N/A
N=134
SharkCore Versus Acquire FNB
EUS Guided Biopsy
Bottom Line
View on ClinicalTrials.gov: NCT03672032 ↗Enrolled (actual)
134
Serious AEs
0.8%
Results posted
Jul 2021
Primary outcome: Primary: Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Histologic Yield of the Sample Obtained? — 3; 4; 10; 14 Lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fork-tip Needle (Device); Franseen Needle (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Henning Gerke
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Histologic Yield of the Sample Obtained? |
3; 4; 10; 14; 62; 57 | — |
| SECONDARY Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Diagnostic Accuracy? |
69; 65 | — |
| SECONDARY Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Number of Needle Passes Required to Obtain the Tissue Sample? |
3; 3 | — |
Summary
Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) has been established as an effective technique for sampling tissue inside and around the gastrointestinal tract, including the pancreas, liver, lymph nodes, and adrenal glands. EUS-FNA is convenient, minimally invasive, and safe procedure with an estimated sensitivity of 75%-92% and a specificity of 82%-100%.
Diagnosis of various pathologies in the GI tract including solid pancreatic masses, mediastinal or gastric lymph nodes, gastrointestinal submucosal lesions, and peri-rectal lesions require adequate tissue architecture and immunohistochemical analysis. This is difficult to obtain and is frequently insufficient with EUS-FNA cytology alone. The core tissue is required to improve the diagnostic yield and obtain histologic diagnosis along with immunostaining to establish specimen adequacy. In past 1 year two new needle EUS needle (Shark Core)and Acquire EUS needles has been introduced to improve diagnostic accuracy, tissue yield, and potentially obtain a core tissue sample. So far, no prospective studies have compared these two needles to see which one is better for overall diagnostic accuracy. Our goal is to perform a prospective analysis to compare the diagnostic yield and safety profile of these 2 new EUS needle.
Eligibility Criteria
Inclusion Criteria
- Patients schedule for EUS guided biopsy
Exclusion Criteria
- Patients who had EUS-FNA for cystic fluid aspiration
- Pregnant females
- International normalized ratio >1.5 and platelet count < 50,000
- Medically unstable
Data sourced from ClinicalTrials.gov (NCT03672032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.