Safety Clinical Trial
Official title:
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases: a Prospective Randomized Control Trial
| NCT number | NCT03927235 |
| Other study ID # | 2018-3-30 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 16, 2019 |
| Est. completion date | May 15, 2020 |
Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | May 15, 2020 |
| Est. primary completion date | May 15, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: 1. The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data. 2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed. 3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed. Exclusion Criteria: 1. The radiological data indicates non-DPLD 2. The clinical examinations mentioned above are not completed. 3. The patient cannot endure or does not agree the procedure. |
| Country | Name | City | State |
|---|---|---|---|
| China | the First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Guangzhou Institute of Respiratory Disease |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnotic yield | Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy | two weeks | |
| Secondary | Complication rate | Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy | one week |
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