Confocal Laser Endomicroscopy Assisted Ultrasound Guided Pleural Biopsy (Confocal laser)

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Pleural Effusion Disorder

Treatments: Procedure: Ultrasound-guided pleural biopsy; Procedure: Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT07040241

2025-COLLABERATION-Ⅱ

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

260 participants in 2 patient groups, including a placebo group

CLE-assisted ultrasound-guided pleural biopsy

Experimental group

Description:

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

Treatment:

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

Ultrasound-guided pleural biopsy

Placebo Comparator group

Description:

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

Treatment:

Procedure: Ultrasound-guided pleural biopsy