EUS-guided biopsy using 19-gauge Franseen needle versus percutaneous ultrasound-guided biopsy using 18-gauge full-core cutting needle for parenchymal liver disease: A randomized controlled, non-inferiority trial.
Ishank Johri, Vikram Bhatia, Amar Mukund, Archana Rastogi, Chaggan Bihari, Srajit Singh, Rajan Vijayaraghavan, Phool Chand, Jaifrin Daniel
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引用次数: 0
Abstract
Background and aims: There is limited data comparing endoscopic ultrasound-guided liver biopsy (EUS-LB) with percutaneous ultrasound-guided liver biopsy (PC-LB) regarding tissue adequacy, histologic yield, adverse events, and patient satisfaction.
Methods: In this single-center, parallel-group, non-inferiority trial, we randomized participants 1:1 to EUS-LB (19-G Franseen-tip biopsy needle; modified wet-heparin suction; left and/or right lobe) or PC-LB (18-G BioPince™ full-core needle; right lobe). The primary endpoint was specimen adequacy, defined as total specimen length (TSL) ≥15 mm and complete portal tracts (CPT) ≥8. Non-inferiority was assessed using absolute risk difference with a prespecified margin of -10%.
Results: Ninety participants were randomized. In intention-to-treat analysis, the primary endpoint was achieved in 44/45(97.8%) of EUS-LB and 29/45(64.4%) of PC-LB group (risk difference +33.3%; 95%CI: +17.9% to +48.1%), meeting non-inferiority and demonstrating superiority (p<0.001). With EUS-LB and PC-LB, the median TSL was 6.9cm versus 2.0cm and the median CPT number was 42 versus 9, respectively (both p<0.001). Even a single pass of EUS-LB outperformed PC-LB, with respect to sample adequacy, TSL, total CPT, and biopsy area (all p<0.001). PC-LB specimens were less fragmented (median 1 vs 13; p<0.001) and had greater median width (747.8μm vs. 667.2μm; p<0.001). Adverse events occurred more frequently with EUS-LB (26.7% vs. 4.4%; p=0.007); all but one were minor. Post-procedural pain was minimal, and satisfaction ratings were high in both groups.
Conclusions: EUS-LB was non-inferior and superior to PC-LB for the prespecified adequacy endpoint, yielding substantially greater specimen length and CPT counts, with more frequent but predominantly minor adverse events.
背景和目的：比较内镜下超声引导下肝活检（EUS-LB）和经皮超声引导下肝活检（PC-LB）在组织充分性、组织学产量、不良事件和患者满意度方面的数据有限。方法：在这项单中心、平行组、非效性试验中，我们将参与者1:1随机分配到EUS-LB （19 g Franseen-tip活检针；改良的湿肝素吸吸；左和/或右肺叶）或PC-LB （18 g BioPince™全芯针；右肺叶）。主要终点是标本充足性，定义为总标本长度(TSL)≥15 mm，完整门脉束(CPT)≥8。非劣效性评估采用绝对风险差，预先规定的边际为-10%。结果：90名参与者被随机化。在意向治疗分析中，44/45（97.8%）的EUS-LB和29/45（64.4%）的PC-LB组达到了主要终点（风险差异+33.3%;95%CI: +17.9%至+48.1%），符合非劣效性并显示出优势(p结论：EUS-LB在预先指定的充分性终点上不劣于PC-LB，且优于PC-LB，产生更大的标本长度和CPT计数，更常见但主要是轻微的不良事件。试验报名：CTRI/2023/10/058529；NCT06047327。
期刊介绍：
Gastrointestinal Endoscopy is a journal publishing original, peer-reviewed articles on endoscopic procedures for studying, diagnosing, and treating digestive diseases. It covers outcomes research, prospective studies, and controlled trials of new endoscopic instruments and treatment methods. The online features include full-text articles, video and audio clips, and MEDLINE links. The journal serves as an international forum for the latest developments in the specialty, offering challenging reports from authorities worldwide. It also publishes abstracts of significant articles from other clinical publications, accompanied by expert commentaries.
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