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

Primary Purpose

Pleural Effusion

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ultrasound elastography guided pleural biopsy
Traditional ultrasound guided pleural biopsy
Sponsored by
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleural Effusion

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with unexplained pleural effusion (patients with pleural effusion with negative aspiration) Sign the informed consent form The patient must have chest CT, biochemical examination of pleural fluid, cytological examination of pleural fluid and other data before operation Exclusion Criteria: 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. 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. transudate The age is less than 18 years old.

Sites / Locations

  • Anhui Chest HospitalRecruiting
  • China-Japan Friendship HospitalRecruiting
  • Gui Zhou Provincial People's HospitalRecruiting
  • the Second Xiangya Hospital of Central South UniversityRecruiting
  • the First Affiliated Hospital of Nanchang UniversityRecruiting
  • the First Hospital of China Medical UniversityRecruiting
  • The Tenth People's Hospital of ShenyangRecruiting
  • the First People's Hospital of Yunnan ProvienceRecruiting
  • the Second Affiliated Hospital Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ultrasound elastography guided pleural biopsy group

Traditional ultrasound-guided pleural biopsy group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence rate of adverse events
Symptoms and signs

Full Information

First Posted
February 24, 2023
Last Updated
March 30, 2023
Sponsor
China-Japan Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05781659
Brief Title
The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
Official Title
The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2023 (Anticipated)
Primary Completion Date
December 24, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
592 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound elastography guided pleural biopsy group
Arm Type
Experimental
Arm Title
Traditional ultrasound-guided pleural biopsy group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Ultrasound elastography guided pleural biopsy
Intervention Description
The patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
Intervention Type
Procedure
Intervention Name(s)
Traditional ultrasound guided pleural biopsy
Intervention Description
The patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
Primary Outcome Measure Information:
Title
Efficacy of ultrasound elastography guided pleural biopsy versus traditional ultrasound-guided pleural biopsy for diagnosis of pleural effusion.
Description
The diagnosis would be confirmed according to the pathological results.
Time Frame
7 days after the biopsy
Secondary Outcome Measure Information:
Title
Incidence rate of adverse events
Description
Symptoms and signs
Time Frame
7 days after the biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with unexplained pleural effusion (patients with pleural effusion with negative aspiration) Sign the informed consent form The patient must have chest CT, biochemical examination of pleural fluid, cytological examination of pleural fluid and other data before operation Exclusion Criteria: 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. 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. transudate The age is less than 18 years old.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingming Deng, MD
Phone
86 18801336854
Email
isdeng1017@163.com
Facility Information:
Facility Name
Anhui Chest Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tang Fei, MM
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tong Run, MD
Facility Name
Gui Zhou Provincial People's Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Xianwei, MD
Facility Name
the Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Yan, MD
Facility Name
the First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Fei, MD
Facility Name
the First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Jiangwei, MD
Facility Name
The Tenth People's Hospital of Shenyang
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LI Chengjun, MM
Facility Name
the First People's Hospital of Yunnan Provience
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Yunhui, MD
Facility Name
the Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Yang, MD

12. IPD Sharing Statement

Learn more about this trial

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

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