Feasibility study of ultrathin bronchoscopic cryobiopsy

Not Applicable

• Conditions: Solitary pulmonary lesions; D003074

• Registration Number: JPRN-jRCTs042200021
• Lead Sponsor: Oki Masahide

Brief Summary

Forty-nine patients (98%) could undergo both forceps biopsy and cryobiopsy. Forceps biopsy, cryobiopsy and their combination provided specimens with specific pathological findings in 54%, 62%, and 74%, respectively. The size of cryobiopsy specimens was significantly larger. Bleeding occurred in most cases, but no serious adverse events occurred. Cryobiopsy using an ultrathin bronchoscope is feasible and acceptably safe, and plays a complementary role to forceps biopsy in terms of diagnostic yield.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-24
• Study Completion: 2021-06-17
• Results First Posted: 2022-09-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients with peripheral pulmonary lesion <= 30 mm in size reqiring biopsy for management decision
2. 20 years old <=
3. Informed consent

Exclusion Criteria

1. Serious concomitant medical illness
2. Lesion located within the inner second ellipse from the hilum on chest CT
3. Patients who need to undergo a bronchoscopic procedure for a nontarget lesion in the same setting
4. Patients who have evident disadvantages for cryobiopsy
5. Patients who were previously enrolled in this trial
6. Patients who underwent/will undergo bronchoscopy between the time of obtaining the consent and the study procedure
7. Pregnant woman
8. Bleeding tendency
9. Other clinical difficulties judged by investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified