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Clinical Trials/NCT05799014
NCT05799014
Not yet recruiting
Not Applicable

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

China-Japan Friendship Hospital0 sites200 target enrollmentMarch 30, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Lung Lesions
Sponsor
China-Japan Friendship Hospital
Enrollment
200
Primary Endpoint
Diagnostic accuracy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology for diagnosis of pleural effusion.
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 30, 2023
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
China-Japan Friendship Hospital
Responsible Party
Principal Investigator
Principal Investigator

Gang Hou

Principal Investigator

China-Japan Friendship Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diagnostic accuracy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology for diagnosis of pleural effusion.

Time Frame: 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 Outcomes

  • Operation time(during the operation of lung biopsy)

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