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| Name | Class |
|---|---|
| Heidelberg University | OTHER |
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The clinical study is aimed to prospectively evaluate the diagnostic accuracy and the safety of adding transbronchial mediastinal cryobiopsy to standard sampling in mediastinal diseases.
A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was used to be compared. The patients involved were randomly divided into two groups. In the experimental group, EBUS-TBMCB was performed following EBUS-TBNA while in the other group, EBUS-TBNA was performed respectively. The samples obtained in the two groups were analyzed by the pathologists. Patients were followed up for confirming the diagnosis and complications. The diagnostic accuracy and prevalence of procedure-related adverse events were compared between the 2 groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS-TBNA-TBMCB | Experimental | endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was followed by endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) |
|
| EBUS-TBNA | No Intervention | endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was performed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBUS-TBMCB | Procedure | endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy was performed in experimental arm following EBUS-TBNA |
|
| Measure | Description | Time Frame |
|---|---|---|
| diagnostic yield | percentage of patients for whom the EBUS procedures provided a definite diagnosis in each arm | through study completion, an average of 1 year |
| prevalence of the procedure-related adverse events | the ratio of the number of patients who had adverse events caused by the procedure and the number of all the patients who have undergone this procedure in each arm | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| sample size | the area and diameter of sample obtained by each procedure | through study completion, an average of 1 year |
| consumed time | duration of each period in each procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ye Fan, PhD | Third Military Medical University | Principal Investigator |
| Felix Herth | Thoraxklinik - Heidelberg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Army Medical University | Chongqing | Chongqing Municipality | 400037 | China | ||
| Thoraxklinik - Heidelberg University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36279880 | Derived | Fan Y, Zhang AM, Wu XL, Huang ZS, Kontogianni K, Sun K, Fu WL, Wu N, Kuebler WM, Herth FJF. Transbronchial needle aspiration combined with cryobiopsy in the diagnosis of mediastinal diseases: a multicentre, open-label, randomised trial. Lancet Respir Med. 2023 Mar;11(3):256-264. doi: 10.1016/S2213-2600(22)00392-7. Epub 2022 Oct 22. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2022 | Oct 8, 2022 | Prot_SAP_002.pdf |
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| through study completion, an average of 1 year |
| sample adequacy | the ratio of the number of patients with adequate sample by the procedure and the number of all the patients who have undergone this procedure | through study completion, an average of 1 year |
| Heidelberg |
| Baden-Wurttemberg |
| Germany |