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临床试验/NCT05295537
NCT05295537已完成不适用

Prospective, Randomized, Comparative, Non-inferiority, Multicentre Trial of Quality of Samples Obtained by Percutaneous Liver Biopsy Versus Endoscopic Ultrasound-guided Liver Biopsy

Hospital Clinico Universitario de Santiago2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2022年1月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
2
主要终点
Quality of tissue samples obtained by EUS-guided liver biopsy compared to percutaneous liver biopsy.

研究概览

简要总结

Although the use of liver biopsy (LB) has decreased with the emerging non-invasive markers and techniques to evaluate liver fibrosis, histopathologic examination of liver tissue is necessary to confirm the type of liver injury. The aim of our study is to compare two methods for obtaining histological material from the liver: the percutaneous liver biopsy (PLB) and the Endoscopic ultrasound (EUS) guided liver biopsy (EUS-LB)

详细描述

LB remains the gold standard diagnostic test for most of the focal and parenchymal liver diseases. LB has an important diagnostic role in selected parenchymal liver diseases such as autoimmune hepatitis and infiltrative liver disorders, and in some cases, it helps clinicians to elucidate between overlapping diagnoses Traditionally, percutaneous (PLB) or transjugular approaches have been used to acquire liver samples. In recent tears EUS has emerged as an alternative and safe method to obtain liver samples, by puncturing the liver from the gastric or duodenal wall. In fact, EUS-guided LB has been shown equal or superior compared to PLB and transjugular approaches in retrospective series. EUS - LB has shown to produce excellent histological performance based on liver society guidelines requirements for parameters used in assessing histological yield which include the number of complete portal triads (CPT), sample size and total specimen length (TSL) with a low rate of adverse events EUS - LB has several advantages over the traditional liver biopsy methods: it provides simultaneous access to both liver lobes, enables real-time visualization avoiding the puncture of a large vessel and then reducing the rate of complications, it allows to perform a simultaneously endoscopic and endosonography evaluation of the pancreatobiliary system and it could decrease the level of the anxiety of patients (by the use of deep sedation) and then perhaps increasing the satisfaction with the procedure Despite the fact of the high diagnostic yield of EUS-LB in obtaining adequate samples from the liver and the low rate of adverse events reported with this method, there is an almost complete lack of randomized trials comparing EUS - LB with the traditional percutaneous route.

The aim of our study is to compare the quality of samples obtained and the diagnostic efficacy of EUS - LB against PLB in all patients that have an indication for a liver biopsy

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 18 years, any gender
  • Understanding and informed consent signed
  • Fit for deep sedation

排除标准

  • Age below 18 years
  • Not signed informed consent
  • Contraindication for a deep sedation
  • Pregnancy
  • Focal liver lesion that requires biopsy visualized by other imaging techniques
  • Coagulopathy (INR>1.5 or platelets < 50,000)
  • Inability to withdraw anticoagulant or antithrombotic agents

结局指标

主要结局

Quality of tissue samples obtained by EUS-guided liver biopsy compared to percutaneous liver biopsy.

时间窗: Up to 2 weeks

The quality of samples is based in the combination of a specimen length \>20 mms and more than 10 complete portal triads (both conditions are required).

次要结局

  • Diagnostic accuracy of EUS-guided liver biopsy compared to percutaneous liver biopsy.(Up to 2 weeks)
  • Patient satisfaction after EUS-guided liver biopsy compared to percutaneous liver biopsy.(24 hours)
  • Adverse events associated with EUS-guided liver biopsy compared to percutaneous liver biopsy.(At 1 hour, 4 hours, 24 hours, 7 days, and 30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

J. Enrique Domínguez-Muñoz

Director of the Department of Gastroenterology

Hospital Clinico Universitario de Santiago

研究点 (2)

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