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

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05781659
• Other study ID #: 2022-NHLHCRF-LX-01-0201-04
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Pleural Effusion
• Pleural Effusion, Malignant

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