Clinical trial NCT03321994: CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Pulmonary Nodule Biopsy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 106
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Needle guide accuracy(mm)
timeFrame: 1 day
Secondary outcomes:
measure: Needle guide angle deviation(°)
timeFrame: 1 day
measure: Number of needle readjustments
timeFrame: 1 day
measure: Number of needle reinsertion
timeFrame: 1 day
measure: Needle insertion time(min)
timeFrame: 1 day
measure: Procedure time(min)
timeFrame: 1 day
Other outcomes:
measure: Radiation dose(DLP, mGy·cm)
timeFrame: 1 day
measure: Occurrence rate of adverse device effect(%)
timeFrame: 1 month
Locations:
Study officials:
affiliation: Asan Medical Center, Seoul, Korea
name: Hyung Jin Won, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: