CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy

Not Applicable

• Conditions: Percutaneous Pulmonary Nodule Biopsy
• Interventions: Device: stereotaxic unit, navigation; Device: conventional biopsy technique

• Registration Number: NCT03321994
• Lead Sponsor: Hyung Jin Won

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-24
• Last Update Submitted: 2017-10-24
• Study First Posted: 2017-10-26
• Last Update Posted: 2017-10-26
• Study Start: 2017-11
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stereotaxic unit, navigation	stereotaxic unit, navigation	-
Conventional biopsy technique	conventional biopsy technique	-

Primary Outcome Measures

Name	Time	Method
Needle guide accuracy(mm)	1 day	3D distance between target point and actual needle tip

Secondary Outcome Measures

Name	Time	Method
Number of needle readjustments	1 day	Retract the inserted needle and adjust the direction
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 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