Abnormal Liver Function
Conditions
Keywords
liver biopsy, endoscopic ultrasound guided liver biopsy, FNA, FNB
Brief summary
Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy remains an important method for helping to determine the etiology and stage of LD. Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as well as the adequacy of specimens obtained in this fashion. Most studies involve a 19-g needle, therefore in this study we hope to compare the tissue yields of a 19-g fine needle biopsy (FNB) needle, in comparison to conventional 19-g fine needle aspiration (FNA) needle. We predict that 19-g FNA and 19-g FNB needle will demonstrate similar diagnostic accuracy, with less visible blood artifact. Similarly, we predict the safety to be equal.
Interventions
DEVICE19-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.
DEVICE19-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.
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants are assigned to one of two groups for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing EUS-LB 2. Platelet count \> 50,000 3. International normalized ratio (INR) \< 1.5 4. Age \> 18 years 5. Non-pregnant patients
Exclusion criteria
1. Age \< 18 years 2. Pregnant patients 3. Inability to obtain consent 4. Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days 5. Platelet count \< 50,000 6. INR \> 1.5 7. Presence of ascites 8. Known liver cirrhosis 9. Hemophilia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-processing Length of the Longest Piece (LLP) | up to 5 days | Pre-processing Length of the longest piece (LLP) measured in centimeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm | 3-5 days | Pre-processing Length of the longest piece (LLP) subgroups: \< 2 cm \> 2cm |
| Pre-processing Aggregate Specimen Length (ASL) | 3-5 days | Pre-processing Aggregate specimen length (ASL) measured in centimeter |
| Post-processing Aggregate Specimen Length (ASL) | 3-5 days | Post-processing Aggregate specimen length (ASL) measured in centimeter |
| Portal Triads Number (Mean) | 3-5 days | Number of portal triads (PT) in the specimen. |
| Post-processing Length of the Longest Piece (LLP) | 3-5 days | Post-processing Length of the longest piece (LLP) measured in centimeter |
| Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads | 3-5 days | Portal triads groups, n (%) \< 11 Portal triads \> 11 Portal triads |
| No. of Fragments > 9 mm, Mean (SD) | 3-5 days | No. of fragments \> 9 mm, mean (SD) Pre-processing Post-processing |
| Specimen Quality for Histologic Diagnosis | 3-5 days | Number of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle. |
| Length of Longest Piece | Number Analyzed | — |
| Portal Triads Quantity (Median) | 3-5 days | Number of portal triads (PT) in the specimen. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | 19-gauge FNA Needle | 19-gauge FNB Needle | Total |
|---|---|---|---|
| Age, Continuous | 51 Years | 49 Years | 51 Years |
| Race/Ethnicity, Customized Afroamerican | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White (Hispanic) | 1 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized White (Non-hispanic) | 18 participants | 16 participants | 34 participants |
| Region of Enrollment United States | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 8 / 20 | 7 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Pre-processing Length of the Longest Piece (LLP)
Pre-processing Length of the longest piece (LLP) measured in centimeter
Time frame: up to 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 19-gauge FNA Needle | Pre-processing Length of the Longest Piece (LLP) | 1.47 centimeter | Standard Deviation 0.46 |
| 19-gauge FNB Needle | Pre-processing Length of the Longest Piece (LLP) | 2.09 centimeter | Standard Deviation 0.41 |
Secondary
Length of Longest Piece
Time frame: Number Analyzed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 19-gauge FNA Needle | Length of Longest Piece | 32.3 mm |
| 19-gauge FNB Needle | Length of Longest Piece | 30.2 mm |
Secondary
No. of Fragments > 9 mm, Mean (SD)
No. of fragments \> 9 mm, mean (SD) Pre-processing Post-processing
Time frame: 3-5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 19-gauge FNA Needle | No. of Fragments > 9 mm, Mean (SD) | Pre-processing | 3.5 Number of Fragments | Standard Deviation 2.4 |
| 19-gauge FNA Needle | No. of Fragments > 9 mm, Mean (SD) | Post-processing | 1.1 Number of Fragments | Standard Deviation 1 |
| 19-gauge FNB Needle | No. of Fragments > 9 mm, Mean (SD) | Pre-processing | 7.7 Number of Fragments | Standard Deviation 3.7 |
| 19-gauge FNB Needle | No. of Fragments > 9 mm, Mean (SD) | Post-processing | 4.8 Number of Fragments | Standard Deviation 3.6 |
Secondary
Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads
Portal triads groups, n (%) \< 11 Portal triads \> 11 Portal triads
Time frame: 3-5 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 19-gauge FNA Needle | Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads | < 11 Portal triads | 6 Participants |
| 19-gauge FNA Needle | Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads | > Portal triads | 14 Participants |
| 19-gauge FNB Needle | Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads | < 11 Portal triads | 2 Participants |
| 19-gauge FNB Needle | Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads | > Portal triads | 18 Participants |
Secondary
Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm
Pre-processing Length of the longest piece (LLP) subgroups: \< 2 cm \> 2cm
Time frame: 3-5 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 19-gauge FNA Needle | Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm | < 2 cm | 17 Participants |
| 19-gauge FNA Needle | Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm | > 2 cm | 3 Participants |
| 19-gauge FNB Needle | Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm | < 2 cm | 10 Participants |
| 19-gauge FNB Needle | Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm | > 2 cm | 10 Participants |
Secondary
Portal Triads Number (Mean)
Number of portal triads (PT) in the specimen.
Time frame: 3-5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 19-gauge FNA Needle | Portal Triads Number (Mean) | 18.1 Portal Triads | Standard Deviation 9.3 |
| 19-gauge FNB Needle | Portal Triads Number (Mean) | 42.6 Portal Triads | Standard Deviation 25 |
Secondary
Portal Triads Quantity (Median)
Number of portal triads (PT) in the specimen.
Time frame: 3-5 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 19-gauge FNA Needle | Portal Triads Quantity (Median) | 16.5 Complete number of portal triads |
| 19-gauge FNB Needle | Portal Triads Quantity (Median) | 38 Complete number of portal triads |
Secondary
Post-processing Aggregate Specimen Length (ASL)
Post-processing Aggregate specimen length (ASL) measured in centimeter
Time frame: 3-5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 19-gauge FNA Needle | Post-processing Aggregate Specimen Length (ASL) | 11.4 centimeter | Standard Deviation 5.55 |
| 19-gauge FNB Needle | Post-processing Aggregate Specimen Length (ASL) | 15.32 centimeter | Standard Deviation 5.24 |
Secondary
Post-processing Length of the Longest Piece (LLP)
Post-processing Length of the longest piece (LLP) measured in centimeter
Time frame: 3-5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 19-gauge FNA Needle | Post-processing Length of the Longest Piece (LLP) | 1.05 centimeter | Standard Deviation 0.42 |
| 19-gauge FNB Needle | Post-processing Length of the Longest Piece (LLP) | 1.78 centimeter | Standard Deviation 0.66 |
Secondary
Pre-processing Aggregate Specimen Length (ASL)
Pre-processing Aggregate specimen length (ASL) measured in centimeter
Time frame: 3-5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 19-gauge FNA Needle | Pre-processing Aggregate Specimen Length (ASL) | 10.89 centimeter | Standard Deviation 4.38 |
| 19-gauge FNB Needle | Pre-processing Aggregate Specimen Length (ASL) | 15.78 centimeter | Standard Deviation 5.19 |
Secondary
Specimen Quality for Histologic Diagnosis
Number of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle.
Time frame: 3-5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 19-gauge FNA Needle | Specimen Quality for Histologic Diagnosis | 20 Participants |
| 19-gauge FNB Needle | Specimen Quality for Histologic Diagnosis | 20 Participants |