CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy
Primary Purpose
Percutaneous Pulmonary Nodule Biopsy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stereotaxic unit, navigation
conventional biopsy technique
Sponsored by
About this trial
This is an interventional other trial for 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stereotaxic unit, navigation
Conventional biopsy technique
Arm Description
Outcomes
Primary Outcome Measures
Needle guide accuracy(mm)
3D distance between target point and actual needle tip
Secondary Outcome Measures
Needle guide angle deviation(°)
The angle deviation between the needle insertion path on the procedure plan and the path of the actually inserted needle
Number of needle readjustments
Retract the inserted needle and adjust the direction
Number of needle reinsertion
Needle is completely pulled out and then inserted again
Needle insertion time(min)
Time from pre-CT scan to the last CT scan before lung biopsy
Procedure time(min)
Time from pre-CT scan to dressing after lung biopsy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03321994
Brief Title
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2017 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hyung Jin Won
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Pulmonary Nodule Biopsy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stereotaxic unit, navigation
Arm Type
Experimental
Arm Title
Conventional biopsy technique
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
stereotaxic unit, navigation
Intervention Description
CT-guided needle guidance using stereotaxic unit, navigation
Intervention Type
Device
Intervention Name(s)
conventional biopsy technique
Intervention Description
CT-guided needle guidance using conventional biopsy technique
Primary Outcome Measure Information:
Title
Needle guide accuracy(mm)
Description
3D distance between target point and actual needle tip
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Needle guide angle deviation(°)
Description
The angle deviation between the needle insertion path on the procedure plan and the path of the actually inserted needle
Time Frame
1 day
Title
Number of needle readjustments
Description
Retract the inserted needle and adjust the direction
Time Frame
1 day
Title
Number of needle reinsertion
Description
Needle is completely pulled out and then inserted again
Time Frame
1 day
Title
Needle insertion time(min)
Description
Time from pre-CT scan to the last CT scan before lung biopsy
Time Frame
1 day
Title
Procedure time(min)
Description
Time from pre-CT scan to dressing after lung biopsy
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
Radiation dose(DLP, mGy·cm)
Description
DLP(mGy·cm) = CTDIvol x scan length
Time Frame
1 day
Title
Occurrence rate of adverse device effect(%)
Description
Adverse events that are correlated with the needle insertion procedure
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyung Jin Won, MD., PhD
Phone
82-2-3010-4352
Email
hyungjin.won@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Young Oh, MD., PhD
Phone
82-2-3010-4352
Email
ojangsa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyung Jin Won, MD., PhD
Organizational Affiliation
Asan Medical Center, Seoul, Korea
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy
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