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Diagnostic Efficacy of Ultrasonic Elastography-Guided Pleural Biopsy for Pleural Effusion: A Nationwide, Multicenter, Randomized Controlled Trial

Diagnostic Efficacy of Ultrasonic Elastography-Guided Pleural Biopsy for Pleural Effusion: A Nationwide, Multicenter, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114701
Enrollment
Unknown
Registered
2025-12-16
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

undiagnosed pleural effusion

Interventions

Pleural Biopsy under Medical Thoracoscopy (Group B):Pleural Biopsy under Medical Thoracoscopy
Ultrasound Elastography-guided Pleural Biopsy(Group A):Ultrasound Elastography-guided Pleural Biopsy

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with unexplained exudative pleural effusion; 2.Patients scheduled to undergo pleural biopsy to determine the etiology of the pleural effusion; 3.Provision of signed informed consent;

Exclusion criteria

Exclusion criteria: 1.Presence of uncorrectable coagulation disorders or inability to discontinue anticoagulant therapy before the procedure; 2.Hemodynamic instability; 3.Refractory hypoxemia; 4.Severe cardiopulmonary dysfunction, poor general condition, or other factors that would preclude tolerance of ultrasound-guided pleural biopsy or flexible thoracoscopy; 5.Malignant pleural effusion confirmed by cytological examination of pleural fluid (except for cases requiring histopathological subtyping); 6.Confirmed transudative effusion; 7.Age <18 years; 8.Pregnancy or lactation; 9.Any disease or condition that may interfere with the completion of the initial or subsequent evaluations;

Design outcomes

Primary

MeasureTime frame
diagnostic rate;

Secondary

MeasureTime frame
Incidence of various postoperative complications;quality of biopsy samples;time of pleural biopsy procedure;

Countries

China

Contacts

Public ContactLiwei Liao

China-Japan Friendship Hospital

291633325@qq.com+86 10 84205729

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026