Peripheral pulmonary lesion
Conditions
Interventions
Standard device group (group A) Biopsies with standard devices (mainly forceps and aspiration needles) are performed.
Study device group (group B) Biopsies with the new 1.7-mm or 1.1-mm cryoprobe ar
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have a PPL that requires diagnosis. 2) Chest thin-section CT (TSCT) is performed within 2 months of enrollment and all the followings are true: i. The target lesion has a long diameter of 30 mm or smaller as measured by the axial image on the TSCT. ii. The target lesion is a solitary lesion in the same lobe. iii. The target lesion is more peripheral than subsegmental bronchi (third generation branches). 3) The target lesion is presumed to be reachable based on the bronchial tree on the TSCT. 4) Age at the time of informed consent is 18 years or older. 5) Participation in the study is agreed in writing by the patient.
Exclusion criteria
Exclusion criteria: 1) Patients who have a past history of any local treatment (e.g., surgery, radiation therapy) for bronchial or pulmonary lesions ipsilateral to the target lesion. 2) Patients who have poorly controlled comorbidities (i.e., severe bronchial asthma, active pulmonary infection, low pulmonary function presenting with chronic respiratory failure, unstable angina, post-acute myocardial infarction, heart failure, and severe bleeding tendency). 3) Patients who have psychosis, psychiatric symptoms, or dementia that interfere with daily life. 4) Patients who take anticoagulant and/or antiplatelet medications and cannot discontinue them for the procedure. However, as for antiplatelet agents, only acetylsalicylic acid may be continued. 5) Other patients who are judged by the attending physician to be inappropriate as the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic yield by histology | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Sensitivity, specificity, and accuracy as to malignancy diagnosis 2) Diagnostic yield by specimen type 3) Cumulative diagnostic yield by number of tissue specimens 4) Incidence of (serious) adverse events 5) Procedure time 6) Success rate of genetic testing 7) Patient reported outcomes | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactYuji Matsumoto
National Cancer Center Hospital Department of Endoscopy, Respiratory Endoscopy Division/Department of Thoracic Oncology
Outcome results
None listed