Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in the Diagnosis of Mediastinal Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Study for Diagnostic Value and Safety of Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in Mediastinal Lesions

Conditions
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Mediastinal Lymphadenopathy

Intervention / Treatment
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* Procedure: EBUS-TBMCB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=15 years; More than one mediastinal lesions with diameter >= 1cm was detected by thoracic CT; Indication of biopsy to identify the etiology, including recently discovered mediastinal lesions or combination of clinical respiratory symptoms and complicated lung lesions implicated by thoracic image ; Completion of necessary preoperative laboratory examination and other examinations such as cardiac ultrasound or CTA when necessary, in order to exclude potential contradictions; Informed consent form achievement. Exclusion Criteria: Contradictions to bronchoscopy examination such as severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation and so on; Failure to detect the mediastinal lesions in ultrasonic landscape; Cysts or abscess; Requirements for additional procedures other than EBUS examination (such as endobronchial biopsy); Psychiatric disorders or severe neurosis. Participation in other clinical experiments in recent 3 months; Any other conditions considered to be inappropriate to be involved in this study.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 90 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBUS-TBNA-TBMCB<br>endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was followed by endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) | Procedure: EBUS-TBMCB<br>* endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy was performed in experimental arm following EBUS-TBNA<br>|
| No Intervention: EBUS-TBNA<br>endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was performed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |