Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease

China-Japan Friendship Hospital

Status

Not yet enrolling

Conditions

Pleural Effusion

Pleural Diseases

Treatments

Procedure: Plerual biopsy using medical thoracoscopy

Procedure: Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT06741839

2022YFC2404404-3-1

Details and patient eligibility

About

A prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (nCLE) in the diagnosis of fibrinal pleurisy of unknown etiology. Patients with fibrinous pleurisy of unknown etiology who were to undergo thoracoscopic pleural biopsy were enrolled and informed consent was signed. Subjects were randomized to either the nCLE guided biopsy Group (Group A) or the visual biopsy group (Group B) according to the randomization table (1:1 ratio). nCLE was used to probe the benign and malignant status of pleural lesions, compare the consistency of random pathological biopsy or nCLE guided biopsy with histopathological results, compare whether nCLE guided biopsy can reduce the number of thoracoscopic biopsies, and follow up short-term postoperative complications to evaluate its safety.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with unilateral pleural effusion of unclear aetiology after less invasive means of diagnosis;
Patients who intend to undergo a thoracoscopic pleural biopsy to determine the cause of pleural effusion;
Sign informed consent.

Exclusion criteria

There is an uncorrectable coagulation disorder or anticoagulation therapy that cannot be stopped before surgery;
Hemodynamic instability;
Refractory hypoxemia;
Patients with pregnant and lactating patients
Any illness or condition that interferes with the completion of the initial or subsequent assessment.