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 | Not Yet Recruiting DMC

• 1 other identifier: UPDATE-3
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion Disorder

Keywords

Pleural biopsy; Ultrasoinc elastography; Semi-rigid thoracoscopy

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  The proportion of cases with a specific diagnosis made based on the initial biopsy (UEPB or semi-rigid thoracoscopic pleural biopsy) specimens.

  7 days after the procedure

Secondary Outcomes (4)

• diagnostic sensitivity

  7 days after procedure

• Diagnostic specificity

  7 days after procedure

• The avoidance of semi-rigid thoracoscopy

  7 days after the procedure

• The rate of unexpected chest tube drainage

  7 days after procedure

Study Arms (2)

Step-up strategy

EXPERIMENTAL

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.

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

Immidiate semi-rigid thoracoscopy

ACTIVE COMPARATOR

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.

Procedure: Semi-rigid thoracoscopic pleural biopsy

Interventions

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.

Step-up strategy

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.

Immidiate semi-rigid thoracoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Central Study Contacts

Mingming Deng

CONTACT

+86 18801336854; isdeng1017@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

CN (1)