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.

中文翻译：

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EUS 引导与经皮肝活检：一项前瞻性随机临床试验。

背景和目的 比较 EUS 引导肝活检 (EUS-LB) 与经皮 LB (PC-LB) 的前瞻性研究很少。我们在一项前瞻性随机临床试验中比较了 EUS-LB 与 PC-LB 的疗效和安全性。方法 2020 年至 2021 年间，患者被入组并随机化（1:1 比例）。主要结局定义为具有 ≥11 个完整汇管束 (CPT) 的患者比例。样本量 (n = 80) 的计算基于以下假设：EUS-LB 组中 60% 的患者和 PC-LB 组中 90% 的 LB 具有 ≥11 CPT。次要结局包括确诊患者的比例、CPT 次数、疼痛严重程度（数字评定量表-疼痛强度）、住院时间和不良事件。结果 80 名患者入组（中位年龄 53 岁）；67.5%为女性。EUS-LB 组中 60% 的患者和 PC-LB 组中 75.0% 的患者达到主要结局（P = 0.232）。PC-LB 中 CPT 的中位数较高（17 比 13；P = 0.031）。各组之间确诊的患者比例相似（92.5% [EUS-LB] vs 95.0% [PC-LB]；P = 1.0）。与 PC-LB 组相比，EUS-LB 组患者的疼痛严重程度较低（中位数字评定量表-疼痛强度，2.0 vs 3.0；P = 0.003），住院时间较短（2.0 vs 4.0 小时；P < 0.0001）。没有患者出现严重不良事件。结论 EUS 引导下的肝活检安全、有效、耐受性更好，并且住院时间更短。