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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05781659
Other study ID # 2022-NHLHCRF-LX-01-0201-04
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 7, 2023
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source China-Japan Friendship Hospital
Contact Mingming Deng, MD
Phone 86 18801336854
Email isdeng1017@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 592
Est. completion date December 31, 2024
Est. primary completion date December 24, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: 1. Patients with unexplained pleural effusion (patients with pleural effusion with negative aspiration) 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: 1. 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. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
China China-Japan Friendship Hospital Beijing Beijing
China the Second Xiangya Hospital of Central South University Changsha Hunan
China Gui Zhou Provincial People's Hospital Guiyang Guizhou
China the Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang
China Anhui Chest Hospital Hefei Anhui
China the First People's Hospital of Yunnan Provience Kunming Yunnan
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

Sponsors (1)

Lead Sponsor Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Incidence rate of adverse events Symptoms and signs 7 days after the biopsy
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