The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion

China-Japan Friendship Hospital9 sites in 1 country592 target enrollmentApril 7, 2023

ConditionsPleural Effusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pleural Effusion
Sponsor: China-Japan Friendship Hospital
Enrollment: 592
Locations: 9
Primary Endpoint: Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion.
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to evaluate the diagnostic effcacy and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion. The main question it aims to answer are: the effectiveness and safety of ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion.

Participants will undergo ultrasound elastography guided pleural biopsy or traditional ultrasound-guided pleural biopsy.

Registry

clinicaltrials.gov

Start Date

April 7, 2023

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

China-Japan Friendship Hospital

Responsible Party

Principal Investigator

Gang Hou

Principal Investigator

China-Japan Friendship Hospital

Eligibility Criteria

Inclusion Criteria

•Patients with unexplained pleural effusion (patients with pleural effusion with negative aspiration)
•Sign the informed consent form
•The patient must have chest CT, biochemical examination of pleural fluid, cytological examination of pleural fluid and other data before operation

Exclusion Criteria

•The cytological examination of pleural fluid indicates "highly suspicious" patients (unless the cytological examination results of patients are inconsistent with clinical manifestations and CT examination). The pleural fluid cytology proved to be malignant. Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis. Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition Coagulation dysfunction. Leakage. The age is less than 18 years old.
•The pleural fluid cytology proved to be malignant.
•Patients with severe pleural adhesion who cannot undergo medical thoracoscopic examination will not be randomly selected, and elastic ultrasound-guided biopsy can be performed after informed consent, as a subgroup of population analysis.
•Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition
•Coagulation dysfunction.
•The age is less than 18 years old.