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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound elastography guided pleural biopsy group | Experimental |
| |
| Traditional ultrasound-guided pleural biopsy group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound elastography guided pleural biopsy | Procedure | The patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of adverse events | Symptoms and signs | 7 days after the biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingming Deng, MD | Contact | 86 18801336854 | isdeng1017@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Chest Hospital | Recruiting | Hefei | Anhui | 230000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40935584 | Derived | 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. |
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| Traditional ultrasound guided pleural biopsy | Procedure | The patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy. |
|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
|
| Gui Zhou Provincial People's Hospital | Recruiting | Guiyang | Guizhou | 550000 | China |
|
| the Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410000 | China |
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| the First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330000 | China |
|
| the First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110000 | China |
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| The Tenth People's Hospital of Shenyang | Recruiting | Shenyang | Liaoning | 110000 | China |
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| the First People's Hospital of Yunnan Provience | Recruiting | Kunming | Yunnan | 650000 | China |
|
| the Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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