Pleural Effusion Disorder
Conditions
Keywords
Pleural effusion, Confocal laser endomicroscopy, Pleural biopsy
Brief summary
This study aimed to evaluate the diagnostic yield and safety of confocal laser endomicroscopy and ultrasound-guided pleural biopsy in diagnosing patients with unknown pleural effusion.
Interventions
PROCEDUREConfocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy
Using the probe-based confocal laser endomicroscopy to detect the pleural, and ensure the biopsy location. Then, use the pleural biopsy tool to complete the pleural biopsy. The whole procession will under the ultrasound guidance.
PROCEDUREUltrasound-guided pleural biopsy
Using ultrasound to detect the biopsy site and perform pleural biopsy.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with exudative pleural effusion of unknown origin * Patients with negative pleural fluid cytology results * Patients diagnosed with a probable malignant pleural effusion but without a definite diagnosis and requiring further pathological evaluation * Patients who are fully informed of the purpose and method of the study, agree to participate in the study, and sign an informed consent form
Exclusion criteria
* Inability or refusal to undergo UGBx * Patients with any contraindications for pleural biopsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | The day 7 after patients received CLE-assisted ultrasound-guided pleural biopsy. | The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition. |
Contacts
Primary ContactMingming Deng, Doctor
Outcome results
None listed