Pleural Effusion Disorder
Conditions
Keywords
Pleural biopsy, Ultrasoinc elastography, Semi-rigid thoracoscopy
Brief summary
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.
Interventions
PROCEDUREUltrasoinc elastography-guided pleural biopsy followed by as-needed medical thoracoscopic pleural biopsy
Participants 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.
PROCEDURESemi-rigid thoracoscopic pleural biopsy
Participants 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.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | 7 days after the procedure | The proportion of cases with a specific diagnosis made based on the initial biopsy (UEPB or semi-rigid thoracoscopic pleural biopsy) specimens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of unexpected chest tube drainage | 7 days after procedure | Any chest tube placement after UEPB or prolonged chest tube drainage (\>24 hours) after semi-rigid thoracoscopy. |
| diagnostic sensitivity | 7 days after procedure | The proportion of participants with a final diagnosis of specific diseases who are correctly identified by the initial biopsy method. |
| Diagnostic specificity | 7 days after procedure | The proportion of participants with a final malignant diagnosis who are correctly identified by the initial biopsy method |
| The avoidance of semi-rigid thoracoscopy | 7 days after the procedure | The proportion of participants in the step-up arm who are diagnosed by UEPB alone and thus avoid semi-rigid thoracoscopy. |
Countries
China
Contacts
CONTACTMingming Deng
Outcome results
None listed