Outcomes of Ultrasound-guided Versus Blind Core Muscle Biopsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopathy
- Sponsor
- Duke University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Amount of Tissue Obtained
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The objective of the proposed study is to evaluate the clinical utility of muscle ultrasonography for improving the diagnostic yield and safety of core muscle biopsy. Our facility currently uses core (needle) biopsy to obtain muscle samples in patients 18 years old or older. Currently, there is no imaging tool used to guide the actual biopsy. As muscle biopsy is an invasive and potentially painful procedure, improving the diagnostic yield of this test is important.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Consecutive subjects scheduled for a biopsy at our EMG laboratory will be asked if they would like to participate until a total of 40 participants are obtained.
Exclusion Criteria
- •Age under 18 years.
- •Inability to provide consent for participation.
Outcomes
Primary Outcomes
Amount of Tissue Obtained
Time Frame: At time of biopsy
This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).
Number of Patients Receiving Diagnosis From Muscle Biopsy
Time Frame: At time of biopsy
The rate of achieving a specific final diagnosis in ultrasound guided muscle biopsies vs. unguided biopsies will be examined.
Secondary Outcomes
- Number of Participants With Adverse Events Related to Muscle Biopsy(Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy)
- Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue(At time of biopsy)
- Number of Participants With Inadequate Biopsy Samples(At time of pathology review)