| Registry | NCT07419620 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, diagnostic |
| Enrollment | 420 (Estimated) |
| Sponsor | China-Japan Friendship Hospital (Other) |
| Conditions | Pleural Effusion Disorder |
| Interventions | Ultrasoinc elastography-guided pleural biopsy followed by as-needed medical thoracoscopic pleural biopsy, Semi-rigid thoracoscopic pleural biopsy (Procedure) |
| Dates | start 2026-04-01 (estimated), primary completion 2028-04-01 (estimated), completion 2028-04-01 (estimated), first posted 2026-02-19, last updated 2026-02-19 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Pleural Effusion Disorder All trials of Ultrasoinc elastography-guided pleural biopsy followed by as-needed medical thoracoscopic pleural biopsy All trials of Semi-rigid thoracoscopic pleural biopsy
Brief Summary
The goal of this clinical trial is to determine whether an initial diagnostic approach using ultrasound elastography-guided pleural biopsy (UEPB) is non-inferior to immediate medical thoracoscopic pleural biopsy in terms of diagnostic yield for obtaining a definitive histopathological diagnosis in patients with exudative pleural effusion of unclear etiology.
The main questions it aims to answer are:
Is the step-up strategy (UEPB first, reserving thoracoscopy for non-diagnostic cases) non-inferior to immediate medical thoracoscopy in diagnostic yield?
Does the step-up strategy provide advantages in safety, patient tolerance, hospital stay, and cost-effectiveness compared to immediate thoracoscopy?
Researchers will compare a step-up strategy (initial UEPB, followed by medical thoracoscopy if UEPB is non-diagnostic) versus immediate medical thoracoscopic pleural biopsy to see if the step-up approach achieves comparable diagnostic accuracy while potentially reducing procedure-related burden and healthcare resource use.
Participants will:
Be randomly assigned in a 1:1 ratio to either the step-up strategy arm or the immediate medical thoracoscopy arm.
If assigned to the step-up arm: undergo UEPB under local anesthesia; if the biopsy is non-diagnostic, proceed to semi-rigid medical thoracoscopy.
If assigned to the immediate thoracoscopy arm: undergo semi-rigid medical thoracoscopic pleural biopsy as the initial and sole diagnostic procedure.
Provide tissue samples for histopathological, immunohistochemical, and molecular analyses as clinically indicated.
Complete short-term follow-up at 7 days post-procedure (by telephone or clinic visit) to monitor adverse events and symptom recovery.
If initially diagnosed with non-specific benign disease or remain undiagnosed, complete a long-term follow-up at 12 months to establish a final diagnosis.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Step-up strategy | Experimental | Procedure: Ultrasoinc elastography-guided pleural biopsy followed by as-needed medical thoracoscopic pleural biopsy | Participants in this arm will first undergo ultrasound elastography-guided pleural biopsy (UEPB) under local anaesthesia. If the biopsy specimen is non-diagnostic, participants will proceed to semi-rigid medical thoracoscopic pleural biopsy under local anaesthesia or moderate sedation. |
| Immidiate semi-rigid thoracoscopy | Active comparator | Procedure: Semi-rigid thoracoscopic pleural biopsy | Participants in this arm will undergo semi-rigid medical thoracoscopic pleural biopsy as the initial and sole diagnostic procedure. The procedure is performed under local anaesthesia or moderate sedation. Biopsy specimens are obtained under direct visualization from macroscopically abnormal pleural areas. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. Age ≥18 years; 2. Patients with exudative pleural effusion of unknown origin; 3. Patients with negative pleural fluid cytology results; 4. Patients who had not undergone pleural biopsy before enrolment. Exclusion Criteria: 1. Significantly bleeding risk, including uncorrectable coagulopathy (such as INR >1.5, platelet count <50×109 /L) or the need for ongoing anticoagulant/antiplatelet therapy that cannot be safely paused; 2. Hemodynamic instability; 3. Refractory hypoxemia despite supplemental oxygen; 4. Any severe concurrent illness or cardiopulmonary compromise that, in the investigator's judgment, makes either procedural sedation (for thoracoscopy) or a bedside biopsy (for UEPB) unsafe; 5. Pleural effusion conclusively identified as a transudate; 6. Pregnancy or lactation; 7. Any condition that, in the investigator's judgment, would compromise protocol compliance or follow-up.
| Facility | City | Country | Status |
|---|---|---|---|
| China-Japan Friendship Hospital | Beijing, Beijing Municipality | China |