The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in The Pulmonary Periphral Nodule

Study Overview
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Brief Summary
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Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety.

Detailed Description
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Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety. This is a multi-center prospective randomized control trial.

Official Title
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The Diagnostic Yield and Safety of Transbronchial Cryobiopsy Under The Guidance of The Endobronchial Ultrasound in The Pulmonary Periphral Nodule: A Multicenter Prospective Random Control Trial

Conditions
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Diagnosis, Complication Rate

Intervention / Treatment
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* Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients are admitted as Pulmonary Periphral Nodule, while undefined after thorough history collection, laboratory examination and radiological data. The longest diameter of the Pulmonary Periphral Nodule is less than 30mm in HRCT. The Pulmonary Periphral Nodule can be detected by radial-EBUS Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed. Routine blood test, ECG examination, coagulation function, chest HRCT have been completed. Exclusion Criteria: The longest diameter of the Pulmonary Periphral Nodule is more than 30mm. The Pulmonary Periphral lesions cannot be detected by the radial endobronchial ultrasound. The clinical examinations mentioned above are not completed. The patient cannot endure or does not agree the procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a prospective multicenter random control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transbronchial cryobiopsy<br>Transbronchial cryobiopsy was performed in the patiens of pulmonary peripheral nodule | Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)<br>* Transbronchial lung biopsy by cryoprobe or by forcep<br>|
| Other: Transbronchial lung biopsy<br>Transbronchial lung biopsy was performed in the patiens of pulmonary peripheral nodule | Procedure: Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)<br>* Transbronchial lung biopsy by cryoprobe or by forcep<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnotic yield | Percentage of definitive pathological diagnosis by transbronchial cryobiopsy | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transbronchial Cryobiopsy, Diagnostic Yield, Safety, Pulmonary Periphral Nodule