Status:
UNKNOWN
The Efficacy and Safety of TBCB vs TBFB in Diagnosis of GGO
Lead Sponsor:
Shanghai Chest Hospital
Collaborating Sponsors:
First Affiliated Hospital of Chongqing Medical University
Conditions:
Lung Ground-Glass Opacity
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 op...
Detailed Description
The conventional biopsy method for lung ground-glass opacity (GGO) diagnosis is to use disposable guided sheath (including biopsy forceps and cell brushes) which have some limitations, such as big phy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04727190
Start Date
March 1 2021
End Date
December 30 2021
Last Update
February 2 2021
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China