Chronic Liver Disease
Conditions
Brief summary
To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in a prospective randomized study.
Detailed description
The 19Gauge core and 22Gauge core needles have both been used for EUS-LB with good success. Previous studies have reported good safety and tissue adequacy with both the needles, but the head-on comparison between these two needles is lacking. This is a prospective randomized trial comparing the biopsy specimen adequacy of 19Gauge versus 22Gauge core needles for EUS-LB.
Interventions
PROCEDURE19G FNB
Biopsy specimen adequacy using the 19G FNB
PROCEDURE22G FNB
Biopsy specimen adequacy using the 22G FNB.
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a prospective randomized trial comparing the biopsy specimen adequacy of 19G versus 22G core needles in subjects undergoing an EUS-LB.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing EUS-LB * Platelet Count \> 50,000 * International normalized ratio (INR) \< 1.5 * Age \> 18 years of age * Non-Pregnant Patients
Exclusion criteria
* Age \< 18 Years of Age * Pregnant Patients * Inability to obtain consent * Anticoagulants or anti-platelet agents (excluding aspirin) within the last 7 -10 days * Platelet count \< 50,000 * Presence of Ascites * Known Liver Cirrhosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Longest Piece | Up to 5 Days | Length of the longest piece of the liver tissue obtained |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aggregate Specimen Length | 3 to 5 Days | Cumulative length of all the pieces of tissue obtained |
| Degree of Fragmentation | 3 to 5 Days | Size of the fragments of the samples will be measured, then classified as small (\<5 mm), medium (5-8 mm) or large (\>8 mm), then compared for the 2 needles |
| Number of Portal Tracts in the Specimen | 3 to 5 Days | Number of portal triads will be counted in the specimens and compared for the 2 needles |
| Adverse Events and Serious Adverse Events | 7 to 10 Days Post Procedure | Untoward, undesired, or unplanned event |
Countries
United States
Outcome results
None listed