Lung Ground-Glass Opacity
Conditions
Keywords
Lung Ground-Glass Opacity, Transbronchial Cryobiopsy, Forceps Biopsy, Diagnosis
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 opacity.
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 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 trial, 184 patients will be expected to enroll in the study and receive EBUS examination before biopsy to check whether the GGO lesions exist or not. This is a parallel-control study that patients with GGO lesions will be randomized to either TBCB group or TBFB group for biopsy. The primary aim is to compare the diagnostic yields of the two biopsy techniques. The secondary endpoint is to assess the tissue size, sampling time, number of sampling and the quality of specimen.
Interventions
PROCEDURETransbronchial Cryobiopsy
The eligible patient will be randomized to TBCB group to receive transbronchial cryobiopsy.
PROCEDURETransbronchial Forceps Biopsy
The eligible patient will be randomized to TBFB group to receive transbronchial forceps biopsy.
Sponsors
First Affiliated Hospital of Chongqing Medical University
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | Up to 6 Months | Diagnostic yield of transbronchial cryobiopsy (TBCB) or transbronchial forceps biopsy (TBFB) for lung ground-glass opacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tissue size | Up to 1 months | The maximum diameter measured by the biopsy tissue. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sampling time | Up to 1 months | The time spent in sampling the lesions begins with the insertion of biopsy tools into the bronchoscope work channel, and ends with the insertion of all biopsy specimens for the target lesion into the specimen bottle. |
| Number of sampling and effective sampling | Up to 1 months | The operation for biopsy purposes is taken as one sampling, whether the sample is obtained or not, and if the sample is obtained, record as effective sampling. |
| Quality of specimens | Up to 6 months | On the premise that other sample processing processes are fixed, different sampling methods will have different effects on the samples. To obtain abnormal lung tissues as eligible samples, the integrity of tissue morphology and structure preservation is an important factor in evaluating the quality of tissue samples. |
| Adverse events | Up to 1 months | To evaluate the bleeding in the biopsy site mainly, which is one of the main complications of bronchoscopy biopsy. Adverse events shall be judged in accordance with relevant regulations, and serious adverse events shall be recorded and reported in accordance with regulations. |
Countries
China
Contacts
Primary ContactJiayuan Sun, MD, PhD
Outcome results
None listed