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To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in a prospective randomized study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 19Gauge Fine Needle Biopsy | Active Comparator | 19Gauge Fine Needle |
|
| 22 Gauge Fine Needle Biopsy | Active Comparator | 22Gauge Fine Needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 19G FNB | Procedure | Biopsy specimen adequacy using the 19G FNB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Longest Piece | Length of the longest piece of the liver tissue obtained | Up to 5 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Aggregate Specimen Length | Cumulative length of all the pieces of tissue obtained | 3 to 5 Days |
| Degree of Fragmentation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L Diehl, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38141686 | Derived | Diehl DL, Sangwan V, Johal AS, Khara HS, Confer B. Comparing a 19-gauge fine-needle biopsy needle with a 22-gauge fine-needle biopsy needle for EUS-guided liver biopsy sampling: a prospective randomized study. Gastrointest Endosc. 2024 Jun;99(6):931-937. doi: 10.1016/j.gie.2023.12.022. Epub 2023 Dec 21. |
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This is a prospective randomized trial comparing the biopsy specimen adequacy of 19G versus 22G core needles in subjects undergoing an EUS-LB.
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| 22G FNB | Procedure | Biopsy specimen adequacy using the 22G FNB. |
|
| 3 to 5 Days |
| Number of Portal Tracts in the Specimen | Number of portal triads will be counted in the specimens and compared for the 2 needles | 3 to 5 Days |
| Adverse Events and Serious Adverse Events | Untoward, undesired, or unplanned event | 7 to 10 Days Post Procedure |