Feasibility study of ultrathin bronchoscopic cryobiopsy

JRCT ID: jRCTs042200021

Registered date:24/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Solitary pulmonary lesions
• Date of first enrollment: 24/06/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Ultrathin bronchoscopic cryobiopsy using a 1.1-mm cryoprobe

Outcome(s)

• Primary Outcome: Feasibility of cryobiopsy

Secondary Outcome

Safety
Specific pathological findings
Time of procedures
Size of specimens

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude 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

Related Information

• Primary Sponsor: Oki Masahide