Diagnosis
Conditions
Keywords
Diagnosis, Peripheral pulmonary lesions, Cryobiopsy
Brief summary
To investigate the safety and efficacy of ultrafine cryoprobe biopsy by electromagnetic navigation bronchoscopy compared with biopsy forceps in the diagnosis of peripheral pulmonary nodules in a national multicenter randomized controlled trial
Detailed description
This project intends to carry out a national multicenter randomized controlled study, with traditional forceps biopsy as the control group and cryobiopsy as the experimental group, to verify the feasibility, effectiveness and safety of electromagnetic navigation bronchoscope-guided cryobiopsy in the diagnosis of peripheral pulmonary nodules, so as to provide an efficient and minimally invasive diagnostic method for the diagnosis of peripheral pulmonary nodules
Interventions
PROCEDURECryobiopsy
Cryobiopsy : Insert a 1.1mm cryoprobe along the electromagnetic navigation catheter, obtain samples with at least 2 pieces each.
PROCEDUREForceps biopsy
Forceps biopsy:Insert 1.8mm forceps along the electromagnetic navigation catheter, obtain at least five tissue samples through precise clamping.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The subjects were randomly (1:1) divided into groups. Cryobiopsy was assigned to the experimental group, while biopsy using a biopsy forceps was assigned to the control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. age 18 to 90 years; 2. pulmonary nodules detected by chest CT, suspected malignant nodules or unknown cause should be confirmed by biopsy; 3. chest CT showed that the nodule was located in the segmental bronchus and below, and the maximum diameter of the nodule was 8 mm to 30 mm.It was not accessible by conventional bronchoscopy; 4. if chest CT showed multiple pulmonary nodules, one of the pulmonary nodules was selected as the target lesion.
Exclusion criteria
1. contraindications to the bronchoscopy procedure; 2. high risk of bleeding, such as bronchial artery penetration or suspected lung metastasis of renal cell carcinoma; 3. electromagnetic source implanted in the body; 4. contraindications to anesthesia; 5. pregnant woman; 6. participated in other studies within three months and did not withdraw or finish, affect the observation of this study; 7. inability or unwillingness to provide informed consent or comply with the follow-up schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | follow-up for 12 months | The primary outcome was the diagnostic yield of ENB-guided cryobiopsy and forceps biopsy for diagnosing pulmonary lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | follow-up for one month | Adverse events related to the research |
Countries
China
Outcome results
None listed