The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
1 other identifier
interventional
592
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2023
CompletedFirst Posted
Study publicly available on registry
March 23, 2023
CompletedStudy Start
First participant enrolled
April 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 12, 2024
March 1, 2024
1.7 years
February 24, 2023
March 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion.
The diagnosis would be confirmed according to the pathological results.
7 days after the biopsy
Secondary Outcomes (1)
Incidence rate of adverse events
7 days after the biopsy
Study Arms (2)
Ultrasound elastography guided pleural biopsy group
EXPERIMENTALTraditional ultrasound-guided pleural biopsy group
EXPERIMENTALInterventions
The patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
The patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- transudate
- The age is less than 18 years old.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Anhui Chest Hospital
Hefei, Anhui, 230000, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100000, China
Gui Zhou Provincial People's Hospital
Guiyang, Guizhou, 550000, China
the Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
the First Hospital of China Medical University
Shenyang, Liaoning, 110000, China
The Tenth People's Hospital of Shenyang
Shenyang, Liaoning, 110000, China
the First People's Hospital of Yunnan Provience
Kunming, Yunnan, 650000, China
the Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Related Publications (1)
Deng M, Xia Y, Ye X, Ma J, Zhao S, Zhang Q, Li J, Lin J, Jing A, Li ZY, Jiang B, Wu J, Wen Q, Ma J, Tong R, Zheng Z, Xu W, Li X, Herth FJF, Hou G. Ultrasonic elastography-guided pleural biopsy versus traditional thoracic ultrasound-guided pleural biopsy for the diagnosis of pleural effusion: a multicentre, randomised trial. Eur Respir J. 2025 Dec 18;66(6):2501062. doi: 10.1183/13993003.01062-2025. Print 2025 Dec.
PMID: 40935584DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 24, 2023
First Posted
March 23, 2023
Study Start
April 7, 2023
Primary Completion
December 24, 2024
Study Completion
December 31, 2024
Last Updated
March 12, 2024
Record last verified: 2024-03