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| Name | Class |
|---|---|
| Erbe-med | UNKNOWN |
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This multicenter clinical trial evaluates the diagnostic yields of cryobiopsy and forceps biopsy for peripheral lung nodules. In the cryobiopsy group, cryobiopsy is the primary method, supplemented by forceps biopsy. Conversely, in the forceps biopsy group, forceps biopsy is the primary method, supplemented by cryobiopsy. The study also explores the complementary relationship between the two methods and examines differences in diagnostic rates based on the order in which the procedures are performed.
This is a multi center, clinical trial evaluating the diagnostic yields of cryobiopsy and forceps biopsy methods used for the biopsy of peripheral lung nodules. In the cryobiopsy group, cryobiopsy is the primary method, with forceps biopsy used as an auxiliary technique, while in the forceps biopsy group, forceps biopsy is the primary method, with cryobiopsy as the auxiliary technique. The study also investigates the complementary relationship between these biopsy methods and evaluates differences in diagnostic rates based on the sequence of the procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryobiopsy | Experimental | Cryobiopsy Group (Primary: Cryobiopsy, Auxiliary: Forceps Biopsy) In this group, cryobiopsy is performed as the primary biopsy method for sampling peripheral lung nodules. After the cryobiopsy is completed, forceps biopsy is conducted as an auxiliary method to obtain additional tissue samples. |
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| Forceps biopsy | Experimental | Forceps Biopsy Group (Primary: Forceps Biopsy, Auxiliary: Cryobiopsy) In this group, forceps biopsy is performed as the primary biopsy method for sampling peripheral lung nodules. Following the forceps biopsy, cryobiopsy is conducted as an auxiliary method to obtain additional tissue samples. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered) | Diagnostic Test | When the lung nodule is visualized by bronchoscope using RP-EBUS, cryobiopsy is performed, followed by forceps biopsy. |
| Measure | Description | Time Frame |
|---|---|---|
| The overall cumulative diagnostic yield | Pathologic diagnostic yield of primary method and overall procedures | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis Rate According to Lesion Size | This outcome measures the diagnostic success rate based on the size of the peripheral lung nodule. Lesions are categorized by size (e.g., <20 mm, 20 mm-30mm) to determine whether lesion size affects the accuracy and success of the biopsy method. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Busan | South Korea | ||||
| Yeungnam University Medical Center |
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Due to the nature of the procedures, blinding is not feasible.
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| Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered) | Diagnostic Test | When the lung nodule is visualized by bronchoscope using RP-EBUS, forceps biopsy is performed, followed by cryobiopsy. |
|
| Diagnosis Rate According to Malignant and Benign Disease Classification |
This measures the diagnostic yield of cryobiopsy and forceps biopsy by differentiating between malignant and benign lesions. The diagnostic rate is compared between cases of cancerous and non-cancerous nodules to assess the performance of the biopsy methods in each category. |
| through study completion, an average of 1 year |
| Diagnosis Rate According to Bronchus Sign | The bronchus sign refers to whether or not the lesion is connected to a bronchus, as seen on imaging. This outcome evaluates whether the presence or absence of a bronchus sign impacts the diagnostic success of the biopsies. | through study completion, an average of 1 year |
| Diagnosis Rate According to Image Classification Detected by Radial Bronchial Endoscopic Ultrasound (RP-EBUS) | This outcome assesses the diagnostic rate based on the characteristics of the lesion as identified by RP-EBUS imaging (e.g., solid, partially solid, or ground-glass opacities). The study evaluates whether different imaging characteristics influence the biopsy's diagnostic accuracy. | through study completion, an average of 1 year |
| Complication Rate | This outcome measures the incidence of complications (e.g., bleeding, pneumothorax) that occur during or after the biopsy procedure. The complication rates are compared between the two biopsy methods to evaluate their safety profiles. | through study completion, an average of 1 year |
| Daegu |
| South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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