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Ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion: a multicenter randomized controlled study

Ultrasound elastography guided pleural biopsy in the differential diagnosis of benign and malignant pleural effusion: a multicenter randomized controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100044934
Enrollment
Unknown
Registered
2021-03-31
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-11-02

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

Conditions

Malignant Pleural Effusion

Interventions

Group 1:bendable thoracoscopic conventional biopsy
Group 2:traditional ultrasound guided pleural biopsy
Group 3:ultrasound elastography-guided pleural biopsy

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients with pleural effusion of unknown origin (with negative result of pleural effusion aspiration fluid); 2.Signed informed consent; 3.Patients must have preoperative chest CT, pleural fluid biochemical examination, pleural fluid cytology and other data.

Exclusion criteria

Exclusion criteria: 1.Patients with pleural effusion cytology suggesting "high suspicion" (unless the patient's cytological examination results are inconsistent with clinical manifestations and CT examination); 2.Pleural effusion cytology proves to be malignant; 3.Patients with severe pleural adhesions who cannot undergo medical thoracoscopy, and will not be randomized and if they signed informed consent, an elastic ultrasound-guided biopsy can be performed as a subgroup; 4.With severe cardiopulmonary dysfunction, poor general condition and so on, the patients cannot tolerate closed pleural biopsy; 5.With coagulation dysfunction; 6.Leakage; 7.Aged < 18 years.

Design outcomes

Primary

MeasureTime frame
Diagnostic yield;Incidence of postoperative complications;

Secondary

MeasureTime frame
Operation time;

Countries

China

Contacts

Public ContactHou Gang

China-Japan Friendship Hospital

hougangcmu@163.com+86 13840065481

Outcome results

None listed

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