Trial Outcomes & Findings for Comparison of 19g FNA and 19g FNB Needles for EUS-LB (NCT NCT03408171)
NCT ID: NCT03408171
Last Updated: 2020-04-14
Results Overview
Pre-processing Length of the longest piece (LLP) measured in centimeter
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
up to 5 days
Results posted on
2020-04-14
Participant Flow
Participant milestones
| Measure |
19-gauge FNA Needle
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
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|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of 19g FNA and 19g FNB Needles for EUS-LB
Baseline characteristics by cohort
| Measure |
19-gauge FNA Needle
n=20 Participants
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 Participants
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
|
Total
n=40 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
51 Years
n=5 Participants
|
49 Years
n=7 Participants
|
51 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White (Non-hispanic)
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White (Hispanic)
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Afroamerican
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 daysPre-processing Length of the longest piece (LLP) measured in centimeter
Outcome measures
| Measure |
19-gauge FNA Needle
n=20 Participants
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 Participants
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
|
|---|---|---|
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Pre-processing Length of the Longest Piece (LLP)
|
1.47 centimeter
Standard Deviation 0.46
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2.09 centimeter
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: 3-5 daysPost-processing Length of the longest piece (LLP) measured in centimeter
Outcome measures
| Measure |
19-gauge FNA Needle
n=20 Participants
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 Participants
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
|
|---|---|---|
|
Post-processing Length of the Longest Piece (LLP)
|
1.05 centimeter
Standard Deviation 0.42
|
1.78 centimeter
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 3-5 daysPre-processing Length of the longest piece (LLP) subgroups: \< 2 cm \> 2cm
Outcome measures
| Measure |
19-gauge FNA Needle
n=20 Participants
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 Participants
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
|
|---|---|---|
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Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm
> 2 cm
|
3 Participants
|
10 Participants
|
|
Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm
< 2 cm
|
17 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 3-5 daysPre-processing Aggregate specimen length (ASL) measured in centimeter
Outcome measures
| Measure |
19-gauge FNA Needle
n=20 Participants
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 Participants
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
|
|---|---|---|
|
Pre-processing Aggregate Specimen Length (ASL)
|
10.89 centimeter
Standard Deviation 4.38
|
15.78 centimeter
Standard Deviation 5.19
|
SECONDARY outcome
Timeframe: 3-5 daysPost-processing Aggregate specimen length (ASL) measured in centimeter
Outcome measures
| Measure |
19-gauge FNA Needle
n=20 Participants
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 Participants
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
|
|---|---|---|
|
Post-processing Aggregate Specimen Length (ASL)
|
11.4 centimeter
Standard Deviation 5.55
|
15.32 centimeter
Standard Deviation 5.24
|
SECONDARY outcome
Timeframe: 3-5 daysNumber of portal triads (PT) in the specimen.
Outcome measures
| Measure |
19-gauge FNA Needle
n=20 Participants
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 Participants
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
|
|---|---|---|
|
Portal Triads Number (Mean)
|
18.1 Portal Triads
Standard Deviation 9.3
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42.6 Portal Triads
Standard Deviation 25
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SECONDARY outcome
Timeframe: 3-5 daysNumber of portal triads (PT) in the specimen.
Outcome measures
| Measure |
19-gauge FNA Needle
n=20 Participants
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 Participants
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
|
|---|---|---|
|
Portal Triads Quantity (Median)
|
16.5 Complete number of portal triads
Interval 6.0 to 38.0
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38 Complete number of portal triads
Interval 0.0 to 81.0
|
SECONDARY outcome
Timeframe: 3-5 daysPortal triads groups, n (%) \< 11 Portal triads \> 11 Portal triads
Outcome measures
| Measure |
19-gauge FNA Needle
n=20 Participants
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 Participants
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
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|---|---|---|
|
Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads
< 11 Portal triads
|
6 Participants
|
2 Participants
|
|
Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads
> Portal triads
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 3-5 daysNo. of fragments \> 9 mm, mean (SD) Pre-processing Post-processing
Outcome measures
| Measure |
19-gauge FNA Needle
n=20 Participants
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 Participants
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
|
|---|---|---|
|
No. of Fragments > 9 mm, Mean (SD)
Pre-processing
|
3.5 Number of Fragments
Standard Deviation 2.4
|
7.7 Number of Fragments
Standard Deviation 3.7
|
|
No. of Fragments > 9 mm, Mean (SD)
Post-processing
|
1.1 Number of Fragments
Standard Deviation 1
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4.8 Number of Fragments
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 3-5 daysNumber of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle.
Outcome measures
| Measure |
19-gauge FNA Needle
n=20 Participants
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 Participants
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
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|---|---|---|
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Specimen Quality for Histologic Diagnosis
|
20 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Number AnalyzedOutcome measures
| Measure |
19-gauge FNA Needle
n=20 Participants
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 Participants
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
|
|---|---|---|
|
Length of Longest Piece
|
32.3 mm
Interval 21.6 to 49.5
|
30.2 mm
Interval 21.6 to 50.0
|
Adverse Events
19-gauge FNA Needle
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
19-gauge FNB Needle
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
19-gauge FNA Needle
n=20 participants at risk
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNA needle: A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
|
19-gauge FNB Needle
n=20 participants at risk
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
19-gauge FNB needle: A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
8/20 • 1 week
|
35.0%
7/20 • 1 week
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • 1 week
|
5.0%
1/20 • 1 week
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • 1 week
|
0.00%
0/20 • 1 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place