUS-TBCB, NB-rEBUS-forcep biopsy, and NB-rEBUS-TBCB according to the group.
Researchers will compare the diagnostic yield and incidence of adverse events of the four biopsy techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nCLE-NB-rEBUS-forcep biopsy | Experimental | The participants would undergo lung biopsy using forcep, under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) |
|
| nCLE-NB-rEBUS-TBCB | Experimental | The participants would undergo transbronchial crybiopsy (TBCB) , under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) |
|
| NB-rEBUS-forcep biopsy | Active Comparator | The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) |
|
| NB-rEBUS-TBCB | Active Comparator | The participants would undergo transbronchial crybiopsy (TBCB) , under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nCLE-NB-rEBUS-forcep biopsy | Procedure | The participants would undergo lung biopsy using forcep, under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) |
| Measure | Description | Time Frame |
|---|---|---|
| diagnostic yield of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS | The proportion of participants in whom the biopsy led to a definitive diagnosis. | 7 days after the biopsy |
| Sensitivity of lung forcep biopsy and TBCB under guidance of nCLE-NB-rEBUS | The proportion of participants of lung cancer in whom the biopsy led to a definitive diagnosis . | 7 days after the biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of adverse events | Symptoms and signs | 7 days after the biopsy |
| the adequacy of sample acquisition | Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hou Gang, MD | Contact | 010-84205729 | hougangcmu@163.com | |
| Deng Mingming, MD | Contact | 18801336854 | isdeng1017@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital, , 100029 | Beijing | Beijing Municipality | 100029 | China |
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| nCLE-NB-rEBUS-TBCB | Procedure | The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of bronchoscopic needle-based confocal laser endomicroscopy (nCLE) with the assistance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) |
|
| NB-rEBUS-forcep biopsy | Procedure | The participants would undergo lung biopsy using forcep, under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) |
|
| NB-rEBUS-TBCB | Procedure | The participants would undergo transbronchial crybiopsy (TBCB), under the guidance of navigation bronchoscopy (NB) and radial endobronchial ultrasound (rEBUS) |
|
| 7 days after the biopsy |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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