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Recruiting NCT06741839

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

No phase Interventional Pleural Diseases Pleural Effusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Confocal laser endomicroscopy guided pleural biopsy using medical thoracoscopy, Plerual biopsy using medical thoracoscopy.
Who it may be relevant to
Registry conditions: Pleural Diseases, Pleural Effusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Diagnostic yield [Time frame: Up to 12 months after the procedure]
Secondary outcome measures (6)
  • Negative likelihood ratio [Time frame: Up to 12 months after the procedure]
  • Diagnostic sensitivity for specific diseases [Time frame: Up to 12 months after the procedure]
  • Procedural time [Time frame: Day of procedure]
  • Rate of adequate specimens for achieving molecular diagnosis [Time frame: Within 2 weeks after the procedure (upon pathological reporting)]
  • Incidence of procedure-related complications [Time frame: From start of procedure up to 30 days post-procedure (or until chest tube removal and hospital discharge, whichever is longer)]
  • Sampling quality (tissue depth and interpretability) [Time frame: Within 2 weeks after the procedure (upon pathological assessment)]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • China-Japan Friendship Hospital — Beijing

Publications

  • Deng MM, Hu Y, Liu X, Feng Y, Zheng Z, Tong R, Porcel J, Hou G. Diagnostic yield and safety of probe-based confocal laser endomicroscopy-guided pleural biopsy via semirigid thoracoscope in diagnosing patients with unknown pleural effusion: a protocol for a multicentre, randomised controlled trial (COLLABORATION-I). BMJ Open. 2026 Jun 4;16(6):e117208. doi: 10.1136/bmjopen-2026-117208. PMID 42242740

Identifiers

NCT: NCT06741839 · 2022YFC2404404-3-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗