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N/A Completed N=134 Randomized Single-blind Diagnostic

SharkCore Versus Acquire FNB

EUS Guided Biopsy
Source: ClinicalTrials.gov NCT03672032 ↗
Enrolled (actual)
134
Serious AEs
0.8%
Results posted
Jul 2021
Primary outcomePrimary: Is the Acquire Needle Non-inferior Compared to SharkCore Needle in Histologic Yield of the Sample Obtained? — 3; 4; 10; 14 Lesions

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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