Background and Objective: Endoscopic ultrasound (EUS) guided fine-needle biopsy (FNB) to obtain core liver specimen has been shown to be effective and safe. However, prospective data is limited regarding EUS-FNB in non-malignant liver disease. The objective of this study is to evaluate two EUS-FNB techniques, modified wet suction (MWS) versus slow pull (SP), in patients with non- malignant liver disease. Methods: In this prospective, randomized controlled trial we are evaluating efficacy and safety of EUS-FNB techniques (MWS versus SP) using a 19-gauge needle in patients with initial indication for an upper endoscopy plus need for a liver biopsy to assess non-malignant disease. The primary outcome is pathological yield defined as number of complete portal tracts (CPTs), specimen length, and fragmentation. Secondary outcomes include pathological yield between two separate specimen processing techniques, pathological yield between left versus right liver lobe biopsy, time for biopsy technique, and complications 1 week post-biopsy. Results: For this interim analysis, 8 patients (5 received MWS and 3 received SP) out of a projected total of 360 patients are enrolled. Independent t-test analysis reveals no statistical difference between CPTs (P=0.56), specimen length (P=0.12), and fragmentation (P=0.16). No differences are found between any secondary outcomes, and there have been no complications attributed to the biopsy.
Conclusion: This underpowered interim analysis reveals no statistical difference in primary or secondary outcomes between MWS versus SP technique. The current results for both groups are consistent with specimen adequacy criteria determined by American Association for the Study of Liver Disease.
IU School of Medicine Student Research Fellowship Program
Rumancik, Brad PharmD, "Comparison of 2 Techniques Using EUS Guided Liver Biopsies Via 19 Gauge Core Needle to Obtain Optimal Core Specimen in Benign Disease (BLOCS - Benign Liver Optimal Core Study)" (2018). Graduate and Medical Student Research. 1.