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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital

About this trial

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 criteria

Qualifiers

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.;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy
  • Plerual biopsy using medical thoracoscopy

Treatment groups

158 Participants
are divided into 2 treatment groups

Sponsors and collaborators

China-Japan Friendship Hospital

Lead sponsor

Shanghai Rui Jin Hospital

Collaborator

Henan Provincial People's Hospital

Collaborator

The Second Affiliated Hospital of Harbin Medical University

Collaborator

Anhui Chest Hospital

Collaborator

Wuhan Pulmonary Hospital

Collaborator

Shandong Public Health Clinical Center

Collaborator

The Second People's Hospital of Gansu Province

Collaborator