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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotaxic unit, navigation | Experimental |
| |
| Conventional biopsy technique | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotaxic unit, navigation | Device | CT-guided needle guidance using stereotaxic unit, navigation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Needle guide accuracy(mm) | 3D distance between target point and actual needle tip | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Needle guide angle deviation(°) | The angle deviation between the needle insertion path on the procedure plan and the path of the actually inserted needle | 1 day |
| Number of needle readjustments |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation dose(DLP, mGy·cm) | DLP(mGy·cm) = CTDIvol x scan length | 1 day |
| Occurrence rate of adverse device effect(%) | Adverse events that are correlated with the needle insertion procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyung Jin Won, MD., PhD | Contact | 82-2-3010-4352 | hyungjin.won@gmail.com | |
| Sang Young Oh, MD., PhD | Contact | 82-2-3010-4352 | ojangsa@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyung Jin Won, MD., PhD | Asan Medical Center, Seoul, Korea | Principal Investigator |
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| conventional biopsy technique | Device | CT-guided needle guidance using conventional biopsy technique |
|
Retract the inserted needle and adjust the direction
| 1 day |
| Number of needle reinsertion | Needle is completely pulled out and then inserted again | 1 day |
| Needle insertion time(min) | Time from pre-CT scan to the last CT scan before lung biopsy | 1 day |
| Procedure time(min) | Time from pre-CT scan to dressing after lung biopsy | 1 day |
| 1 month |