Study on Transbronchial Ultrasound-guided Cryobiopsy in the Diagnosis of Mediastinal Lymphadenopathy

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to evaluate the diagnostic effcacy and safety of transbronchial ultrasound-guided cryobiopsy in the diagnosis of mediastinal lymphadenopathy. The main question it aims to answer are: the effectiveness and safety of transbronchial ultrasound-guided cryobiopsy in the diagnosis of mediastinal lymphadenopathy. Participants will undergo transbronchial ultrasound-guided cryobiopsy (EBUS-TBCB) and endobronchial ultrasound-guided trans-bronchial needle aspiration (EBUS-TBNA).

Official Title
-----------------
The Effectiveness and Safety of Transbronchial Ultrasound-guided Cryobiopsy in the Diagnosis of Mediastinal Lymphadenopathy

Conditions
-----------------
Mediastinal Lymphadenopathy

Intervention / Treatment
-----------------
* Device: EBUS-TBNA
* Device: EBUS-TBCB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients withmediastinal lymphadenopathy of unknown cause, patients with suspected sarcoidosis or lymphoma, or patients who need to undergo EBUS-TBNA for the second time The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBCB before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc There was no contraindication of puncture and cryobiopsy No age limit, no gender limit Good compliance, able to cooperate with research and observation Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form Exclusion Criteria: The patient is allergic to lidocaine and midazolam The site to be biopsied has a high risk of bleeding such as bronchial artery penetration or suspected lung metastasis of renal cancer Unstable angina pectoris, congestive heart failure, severe bronchial asthma The patient did not agree to participate in this study Participation in other studies within three months without withdrawal or termination will affect the observation of this study The researcher believes that there is any person who is not suitable for the selection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First EBUS-TBCB and then EBUS-TBNA group<br>The patients will undergo first endobronchial ultrasound-guided transbronchial ultrasound-guided cryobiopsy（EBUS-TBCB) and endobronchial ultrasound-guided transbronchial needle aspiration（EBUS-TBNA)：Routine bronchoscopy was completed, and under the guidance of EBUS, combined with CT EBUS-TBNA was used to repeatedly aspirate the tissue for 3 times (One needle is 20-50 back and forth). After the end of puncture, EBUS-TBCB was performed again, and the frozen time was about 10-15s (1.1mm cryoprobe), and the frozen time was 2-3 times to obtain at least 2 samples with a diameter of more than 5mm. | Device: EBUS-TBNA<br>* Participants would undergo EBUS-TBNA(NA-201SX-4022, OLYMPUS MEDICAL SYSTEMS CORP, JAPAN).<br>Device: EBUS-TBCB<br>* Participants would undergo EBUS-TBCB(20402-401, ERBE Elektromedizin Gmbh, Germany).<br>|
| Experimental: First EBUS-TBNA and then EBUS-TBCB group<br>The patients will undergo first endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and then endobronchial ultrasound-guided transbronchial ultrasound-guided cryobiopsy (EBUS-TBCB): Routine bronchoscopy was completed, combined with CT, EBUS-TBNA needle was used to determine the puncture site, and the sheath tube was used to slightly enlarge the local needle hole for EBUS-TBCB. The freezing time was about 10-15 seconds (1.1mm cryoprobe), and the freezing time was 2-3 times. To obtain at least two pieces of samples with a diameter of more than 5mm. After TBCB, EBUS-TBNA was performed in the same lymph node with 3 repeated tissue aspirations (20-50 back and back per needle). | Device: EBUS-TBNA<br>* Participants would undergo EBUS-TBNA(NA-201SX-4022, OLYMPUS MEDICAL SYSTEMS CORP, JAPAN).<br>Device: EBUS-TBCB<br>* Participants would undergo EBUS-TBCB(20402-401, ERBE Elektromedizin Gmbh, Germany).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological diagnosis rate | The diagnosis would be confirmed according to the pathological results | 7 days after the biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of adverse events | Symptoms and signs | 7 days after the biopsy | 
| Size of specimen | measurement | during the procedure | 
| Specimen quality | questionnaire | during the procedure |