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

Hyung Jin Won

Status: Unknown

Conditions: Percutaneous Pulmonary Nodule Biopsy

Treatments: Device: stereotaxic unit, navigation; Device: conventional biopsy technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03321994

AS-NPR-03

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Stereotaxic unit, navigation

Experimental group

Treatment:

Device: stereotaxic unit, navigation

Conventional biopsy technique

Active Comparator group

Treatment:

Device: conventional biopsy technique