NCT03321994UnknownNot Applicable
A Single-center, Randomized, Active-controlled and Evaluator-blind Investigator-initiated Trial to Evaluate and Compare the Efficacy and Safety of CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Patients Scheduled to Undergo Percutaneous Pulmonary Nodule Biopsy
Hyung Jin Won0 sites106 target enrollmentStarted: November 1, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 106
- Primary Endpoint
- Needle guide accuracy(mm)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Conventional biopsy technique
Active Comparator
Intervention: conventional biopsy technique (Device)
Stereotaxic unit, navigation
Experimental
Intervention: stereotaxic unit, navigation (Device)
Outcomes
Primary Outcomes
Needle guide accuracy(mm)
Time Frame: 1 day
3D distance between target point and actual needle tip
Secondary Outcomes
- Needle guide angle deviation(°)(1 day)
- Number of needle readjustments(1 day)
- Number of needle reinsertion(1 day)
- Needle insertion time(min)(1 day)
- Procedure time(min)(1 day)
Investigators
Hyung Jin Won
Professor
Asan Medical Center
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