Lung Ground-Glass Opacity
Conditions
Keywords
ground-glass opacity, robotic-assisted bronchoscopy, confocal laser endomicroscopy, cryobiopsy
Brief 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.
Detailed description
This is a single-arm, single-center, and prospective study. Approximately 119 patients with GGO-dominant PPLs will be enrolled to undergo CLE and ssRAB-guided cryobiopsy for the diagnosis of lesions. During the procedure, CLE will be used to examine the lesion. The primary endpoint is the diagnostic yield of the procedure. The secondary endpoints include the diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the procedure, CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions, and the complication rate.
Interventions
DIAGNOSTIC_TESTCLE and ssRAB-guided cryobiopsy
All procedures are performed under general anesthesia with endotracheal intubation and mechanical ventilation. A conventional flexible bronchoscope is used to examine the subject's airway and clear the secretion. After the registration procedure is completed, the catheter of the ssRAB system is navigated to the target lesion. Cone beam computed tomography (CBCT) is used to confirm whether the target lesion has been reached. After that, an appropriate CLE probe is inserted. Right before CLE imaging, 2.5 ml of 10% fluorescein sodium is administered intravenously. CLE is then used to examine the target lesion. Based on real-time CLE imaging, the optimal biopsy location is identified and localized on the fluoroscopy. After CLE imaging, the CLE probe is retracted, followed by cryobiopsy at the same location under fluoroscopy guidance. Rapid on-site evaluation is available during the procedure to assess sample adequacy.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18 years; 2. Thin-slice chest CT showing GGO-dominant peripheral pulmonary lesions (diameter≥8mm, GGO component≥50%); 3. Suspected pulmonary malignant tumor which requires transbronchial lung biopsy for diagnosis; 4. Patients who have good compliance and sign informed consent.
Exclusion criteria
1. Diffuse GGO, suspected of benign or infectious lesions; 2. Preoperative imaging showing the target biopsy lesion adjacent to medium or large blood vessels; 3. Patients with contraindications of bronchoscopy; 4. Presence of concomitant endobronchial lesion during the bronchoscopy procedure; 5. Pregnant or lactating women; 6. Patients with known allergy for fluorescein; 7. The investigators believe that patient has other conditions that are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | 1 year | Diagnostic yield is defined as the number of diagnostic lesions divided by the total number of lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | 1 year | Diagnostic accuracy is calculated according to the standard definition using the classical 2\*2 table. |
| Diagnostic sensitivity | 1 year | Diagnostic sensitivity is calculated according to the standard definition using the classical 2\*2 table. Malignancy is considered as positive. |
| Diagnostic specificity | 1 year | Diagnostic specificity is calculated according to the standard definition using the classical 2\*2 table. Malignancy is considered as positive. |
| CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions. | 1 year | The CLE interpretation criteria for different kinds of GGO-dominant PPLs and the diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the proposed criteria in differentiating benign from malignant lesions. |
| Complication rate | 1 month | The complications refer to the total of device or procedure related adverse events during or within 1 month after the operation. |
Countries
China
Contacts
Primary ContactJiayuan Sun, MD, PhD
Outcome results
None listed