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The Efficacy and Safety of TBCB vs TBFB in Diagnosis of GGO

China184 participantsStarted 2021-03-01

Plain-language summary

The aim of this study is to investigate the difference of efficacy and safety between transbronchial cryobiopsy (TBCB) and transbronchial forceps biopsy (TBFB) in the diagnosis of lung ground-glass opacity.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Male or female aged between 18 and 80.
✓. CT or other imaging examination suggest a tendency towards malignant GGO (size ≥ 8 mm). The ground glass composition is more than 50%.
✓. Thin-slice CT scan with bronchial access or adjacent lesions.
✓. Multidisciplinary assessment suggest that bronchopulmonary biopsy is needed to identify the pathological features of GGO.
✓. It is suitable for pathological biopsy by transbronchial cryobiopsy or forceps biopsy.
✓. Ability to read, understand and sign ICF.

Exclusion criteria

✕. Disseminated GGO, suspected of benign or infectious lesions.
✕. Preoperative imaging examination showed that the biopsy lesion was adjacent to the middle or large vessels.
✕. There are contraindications for bronchoscopy, such as irreparable coagulation dysfunction, severe cardiopulmonary insufficiency.
✕. Intolerance or difficulty in cooperating with bronchoscopy, etc.
✕. Routine bronchoscopic abnormalities, such as endoscopic lesions, external pressure, mucosal lesions, stenosis, hemorrhage, etc.
✕. Vulnerable groups, such as pregnant women, etc.
✕. Some other special situations investigator consider subjects are not suitable to participant in this study.

What they're measuring

Diagnostic yield

Timeframe: Up to 6 Months

Trial details

NCT IDNCT04727190

SponsorShanghai Chest Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-30

Contact for this trial

Jiayuan Sun, MD, PhD

+86-021-22200000 xkyyjysun@163.com

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