The Efficacy and Safety of TBCB vs TBFB in Diagnosis of GGO
Launched by SHANGHAI CHEST HOSPITAL · Jan 24, 2021
Trial Information
Current as of May 08, 2025
Unknown status
Keywords
ClinConnect Summary
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 physical damage, small biopsy tissue, etc. Cryobiospy is a new technique for biopsy developed in recent years which has many advantages over conventional biopsy, such as larger tissue, higher diagnosis yield, less complication, etc. The investigators will explore the efficacy and safety of cryobiospy vs. biopsy forceps in GGO diagnosis. The study is designed as a prospective, randomized controlled...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Male or female aged between 18 and 80.
- • 2. CT or other imaging examination suggest a tendency towards malignant GGO (size ≥ 8 mm). The ground glass composition is more than 50%.
- • 3. Thin-slice CT scan with bronchial access or adjacent lesions.
- • 4. Multidisciplinary assessment suggest that bronchopulmonary biopsy is needed to identify the pathological features of GGO.
- • 5. It is suitable for pathological biopsy by transbronchial cryobiopsy or forceps biopsy.
- • 6. Ability to read, understand and sign ICF.
- Exclusion Criteria:
- • 1. Disseminated GGO, suspected of benign or infectious lesions.
- • 2. Preoperative imaging examination showed that the biopsy lesion was adjacent to the middle or large vessels.
- • 3. There are contraindications for bronchoscopy, such as irreparable coagulation dysfunction, severe cardiopulmonary insufficiency.
- • 4. Intolerance or difficulty in cooperating with bronchoscopy, etc.
- • 5. Routine bronchoscopic abnormalities, such as endoscopic lesions, external pressure, mucosal lesions, stenosis, hemorrhage, etc.
- • 6. Vulnerable groups, such as pregnant women, etc.
- • 7. Some other special situations investigator consider subjects are not suitable to participant in this study.
About Shanghai Chest Hospital
Shanghai Chest Hospital is a leading medical institution in China, renowned for its specialized expertise in respiratory and thoracic diseases. As a prominent clinical trial sponsor, the hospital is dedicated to advancing medical research and improving patient outcomes through innovative therapies and treatments. With a strong emphasis on collaboration and scientific rigor, Shanghai Chest Hospital actively engages in a variety of clinical trials aimed at exploring novel interventions and enhancing the understanding of pulmonary health. The hospital's state-of-the-art facilities and commitment to patient-centered care position it as a key player in the global research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Trial Officials
Jiayuan Sun, MD, PhD
Study Director
Shanghai Chest Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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