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

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.

Study Overview

• Status: Recruiting
• Conditions: Pleural Effusion
• Intervention / Treatment: Procedure: Ultrasound elastography guided pleural biopsy; Procedure: Traditional ultrasound guided pleural biopsy

• Study Type: Interventional
• Enrollment (Estimated): 592
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingming Deng, MD; Phone Number: 86 18801336854; Email: isdeng1017@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Recruiting
      • Anhui Chest Hospital
      • Contact: Tang Fei, MM
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Tong Run, MD
  • Guizhou
    • Guiyang, Guizhou, China, 550000
      • Recruiting
      • Gui Zhou Provincial People's Hospital
      • Contact: Ye Xianwei, MD
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • The Second Xiangya Hospital Of Central South University
      • Contact: Chen Yan, MD
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Xu Fei, MD
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Recruiting
      • The First Hospital of China Medical University
      • Contact: Ma Jiangwei, MD
    • Shenyang, Liaoning, China, 110000
      • Recruiting
      • The Tenth People's Hospital of Shenyang
      • Contact: LI Chengjun, MM
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • Recruiting
      • the First People's Hospital of Yunnan Provience
      • Contact: Zhang Yunhui, MD
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Xia Yang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound elastography guided pleural biopsy group	Procedure: Ultrasound elastography guided pleural biopsy; The patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
Experimental: Traditional ultrasound-guided pleural biopsy group	Procedure: Traditional ultrasound guided pleural biopsy; The patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of adverse events	Symptoms and signs	7 days after the biopsy

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2023
• Primary Completion (Estimated): December 24, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 12, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: 2022-NHLHCRF-LX-01-0201-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No