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临床试验/NCT05728697
NCT05728697招募中不适用

Endoscopic Ultrasound Shear Wave Elastography: A Novel Tool for Fibrosis Screening in Patient With Elevated Body Mass Index and Suspected Non-Alcoholic Fatty Liver Disease or Steatohepatitis

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
Optimal stiffness cutoffs for EUS-SWE based on AUROC analysis

研究概览

简要总结

The goal of this observation study is to assess whether endoscopic ultrasound shear wave elastography (EUS-SWE) may be a useful tool for liver fibrosis screening in patients with elevated body mass index and non alcoholic fatty liver disease as compared to other non-invasive screening modalities, which have traditionally had less accurate results in this population.

The main questions it aims to answer are:

  • Determine accuracy of EUS-SWE for liver fibrosis screening compared to other non-invasive scoring systems, such as the FIB-4 score and Fibroscan in patients with elevated body mass index
  • Establish optimal stiffness (kPa) cutoffs for liver fibrosis grading for EUS-SWE for this patient population in reference to the gold standard liver biopsy, as no standard cutoffs currently exist.

Participants will undergo routine endoscopic ultrasound as part of their standard clinical care and indication. Participants are consented for the procedure and undergoing the shear wave elastography. In addition to their standard ultrasound test, it takes on average an extra 2-3 minutes to perform the shear wave elastography. The procedure itself adds no additional risk to the patient and does not expose them to radiation.

详细描述

Introduction:

Non-alcoholic fatty liver disease (NAFLD) is the most widespread chronic liver condition across the world. NAFLD over time can progress to its more severe form, non-alcoholic steatohepatitis (NASH), which is associated with increased speed of progression to advanced fibrosis and cirrhosis. Identification of patients with suspected NAFLD/NASH and early stage fibrosis is crucial for prompt clinical management in weight loss and optimization of metabolic disorders for reversal of fibrosis, but the gold standard of liver biopsy can be impractical due to high costs and risk of sampling error and procedural complications.

Elastography is a non-invasive imaging modality that provides information about tissue elasticity and is often used to measure liver stiffness as a correlation to fibrosis severity (F0-4). Elastography has been heralded as a promising alternative to liver biopsies given its non-invasive nature and improved cost effectiveness in the general population. Many elastography modalities exist, including Fibroscan, magnetic resonance elastography (MRE), and shear wave elastography (SWE).

Unfortunately, despite being highly sensitive and specific, routine MRE for NAFLD/NASH fibrosis screening can also be cost prohibitive. Fibroscan and SWE are more cost effective and are routinely performed via a transabdominal probe for liver fibrosis screening in patients with NAFLD/NASH, but their accuracy may be impeded in patients with obesity.

Endoscopic ultrasound (EUS) approaches to elastography may hold several technical advantages over transabdominal in patients with obesity due to EUS-SWE's ability to visualize the liver parenchyma under a thin sub-centimeter gastric or duodenal wall, unlike transabdominal approaches in which the quality may be impacted by a thick abdominal wall. The main disadvantage to EUS-SWE, however, is that it is a fairly novel technology with no established stiffness cutoffs for the various fibrosis grades, unlike VCTE of which fibrosis grade cutoffs are well studied and standardized for patients with NAFLD/ NASH.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Adults 18 years or older
  • Planned for clinically indicated endoscopic ultrasound with plan for follow up liver biopsy
  • Suspected or confirmed non alcoholic fatty liver disease prior to procedure
  • Body mass index >=25

排除标准

  • Inadequate liver biopsy sample

研究组 & 干预措施

Patients with nonalcoholic fatty liver disease and elevated body mass index

Patients who have BMI >=25 and suspected nonalcoholic fatty liver disease based on imaging, laboratory workup, or clinical history. Patients are included in the study if they have been selected for routine clinical endoscopic ultrasound (can be for any indication) with liver biopsy either during the same session or within 6 months.

干预措施: Endoscopic ultrasound shear wave elastography (Device)

结局指标

主要结局

Optimal stiffness cutoffs for EUS-SWE based on AUROC analysis

时间窗: Up to 6 months

Optimal cutoffs can be derived with the Youden index in attempt to maximize sensitivity and specificity

Accuracy of EUS-SWE in reference to the gold standard liver biopsy

时间窗: Up to 6 months

Accuracy is measured by performing area under the receiver operator characteristic (AUROC) analysis for different threshold of liver fibrosis (e.g. advanced fibrosis, cirrhosis). The AUROC c-statistic number will then be statistically compared to other non-invasive modalities, such as FIB-4 and Fibroscan who will have similar AUROC curves generated as surrogate for accuracy.

次要结局

未报告次要终点

研究者

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

Marvin Ryou

Director of Endoscopic Innovation

Brigham and Women's Hospital

研究点 (2)

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