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

NCT06741839 | Recruiting DMC

• 1 other identifier: 2022YFC2404404-3-1
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  The proportion of participants in whom a specific diagnosis is established following pleural biopsy via semirigid thoracoscopy, based on histopathological analysis and final reference diagnosis (including 12-month follow-up for initially benign or nonspecific results).

  Up to 12 months after the procedure

Secondary Outcomes (6)

• Negative likelihood ratio

  Up to 12 months after the procedure

• Diagnostic sensitivity for specific diseases

  Up to 12 months after the procedure

• Procedural time

  Day of procedure

• Rate of adequate specimens for achieving molecular diagnosis

  Within 2 weeks after the procedure (upon pathological reporting)

• Incidence of procedure-related complications

  From start of procedure up to 30 days post-procedure (or until chest tube removal and hospital discharge, whichever is longer)

Study Arms (2)

pCLE guided pleural biopsy via semi-rigid thoracoscopy

EXPERIMENTAL

pCLE will be introduced to detect suspected areas of the parietal pleura. The pCLE inspection will follow a standardized protocol with two main steps. First, any visible abnormalities under white light, such as nodules or thickening, will be examined with pCLE to evaluate intralesional heterogeneity and determine the best biopsy site. Second, the basal pleura will be systematically swept, covering at least two intercostal spaces above the costophrenic recess, including the diaphragmatic pleura and lower posterior chest wall, which are common sites for malignant involvement. After confirming the targeted area of the parietal pleura for pleural biopsy, the pCLE probe will be withdrawn, and a flexible forceps biopsy will be performed. This process will be repeated eight times, and eight samples will be obtained. All specimens will be transported in separate formalin containers with biopsy sequences for histopathological analysis.

Procedure: Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy

Conventional Pleural biopsy via semi-rigid thoracoscopy

PLACEBO COMPARATOR

For patients assigned to receive pleural biopsy via semi-rigid thoracoscopy alone, the parietal, visceral, and diaphragmatic pleura will be inspected, and eight biopsies will be obtained under direct vision in all suspected areas of the parietal pleura.

Procedure: Plerual biopsy using medical thoracoscopy

Interventions

Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy PROCEDURE

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.

pCLE guided pleural biopsy via semi-rigid thoracoscopy

Plerual biopsy using medical thoracoscopy PROCEDURE

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.

Conventional Pleural biopsy via semi-rigid thoracoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.;

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• 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

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Pleural Diseases; Pleural Effusion

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Gang Hou

CONTACT

13840065481; hougangcmu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: March 11, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)