CLE vs. ROSE for Ex Vivo Lung Biopsy Assessment

Официальное название

A Comparative Study on the Diagnostic Efficacy of Confocal Laser Endomicroscopy Versus Rapid On-Site Evaluation (ROSE) for Ex Vivo Lung Biopsy Specimens Obtained Via Bronchoscopy

Обзор

The goal of this observational study is to evaluate the diagnostic efficacy of Confocal Laser Endomicroscopy (CLE) compared to Rapid On-Site Evaluation (ROSE) for ex vivo lung biopsy specimens obtained via bronchoscopy. The main questions it aims to answer are: 1. Does CLE provide diagnostic accuracy comparable to ROSE for the real-time assessment of peripheral pulmonary lesions? 2. What is the level of consistency between CLE-detected malignant architectural patterns and ROSE-identified atypical cells? Participants with peripheral pulmonary lesions (5-50 mm) undergoing navigational bronchoscopy will have their first retrieved biopsy specimen sequentially analyzed. The specimen will undergo CLE scanning first, followed immediately by ROSE cytology, before being fixed for final histopathological examination (the gold standard). CLE and ROSE interpreters will be blinded to the final pathological results and to each other's findings. Diagnostic performance, inter-modality agreement (using Kappa statistics), and procedure times will be analyzed to determine if CLE can serve as a non-consumptive alternative to ROSE.

Вмешательства

• Диагностический тест Ex Vivo Confocal Laser Endomicroscopy (CLE) Imaging and Interpretation
  Following navigational bronchoscopy and target confirmation via radial endobronchial ultrasound (r-EBUS) and in vivo CLE, a lung biopsy is performed. The first retrieved specimen is immediately transferred to the CLE workstation. A CLE expert measures the specimen dimensions and then performs a comprehensive surface scan of the intacttissue using a confocal miniprobe. The operator records the time required for setup and imaging. Based exclusively on the real-time microarchitectural patterns (e.g
• Диагностический тест Rapid On-Site Evaluation (ROSE) Imaging and Interpretation
  Immediately following the completion of the ex vivo CLE imaging on the same biopsy specimen, the tissue undergoes ROSE processing. A ROSE expert (cytopathologist) performs a smear preparation using the CLE-scanned tissue. The specimen is then stained (e.g., Diff-Quik) and evaluated microscopically. The operator records the time required for smear preparation, staining, and interpretation. The blinded ROSE expert assesses the presence of atypical cells or diagnostic material to render a cytologic

Первичные конечные точки

• Diagnostic accuracy of ex vivo CLE versus ROSE for malignancy detection in peripheral pulmonary lesions [Срок оценки: Intraoperative - within 30 minutes of each biopsy specimen retrieval]

Вторичные конечные точки (6)

• Diagnostic performance of ex vivo CLE [Срок оценки: Intraoperative]
• Diagnostic performance of ROSE [Срок оценки: Intraoperative]
• Cohen's kappa (κ) for agreement between CLE diagnosis and final histopathology [Срок оценки: After final pathology available (within 7-10 working days)]
• Cohen's kappa (κ) for agreement between CLE structural findings and ROSE cytological findings on the same specimen [Срок оценки: Intraoperative interpretations, validated post-pathology]
• Procedure time: CLE imaging and interpretation time per specimen [Срок оценки: Intraoperative]
• Procedure time: ROSE preparation and interpretation time per specimen [Срок оценки: Intraoperative]

Критерии участия

Критерии включения

• （1）Imaging Findings: Presence of a peripheral pulmonary lesion (PPL) measuring 5 to 50 mm in maximum diameter on chest CT scan.

（2）Clinical Indication: Patients with a clinical indication for diagnostic flexible bronchoscopy and transbronchial biopsy.

（3）Consent: Provision of signed and dated written informed consent prior to any study-specific procedures.

Критерии исключения

• （1）Contraindications to Bronchoscopy: Patients with severe cardiopulmonary insufficiency or any absolute contraindication to flexible bronchoscopy (e.g., severe hypoxemia, unstable angina, or uncontrolled asthma).

（2）Coagulopathy: Patients with severe coagulation disorders (e.g., platelets <50,000/μL, INR >1.5) not corrected prior to the procedure.

（3）Pregnancy/Lactation: Pregnant or lactating women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163 — Гуанчжоу

Публикации

• Gompelmann D, Papaporfyriou A, Bal C, Merza Y, Mosleh B, Oberndorfer F, Tschernko E, Hoda MA, Idzko M. Transbronchial Cryobiopsy under Simultaneous Confocal Laser Endomicroscopy Guidance for Peripheral Pulmonary Lesions: A Pilot Study. Respiration. 2026;105(2):305-311. doi: 10.1159/000548658. Epub 2025 Sep 29. PMID 41021407

Идентификаторы

NCT: NCT07725510 · ES-2025-229-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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