SHARKCORE BIOPSY NEEDLE VERSUS STANDARD FNA NEEDLE IN THE DIAGNOSIS OF SOLID PANCREATIC MASSES: A RANDOMIZED CROSSOVER STUDY

Background & Aims: In an attempt to overcome the limitations of Endoscopic ultrasound (EUS)fine needle aspiration (FNA)a fine needle biopsy (FNB)needle (SharkCore™)with a novel fork-tip, has been introduced. This needle is designed to increase tissue yield and preserve tissue architecture with the intention of improving sample adequacy and diagnostic accuracy. The aim of this study was to determine if FNB histology samples had better diagnostic performance for solid pancreatic masses than FNA cytology samples. Methods: In this randomized crossover study consecutive patients referred to our tertiary center for EUS-guided sampling of solid pancreatic lesions were recruited. Each patient had 3 passes with a standard (Beacon™)FNA needle and 3 passes with a core (SharkCore™)FNB needle performed in a randomized order. 25g needles were used for transduodenal sampling and 22g for transgastric. A single slide was made from each pass with the FNA needle and the remaining aspirate placed in CytoRich™ fluid and sent for liquid based cytological analysis. All samples from the SharkCore™ needle were placed in a single container of formaldehyde and sent for histological analysis. On-site sample evaluation was not performed. Samples were reported by expert cytopathologists and histopathologists respectively who were blinded to the results of the other needle. Only samples reported as diagnostic of malignancy were considered positive. Inadequate samples were not excluded from the analysis. Sample quality and ease of diagnosis were assessed on a 3 point scale. The primary endpoint was the accuracy of the diagnosis of malignancy. Secondary endpoints were the quality of sample obtained, ease of diagnosis and the duration of tissue sampling and pathological reporting. Results: 108 participants were recruited, 57 male; mean age 66.9 ± 10.9. 85.2% had a final diagnosis of malignancy. Median lesion size (IQR)was 25mm (19-34.5). 62 (57.4%)of lesions were in the head of pancreas. Tissue results from the FNB needle were significantly more accurate than FNA (84.2% vs 75%, p=0.041)in discriminating malignant from benign masses. A greater proportion of FNB samples had abundant diagnostic material (59.2% vs 44.4%, p=0.017)and a straight forward diagnosis (68.9% vs 51.9%, p=0.03). Biopsy sampling time median (IQR)685s (565-832)vs 752s (651-835), p=0.0006)and pathology reporting times (191s (134-258)vs 332s (260-358), p< 0.0001)were significantly shorter with FNB compared to FNA. Conclusion: The diagnostic performance of the SharkCore™ FNB needle was significantly better than that of a standard FNA needle in the diagnosis of solid pancreatic masses and was associated with better sample quality, ease of reporting and shorter sampling and pathological reporting times.