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

Not Applicable

Not yet recruiting

• Conditions: Peripheral Lung Lesions
• Interventions: Procedure: CT-guided percutaneous lung biopsy; Procedure: Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology

• Registration Number: NCT05799014
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-22
• Last Update Submitted: 2023-03-22
• Study Start: 2023-03-30
• Study First Posted: 2023-04-05
• Last Update Posted: 2023-04-05
• Primary Completion: 2024-12-24
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional CT-guided percutaneous lung biopsy group	CT-guided percutaneous lung biopsy	-
Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology group	Percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology	-

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology for diagnosis of pleural effusion.	7 days after the lung biopsy	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.

Secondary Outcome Measures

Name	Time	Method
Operation time	during the operation of lung biopsy	Timer