Percutaneous Pulmonary Nodule Biopsy
Conditions
Brief summary
The purpose of this study was to compare the safety and efficacy of CT-guided needle guidance using stereotaxic unit, navigation versus conventional biopsy technique for the patients scheduled to undergo percutaneous pulmonary nodule biopsy.
Interventions
DEVICEstereotaxic unit, navigation
CT-guided needle guidance using stereotaxic unit, navigation
DEVICEconventional biopsy technique
CT-guided needle guidance using conventional biopsy technique
Sponsors
Hyung Jin Won
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient with localized lesions such as pulmonary nodules on chest x-ray, CT or PET CT * Histopathologic examination is necessary if lung lesion is unknown * Histologic findings affect the disease stage or treatment plan * If the investigator decides to perform a percutaneous lung biopsy because the biopsy or diagnosis through the bronchoscopy is not possible or has low risk-benefit * Patient who have consented to contraception during the period of clinical trial participation (one month after the procedure) * Patient who voluntarily agree to participate in this clinical trial and are willing to comply with the protocol
Exclusion criteria
* Patient with pulmonary function insufficiency * Patient who has difficulty in self-breathing (e.g, breathing through oxygen breathing apparatus) * Patient with Uncontrolled coagulation disorders (INR \> 1.3 or Blood platelet count \< 50,000/µl) * Patient with allergy to CT contrast agent * Patient under 19 years old or over 80 years old * Pregnant or lactating * Patient with uncontrollable systemic disease (e.g, uncontrolled hypertension, uncontrolled cardiovascular disease, etc.) * Patient who currently participating or has participated in other clinical trials within 30 days of the screening date * If it is judged inappropriate to participate in this clinical trial under the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Needle guide accuracy(mm) | 1 day | 3D distance between target point and actual needle tip |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Needle guide angle deviation(°) | 1 day | The angle deviation between the needle insertion path on the procedure plan and the path of the actually inserted needle |
| Number of needle readjustments | 1 day | Retract the inserted needle and adjust the direction |
| Number of needle reinsertion | 1 day | Needle is completely pulled out and then inserted again |
| Needle insertion time(min) | 1 day | Time from pre-CT scan to the last CT scan before lung biopsy |
| Procedure time(min) | 1 day | Time from pre-CT scan to dressing after lung biopsy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Radiation dose(DLP, mGy·cm) | 1 day | DLP(mGy·cm) = CTDIvol x scan length |
| Occurrence rate of adverse device effect(%) | 1 month | Adverse events that are correlated with the needle insertion procedure |
Contacts
Primary ContactHyung Jin Won, MD., PhD
Backup ContactSang Young Oh, MD., PhD
Outcome results
None listed