Ahmad H Ali, Naren S Nallapeta, Muhammad N Yousaf, Gregory F Petroski, Neal Sharma, Deepthi S Rao, Feng Yin, Ryan M Davis, Ambarish Bhat, Ahmed I A Swi, Alhareth Al-Juboori, Jamal A Ibdah, Ghassan M Hammoud
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引用次数: 0
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.
背景和目的：比较EUS引导的肝活检（EUS-LB）和经皮肝活检（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和PC-LB的疗效和安全性。方法：在2020年至2021年期间，患者被纳入并随机分组（1:1比例）。主要转归定义为具有≥11个完整门静脉束（CPT）的患者比例。样本量（n=80）是基于以下假设计算的：EUS-LB组中60%的患者和PC-LB组中90%的患者将患有具有≥11个CPT的LB。次要结果包括确诊患者的比例、CPT的数量、疼痛严重程度（疼痛强度数值评定量表）、住院时间和不良事件。结果：80名患者入选（中位年龄53岁）；女性占67.5%。EUS-LB组中60%的患者和PC-LB组中75.0%的患者符合主要结果（P=0.232）。PC-LB组的CPT中位数更高（17对13；P=0.031）。两组之间确诊的患者比例相似（92.5%[EUS-LB]对95.0%[PC-LB]；P=1.0）（中位数值评定量表疼痛强度，2.0 vs 3.0；P=0.003），住院时间更短（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引导下肝活检安全、有效、耐受性好，住院时间短。
期刊介绍：
Endoscopic Ultrasound, a publication of Euro-EUS Scientific Committee, Asia-Pacific EUS Task Force and Latin American Chapter of EUS, is a peer-reviewed online journal with Quarterly print on demand compilation of issues published. The journal’s full text is available online at http://www.eusjournal.com. The journal allows free access (Open Access) to its contents and permits authors to self-archive final accepted version of the articles on any OAI-compliant institutional / subject-based repository. The journal does not charge for submission, processing or publication of manuscripts and even for color reproduction of photographs.
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