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.
Age ≥18 years;
Patients with exudative pleural effusion of unknown origin;
Patients with negative pleural fluid cytology results;
Patients who had not undergone pleural biopsy before enrolment.
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;
Hemodynamic instability;
Refractory hypoxemia despite supplemental oxygen;
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;
Parallel
Ultrasoinc elastography-guided pleural biopsy followed by as-needed medical thoracoscopic pleural biopsy
Procedure/SurgeryParticipants receive ultrasound elastography-guided pleural biopsy (UEPB) as the first diagnostic procedure. If the UEPB specimen is non-diagnostic, participants proceed to semi-rigid medical thoracoscopic pleural biopsy.
Semi-rigid thoracoscopic pleural biopsy
Procedure/SurgeryParticipants receive semi-rigid medical thoracoscopic pleural biopsy as the initial and sole diagnostic procedure. The procedure is performed under local anaesthesia or moderate sedation, with biopsies obtained under direct visualization. A chest tube is inserted prophylactically following biopsy; chemical pleurodesis may be performed during the same procedure if clinically indicated.
Diagnostic yield
The proportion of cases with a specific diagnosis made based on the initial biopsy (UEPB or semi-rigid thoracoscopic pleural biopsy) specimens.
diagnostic sensitivity
The proportion of participants with a final diagnosis of specific diseases who are correctly identified by the initial biopsy method.
Diagnostic specificity
The proportion of participants with a final malignant diagnosis who are correctly identified by the initial biopsy method
The avoidance of semi-rigid thoracoscopy
The proportion of participants in the step-up arm who are diagnosed by UEPB alone and thus avoid semi-rigid thoracoscopy.
The rate of unexpected chest tube drainage
Any chest tube placement after UEPB or prolonged chest tube drainage (\>24 hours) after semi-rigid thoracoscopy.
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