A Real-World Study to Evaluate the Diagnostic Value of Puncture Biopsy for Peripheral Lung Nodules Under the Guidance of Augmented Reality Navigation System Combined With Radial EBUS
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Combined Diagnostic yield
Study Overview
Brief Summary
The study is designed to evaluate the safety and effectiveness of biopsy forceps combined with puncture biopsy for the diagnosis of peripheral pulmonary nodules under the guidance of Augmented Reality Navigation System combined with radial endobronchial ultrasound (r-EBUS), and to explore the factors influencing the diagnosis rate.
Detailed Description
The study will last for no longer than 12 months. Patients will be first screened, and only after meeting all the inclusion criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive forceps biopsy combined with puncture biopsy to sample the target nodules. The primary endpoint is the combined diagnostic yield of forceps biopsy and puncture biopsy. The secondary endpoints include the success rate of biopsy, the operation time of the bronchoscope and so on.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old;
- •Chest CT shows that the peripheral lung noduleswith uncertain diagnosis are adjacent or far from the airway, and/or are difficult to obtain samples by routine biopsy as assessed by investigators;
- •Understand the research and sign the informed consent form.
Exclusion Criteria
- •Contraindications for bronchoscopy;
- •Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of surgery;
- •Bronchoscopy shows visible intra-airway nodules above the 3rd bronchus;
- •The investigator believes that the patient has other conditions that are not suitable for inclusion in this study.
Outcomes
Primary Outcomes
Combined Diagnostic yield
Time Frame: Six months
Diagnostic yield is defined as the proportion of nodules diagnosed by combined technologies in all nodulesundergoing bronchoscopy biopsy.
Secondary Outcomes
- The success rate of biopsy(Immediately after bronchoscopy biopsy)
- Diagnostic yield(Six months)
- Operation time of the bronchoscopy(Immediately after bronchoscopy biopsy)
Investigators
ShiYue Li
Professor
Guangzhou Institute of Respiratory Disease