Trial Title:
The Effectiveness and Safety of Ultrasound Elastography Guided Pleural Biopsy in the Differential Diagnosis of Benign and Malignant Pleural Effusion
NCT ID:
NCT05781659
Condition:
Pleural Effusion
Conditions: Official terms:
Pleural Effusion, Malignant
Pleural Effusion
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Ultrasound elastography guided pleural biopsy
Description:
The patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA)
guided pleural biopsy.
Arm group label:
Ultrasound elastography guided pleural biopsy group
Intervention type:
Procedure
Intervention name:
Traditional ultrasound guided pleural biopsy
Description:
The patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA)
guided pleural biopsy.
Arm group label:
Traditional ultrasound-guided pleural biopsy group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Chest Hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Tang Fei, MM
Facility:
Name:
China-Japan Friendship Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Tong Run, MD
Facility:
Name:
Gui Zhou Provincial People's Hospital
Address:
City:
Guiyang
Zip:
550000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ye Xianwei, MD
Facility:
Name:
the Second Xiangya Hospital of Central South University
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Chen Yan, MD
Facility:
Name:
the First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Fei, MD
Facility:
Name:
the First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ma Jiangwei, MD
Facility:
Name:
The Tenth People's Hospital of Shenyang
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Contact:
Last name:
LI Chengjun, MM
Facility:
Name:
the First People's Hospital of Yunnan Provience
Address:
City:
Kunming
Zip:
650000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhang Yunhui, MD
Facility:
Name:
the Second Affiliated Hospital Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xia Yang, MD
Start date:
April 7, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
China-Japan Friendship Hospital
Agency class:
Other
Source:
China-Japan Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05781659
