RecruitingNot ApplicableNCT06741839

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

Efficacy and Safety of Confocal Laser Endomicroscopy Guided Medical Thoracoscopy for the Diagnosis of Pleural Disease: a Multicenter Randomized Controlled Trial

Sponsor

China-Japan Friendship Hospital

Enrollment

158 participants

Start Date

Mar 11, 2025

Study Type

INTERVENTIONAL

Conditions

Pleural Diseases Pleural Effusion

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Age ≥ 18 years;
Evidence of exudative pleural effusion in which a specific diagnosis could not be determined using clinical, radiological, laboratory, or cytological examinations
Willingness to participate in the study and undergo an invasive procedure.;

Exclusion Criteria5

Pleural thickening or pleural-based mass without pleural effusion on radiologic examination;
Hemodynamic instability;
Presence of parapneumonic effusion;
Any contraindication to pleural biopsy or semirigid thoracoscopy;
Participation in other studies within three months without withdrawal or termination.

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Interventions

PROCEDUREConfocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy

After the completion of the routine thoracoscopic examination, the biopsy location was determined based on the results of chest CT/ ultrasound. The benign and malignant states of pleural lesions were explored by nCLE and image records were collected. Then, the biopsy tissues were collected under the guidance of nCLE.

PROCEDUREPlerual biopsy using medical thoracoscopy

After the completion of the routine thoracoscopic examination, the biopsy location was determined according to the results of chest CT/ ultrasound, and random pathological biopsy was performed, and biopsy tissues were collected by biopsy forceps.