Confocal Laser Endomicroscopy Assisted Ultrasound Guided Pleural Biopsy

NCT ID: NCT07040241

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pleural Effusion Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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CLE-assisted ultrasound-guided pleural biopsy

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

Group Type EXPERIMENTAL

Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy

Intervention Type 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.

Ultrasound-guided pleural biopsy

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

Group Type PLACEBO_COMPARATOR

Ultrasound-guided pleural biopsy

Intervention Type PROCEDURE

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

Interventions

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Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy

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.

Intervention Type PROCEDURE

Ultrasound-guided pleural biopsy

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

Intervention Type PROCEDURE

Other Intervention Names

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CLE-assisted ultrasound-guided pleural biopsy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gang Hou

Deputy Director of the Department of Pulmonary and Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mingming Deng, Doctor

Role: CONTACT

+86 18801336854

Other Identifiers

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2025-COLLABERATION-Ⅱ

Identifier Type: -

Identifier Source: org_study_id

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