Endoscopic ultrasound adequacy rates using novel needle biopsy system with and without rapid onsite evaluation of various gastrointestinal and intra-abdominal solid lesions

Background and Aims: The Shark Core Fine Needle Biopsy (FNB) System is a tissue sampling device that can provide cytology and possibly higher yield histology samples. This needle system is being evaluated for adequacy in sampling of liver, pancreatic or gastric masses, and intra-abdominal lymphadenopathy visualized on prior imaging in addition to use of rapid onsite evaluation (ROSE) for adequacy. Methods: This retrospective study evaluated FNB adequacy for diagnostic purposes in 33 adults during the first six months of use. Primary endpoint was to determine adequacy of the sample. Secondary endpoints include defining adequacy based on location of sample, the use of ROSE and number of needle passes. Results: In the six month period, of the 33 patients who met inclusion criteria, 29 (87.9%) were deemed adequate samples by final pathology report (primary end point). When ROSE was present, 25 of 26 samples (96.2%) were considered adequate with an average of 4 needle passes, when compared to 4 of 7 samples (57.1%) that were adequate in the absence of ROSE with mean of 2 needle passes. Within the liver (n=2), biliary tract (n=2), intra-abdominal lymph nodes (n=6), 100% of samples were adequate when compared with 84.2% and 75% adequacy within the pancreatic region (n= 19) and gastric region (n=4), respectively. Conclusion: Shark Core FNB revealed greater adequacy rates when ROSE was utilized initially during a familiarizing period; however without ROSE a majority of samples were still adequate with fewer needle passes. Limitations a small sample size and processing of histological samples.