Ultrasounic Elastography-guided Pleural Biopsy Followed by As-needed Medical Thoracoscopic Pleural Biopsy Versus Immediate Medical Thoracoscopic Pleural Biopsy for the Diagnosis of Pleural Effusion

NCT07419620 · tracked via the Priya Life Science China tracker

Sponsor

China-Japan Friendship Hospital

Phase

Not applicable

Started

2026-04

Last updated

2026-02-19

Condition(s) studied

Pleural Effusion Disorder

Investigational drug(s) / intervention(s)

Ultrasoinc elastography-guided pleural biopsy followed by as-needed medical thoracoscopic pleural biopsySemi-rigid thoracoscopic pleural biopsy

Ultrasoinc 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.

Semi-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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
China-Japan Friendship Hospital	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07419620 on ClinicalTrials.gov ↗ ← All trials in China