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NCT Number: NCT07419620

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

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.

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Key information

Conditions

Pleural Effusion Disorder Pleural Diseases Pleural Effusion Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Pleural effusion conclusively identified as a transudate;
  • Pregnancy or lactation;
  • Any condition that, in the investigator's judgment, would compromise protocol compliance or follow-up.

Treatment and study plan

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

Procedure

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

Procedure

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.

Primary outcomes

  1. Diagnostic yield

    Time frame: 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 outcomes

  1. diagnostic sensitivity

    Time frame: 7 days after procedure

    The proportion of participants with a final diagnosis of specific diseases who are correctly identified by the initial biopsy method.

  2. Diagnostic specificity

    Time frame: 7 days after procedure

    The proportion of participants with a final malignant diagnosis who are correctly identified by the initial biopsy method

  3. The avoidance of semi-rigid thoracoscopy

    Time frame: 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.

  4. The rate of unexpected chest tube drainage

    Time frame: 7 days after procedure

    Any chest tube placement after UEPB or prolonged chest tube drainage (>24 hours) after semi-rigid thoracoscopy.

Study contacts

Contact information is provided by the study sponsor or research team.

Mingming Deng

CONTACT

[email protected]

+86 18801336854

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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