GGO-dominant PPLs Diagnosis Using CLE and ssRAB-guided Cryobiopsy

Официальное название

Ground-glass Opacity-dominant Peripheral Pulmonary Lesions Diagnosis Using Confocal Laser Endomicroscopy and Shape-sensing Robotic-assisted Bronchoscopy Guided Cryobiopsy: GLASS-CLEAR Study

Обзор

The purpose of the study is to evaluate the diagnostic performance and safety of cryobiopsy for ground-glass opacity (GGO)-dominant peripheral pulmonary lesions (PPLs) under the guidance of shape-sensing robotic-assisted bronchoscopy (ssRAB) combined with confocal laser endomicroscopy (CLE). Additionally, the study aims to establish CLE interpretation criteria for GGO-dominant PPLs based on histopathological characteristics and validate the proposed criteria.

Подробное описание

This is a single-arm, single-center, and prospective study. Approximately 119 patients with GGO-dominant PPLs will be enrolled to undergo CLE and ssRAB-guided cryobiopsy for the diagnosis of lesions. During the procedure, CLE will be used to examine the lesion. The primary endpoint is the diagnostic yield of the procedure. The secondary endpoints include the diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the procedure, CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions, and the complication rate.

Вмешательства

• Диагностический тест CLE and ssRAB-guided cryobiopsy
  All procedures are performed under general anesthesia with endotracheal intubation and mechanical ventilation. A conventional flexible bronchoscope is used to examine the subject's airway and clear the secretion. After the registration procedure is completed, the catheter of the ssRAB system is navigated to the target lesion. Cone beam computed tomography (CBCT) is used to confirm whether the target lesion has been reached. After that, an appropriate CLE probe is inserted. Right before CLE imagi

Первичные конечные точки

• Diagnostic yield [Срок оценки: 1 year]

Вторичные конечные точки (5)

• Diagnostic accuracy [Срок оценки: 1 year]
• Diagnostic sensitivity [Срок оценки: 1 year]
• Diagnostic specificity [Срок оценки: 1 year]
• CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions. [Срок оценки: 1 year]
• Complication rate [Срок оценки: 1 month]

Критерии участия

Критерии включения

• Age≥18 years;
• Thin-slice chest CT showing GGO-dominant peripheral pulmonary lesions (diameter≥8mm, GGO component≥50%);
• Suspected pulmonary malignant tumor which requires transbronchial lung biopsy for diagnosis;
• Patients who have good compliance and sign informed consent.

Критерии исключения

• Diffuse GGO, suspected of benign or infectious lesions;
• Preoperative imaging showing the target biopsy lesion adjacent to medium or large blood vessels;
• Patients with contraindications of bronchoscopy;
• Presence of concomitant endobronchial lesion during the bronchoscopy procedure;
• Pregnant or lactating women;
• Patients with known allergy for fluorescein;
• The investigators believe that patient has other conditions that are not suitable for the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT06910046 · IS25061

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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