Pleural Effusion
Conditions
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.
Interventions
PROCEDUREUltrasound elastography guided pleural biopsy
The patients will undergo ultrasound elastography (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
PROCEDURETraditional ultrasound guided pleural biopsy
The patients will undergo traditional ultrasound (Aixplorer V, SuperSonic Imagine, FRA) guided pleural biopsy.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of adverse events | 7 days after the biopsy | Symptoms and signs |
Countries
China
Contacts
Primary ContactMingming Deng, MD
Outcome results
None listed