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

Not Applicable

Recruiting

• Conditions: Pleural Effusion

• Registration Number: NCT05781659
• Lead Sponsor: China-Japan Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-03-12
• Study First Posted: 2023-03-23
• Study Start: 2023-04-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-12-24
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 592

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion.	7 days after the biopsy	The diagnosis would be confirmed according to the pathological results.

Secondary Outcome Measures

Name	Time	Method
Incidence rate of adverse events	7 days after the biopsy	Symptoms and signs

Trial Locations

Locations (9)

Anhui Chest Hospital; 🇨🇳 Hefei, Anhui, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, 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