Ultrathin Bronchoscopy With Virtual Bronchoscopic Navigation and Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions Without Fluoroscopy: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- The difference of diagnostic value of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jiayuan Sun
Director, Department of Endoscopy, Shanghai Chest Hospital
Shanghai Chest Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with peripheral pulmonary lesions suspected to be cancer that need pathologically confirmed;
- •Presence of bronchus leading to or adjacent to the lesion from CT scan.
Exclusion Criteria
- •Pure ground glass opacity (GGO) lesions;
- •Refusal of participation;
- •Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy;
- •Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
Outcomes
Primary Outcomes
The difference of diagnostic value of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone
Time Frame: Up to half year
The diagnostic value means diagnostic yields in two groups for benign and malignant lesions
Secondary Outcomes
- The difference of the operation time of UTB-VBN-EBUS with fluoroscopy as compared to UTB-VBN-EBUS alone(Up to half year)