Confocal Laser Endomicroscopy Assisted Ultrasound Guided Pleural Biopsy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Inability or refusal to undergo UGBx

Patients with any contraindications for pleural biopsy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Confocoal laser endomicroscopy-assisted ultrasound-guided pleural biopsy

    Procedure/Surgery

    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

    Procedure/Surgery

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

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: CLE-assisted ultrasound-guided pleural biopsyExperimental treatment 1 intervention
Group B: Ultrasound-guided pleural biopsyPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: