The Effectiveness and Safety of Electromagnetic Navigation Real-time Guided Percutaneous Lung Biopsy

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the diagnostic efficacy and safety of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology in peripheral lung lesions. The main question it aims to answer are: the effectiveness and safety of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology. Participants will undergo CT-guided percutaneous lung biopsy or percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology.

Official Title
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The Effectiveness and Safety of Percutaneous Lung Biopsy Guided by Electromagnetic Navigation Real-time Positioning Technology

Conditions
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Peripheral Lung Lesions

Intervention / Treatment
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* Procedure: CT-guided percutaneous lung biopsy
* Procedure: Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years old Imaging examination showed peripheral lung lesions Selected patients need to complete routine preoperative examinations such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc There is no contraindication for puncture biopsy 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: Severe cardiopulmonary insufficiency, extreme weakness and intolerance of patients 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 the 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
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional CT-guided percutaneous lung biopsy group<br> | Procedure: CT-guided percutaneous lung biopsy<br>* The participants would undergo CT-guided percutaneous lung biopsy.<br>|
| Experimental: Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology group<br> | Procedure: Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology<br>* The participants would undergo percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology for diagnosis of pleural effusion. | The diagnosis would be confirmed according to the pathological results or multidisciplinary discussion results (if interstitial lung disease is suspected, the multidisciplinary discussion results shall be recorded). The diagnostic efficacy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology will be compared with that of CT-guided percutaneous lung biopsy for diagnosis of pleural effusion. | 7 days after the lung biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Timer | during the operation of lung biopsy |