The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
NCT ID: NCT05781659
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
592 participants
INTERVENTIONAL
2023-04-07
2024-12-31
Brief Summary
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Participants will undergo ultrasound elastography guided pleural biopsy or traditional ultrasound-guided pleural biopsy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Ultrasound elastography guided pleural biopsy group
Ultrasound elastography guided pleural biopsy
The patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
Traditional ultrasound-guided pleural biopsy group
Traditional ultrasound guided pleural biopsy
The patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
Interventions
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Ultrasound elastography guided pleural biopsy
The patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
Traditional ultrasound guided pleural biopsy
The patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
Eligibility Criteria
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Inclusion Criteria
2. Sign the informed consent form
3. The patient must have chest CT, biochemical examination of pleural fluid, cytological examination of pleural fluid and other data before operation
Exclusion Criteria
2. The pleural fluid cytology proved to be malignant.
3. 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.
4. Those who cannot tolerate closed pleural biopsy due to severe cardiopulmonary dysfunction and poor general condition
5. Coagulation dysfunction.
6. transudate
7. The age is less than 18 years old.
18 Years
90 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Gang Hou
Principal Investigator
Locations
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Anhui Chest Hospital
Hefei, Anhui, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Gui Zhou Provincial People's Hospital
Guiyang, Guizhou, China
the Second Xiangya Hospital of Central South University
Changsha, Hunan, China
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
the First Hospital of China Medical University
Shenyang, Liaoning, China
The Tenth People's Hospital of Shenyang
Shenyang, Liaoning, China
the First People's Hospital of Yunnan Provience
Kunming, Yunnan, China
the Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Tang Fei, MM
Role: primary
Tong Run, MD
Role: primary
Ye Xianwei, MD
Role: primary
Chen Yan, MD
Role: primary
Xu Fei, MD
Role: primary
Ma Jiangwei, MD
Role: primary
LI Chengjun, MM
Role: primary
Zhang Yunhui, MD
Role: primary
Xia Yang, MD
Role: primary
References
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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 FJ, Hou G. Ultrasonic Elastography-guided Pleural Biopsy versus Traditional Thoracic Ultrasound-guided Pleural Biopsy for the Diagnosis of Pleural Effusion: A Multicentre Randomized Trial. Eur Respir J. 2025 Sep 11:2501062. doi: 10.1183/13993003.01062-2025. Online ahead of print.
Other Identifiers
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2022-NHLHCRF-LX-01-0201-04
Identifier Type: -
Identifier Source: org_study_id
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