EUS–guided versus percutaneous liver biopsy: A prospective randomized clinical trial
Ahmad H. Ali, Naren S. Nallapeta, Muhammad Nadeem Yousaf, Gregory F. Petroski, Neal Sharma, Deepthi Rao, Feng Yin, Ryan M. Davis, Ambarish P. Bhat, Ahmed Swi, Alhareth Al-Juboori, Jamal A. Ibdah, Ghassan M. Hammoud
Abstract
ABSTRACT Background and Objectives Prospective studies comparing EUS–guided liver biopsy (EUS-LB) to percutaneous LB (PC-LB) are scarce. We compared the efficacy and safety of EUS-LB with those of PC-LB in a prospective randomized clinical trial. Methods Between 2020 and 2021, patients were enrolled and randomized (1:1 ratio). The primary outcome was defined as the proportion of patients with ≥11 complete portal tracts (CPTs). The sample size (n = 80) was calculated based on the assumption that 60% of those in the EUS-LB and 90% of those in the PC-LB group will have LB with ≥11 CPTs. The secondary outcomes included proportion of patients in whom a diagnosis was established, number of CPTs, pain severity (Numeric Rating Scale—Pain Intensity), duration of hospital stay, and adverse events. Results Eighty patients were enrolled (median age, 53 years); 67.5% were female. Sixty percent of those in the EUS-LB and 75.0% of those in the PC-LB group met the primary outcome ( P = 0.232). The median number of CPTs was higher in the PC-LB (17 vs 13; P = 0.031). The proportion of patients in whom a diagnosis was established was similar between the groups (92.5% [EUS-LB] vs 95.0% [PC-LB]; P = 1.0). Patients in the EUS-LB group had less pain severity (median Numeric Rating Scale—Pain Intensity, 2.0 vs 3.0; P = 0.003) and shorter hospital stay (2.0 vs 4.0 hours; P < 0.0001) compared with the PC-LB group. No patient experienced a serious adverse event. Conclusions EUS–guided liver biopsy was safe, effective, better tolerated, and associated with a shorter hospital stay.