UTB-VBN-EBUS With or Without Fluoroscopy for the Diagnosis of PPLs

Ultrathin Bronchoscopy With Virtual Bronchoscopic Navigation and Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions Without Fluoroscopy: a Randomized Controlled Trial

The purpose of this study is to evaluate the feasibility,efficacy and safety of ultrathin bronchoscopy(UTB) combined with virtual bronchoscopic navigation(VBN) and endobronchial ultrasound(EBUS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.

The investigators evaluate feasibility,efficacy and safety of UTB combined with VBN and EBUS for the diagnosis of PPLs without radiographic fluoroscopy.Bronchoscopes with a 3.0-mm distal end diameter and a 1.7-mm working channel diameter are used (BF-Y0058;Olympus).The final diagnoses are established by pathological evidence from biopsy or cytology specimen including bronchoscopy or other procedures,microbiological analysis and clinical follow-up.The study is designed as a single center prospective randomized controlled trial.The participating center is Department of endoscopy, Shanghai Chest Hospital, Shanghai Jiao Tong University, China.Subjects will be randomized (1:1) to UTB-VBN-EBUS-X-ray group and UTB-VBN-EBUS group based on a randomization schedule.The study is expected to enroll 200 patients with 100 patients of each group.

Inclusion Criteria:

1. Patients with peripheral pulmonary lesions suspected to be cancer that need pathologically confirmed;
2. Presence of bronchus leading to or adjacent to the lesion from CT scan.

Exclusion Criteria:

1. Pure ground glass opacity (GGO) lesions;
2. Refusal of participation;
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy;
4. Presence of concomitant endobronchial lesion during the brochoscopy procerdure.