Not Yet RecruitingNot Applicable

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

China119 participantsStarted 2025-04

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Diagnostic yield

Timeframe: 1 year

Trial details

NCT IDNCT06910046

SponsorShanghai Chest Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04

Contact for this trial

Jiayuan Sun, MD, PhD

86-021-22200000 jysun1976@163.com

View on ClinicalTrials.gov More Lung Ground-Glass Opacity trials