EUS-guided versus percutaneous liver biopsy: A prospective randomized clinical trial

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.

Keywords: Complete portal tracts; EUS; Efficacy; Fine needle biopsy; Histological diagnosis; Liver biopsy; Percutaneous; Safety.

Figure 1

A, Linear regression showing the relationship between the number of complete portal tracts and the total length of LB core in the entire cohort. B, Number of complete portal tracts and total length of LB core in the PC-LB group. C, Number of complete portal tracts and total length of LB core in the EUS-LB group. D, Number of complete portal tracts and the number of passes in the entire cohort. E, Number of complete portal tracts and the number of passes in the PC-LB group. F, Number of complete portal tracts and the number of passes in the EUS-LB group. The blue line represents the regression fit line, and the gray shaded area represents the 95% confidence interval. EUS-LB, EUS–guided liver biopsy; LB, liver biopsy; PC-LB, percutaneous liver biopsy.

Figure 2

An illustration of a comparison and the relationship between the medians of number of complete portal tracts and the number of passes in the PC-LB and EUS-LB groups. The lower and upper bar lines represent the minimum and maximum, respectively. The line inside each bar represents the median. The blue line represents the primary outcome reference line, that is, 11 complete portal tracts. EUS-LB, EUS–guided liver biopsy; PC-LB, percutaneous liver biopsy.