GGO-dominant PPLs Diagnosis Using CLE and ssRAB-guided Cryobiopsy

Not Applicable

Not yet recruiting

• Conditions: Lung Ground-Glass Opacity

• Registration Number: NCT06910046
• Lead Sponsor: Shanghai Chest Hospital

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.

Study Timeline

• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	1 year	Diagnostic yield is defined as the number of diagnostic lesions divided by the total number of lesions.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China