Confocal Laser Endomicroscopy Assisted Ultrasound Guided Pleural Biopsy

NCT07040241 | Not Yet Recruiting DMC

• 1 other identifier: 2025-COLLABERATION-Ⅱ
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aimed to evaluate the diagnostic yield and safety of confocal laser endomicroscopy and ultrasound-guided pleural biopsy in diagnosing patients with unknown pleural effusion.

Conditions

Pleural Effusion Disorder

Keywords

Pleural effusion; Confocal laser endomicroscopy; Pleural biopsy

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition.

  The day 7 after patients received CLE-assisted ultrasound-guided pleural biopsy.

Study Arms (2)

CLE-assisted ultrasound-guided pleural biopsy

EXPERIMENTAL

The patients in this arm will receive the CLE-assisted ultrasound-guided pleural biopsy

Procedure: Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy

Ultrasound-guided pleural biopsy

PLACEBO COMPARATOR

The patients in this arm will receive the ultrasound-guided pleural biopsy

Procedure: Ultrasound-guided pleural biopsy

Interventions

Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy PROCEDURE

Using the probe-based confocal laser endomicroscopy to detect the pleural, and ensure the biopsy location. Then, use the pleural biopsy tool to complete the pleural biopsy. The whole procession will under the ultrasound guidance.

Also known as: CLE-assisted ultrasound-guided pleural biopsy

CLE-assisted ultrasound-guided pleural biopsy

Ultrasound-guided pleural biopsy PROCEDURE

Using ultrasound to detect the biopsy site and perform pleural biopsy.

Ultrasound-guided pleural biopsy

Eligibility Criteria

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

You may qualify if:

• Adult patients with exudative pleural effusion of unknown origin
• Patients with negative pleural fluid cytology results
• Patients diagnosed with a probable malignant pleural effusion but without a definite diagnosis and requiring further pathological evaluation
• Patients who are fully informed of the purpose and method of the study, agree to participate in the study, and sign an informed consent form

You may not qualify if:

• Inability or refusal to undergo UGBx
• Patients with any contraindications for pleural biopsy

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Central Study Contacts

Mingming Deng, Doctor

CONTACT

+86 18801336854; isdeng1017@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06