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NCT Number: NCT06741839

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

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.

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Key information

Conditions

Pleural Diseases Pleural Effusion Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Mingming Deng

CONTACT

[email protected]

+86 18801336854

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Diagnostic yield

    Time frame: Up to 12 months after the procedure

    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).

Secondary outcomes

  1. Negative likelihood ratio

    Time frame: Up to 12 months after the procedure

    The negative likelihood ratio is defined as the probability of a negative biopsy result (i.e., no specific malignant or tuberculous diagnosis) in a patient who truly has the target disease (malignant pleural mesothelioma, metastatic cancer, or tuberculous pleurisy), divided by the probability of a negative biopsy result in a patient who does not have the disease.

    Because pleural biopsy results have no false positives in this study (specificity = 1, false-positive rate = 0), the NLR simplifies to 1 - sensitivity.

    It will be calculated using the final reference diagnosis at 12 months as the gold standard.

  2. Diagnostic sensitivity for specific diseases

    Time frame: Up to 12 months after the procedure

    Sensitivity of the procedure for diagnosing malignant pleural mesothelioma, metastatic cancer, and tuberculous pleurisy, as determined by the reference standard.

  3. Procedural time

    Time frame: Day of procedure

    Total duration of the thoracoscopic procedure from insertion to removal of the thoracoscope.

  4. Rate of adequate specimens for achieving molecular diagnosis

    Time frame: Within 2 weeks after the procedure (upon pathological reporting)

    Proportion of biopsy specimens that are sufficient for predictive molecular marker analysis according to tumor type (e.g., PD-L1, EGFR, ALK, ROS-1, HER2, ER, PR, BRCA, RAS, BRAF, etc.). Specimens are categorized as: (a) successful molecular marker analysis, (b) unsuccessful molecular marker analysis (explicit test failure), (c) not sent despite relevance.

  5. 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)

    Occurrence of any adverse events related to the procedure, including but not limited to: prolonged air leak, hemorrhage (graded as nil/slight self-limiting, mild requiring local vasoactive medication, moderate-to-severe requiring electrocautery or argon plasma coagulation), subcutaneous emphysema, postoperative fever, empyema, wound infection, cardiac arrhythmias, hypotension, and chest wall seeding from mesothelioma.

  6. Sampling quality (tissue depth and interpretability)

    Time frame: Within 2 weeks after the procedure (upon pathological assessment)

    Tissue depth: Biopsy quality determined based on tissue depth (e.g., deep biopsy including fatty tissue from the thoracic wall is considered high quality).

    Interpretability: Assessed as (a) easily interpretable (sufficient tissue with all diagnostic elements), (b) interpretable with some difficulty, (c) interpretable with great difficulty, (d) non-interpretable.

Study contacts

Contact information is provided by the study sponsor or research team.

Gang Hou

CONTACT

[email protected]

13840065481

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Collaborators

  • Anhui Chest Hospital
  • Henan Provincial People's Hospital
  • Shandong Public Health Clinical Center
  • Shanghai Rui Jin Hospital
  • The Second Affiliated Hospital of Harbin Medical University
  • The Second People's Hospital of Gansu Province
  • Wuhan Pulmonary Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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