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

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.

Conditions

• Pleural Diseases
• Pleural Effusion

Interventions

PROCEDURE

Plerual 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.

PROCEDURE

Confocal 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.

Sponsors & Collaborators

• Shanghai Rui Jin Hospital

  collaborator UNKNOWN

• Henan Provincial People's Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Anhui Chest Hospital

  collaborator OTHER

• Wuhan Pulmonary Hospital

  collaborator OTHER

• Shandong Public Health Clinical Center

  collaborator OTHER_GOV

• The Second People's Hospital of Gansu Province

  collaborator UNKNOWN

• China-Japan Friendship Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-11

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• China

Study Locations