"EUS-Guided Attenuation Imaging and Shear Wave Elastography in Individuals With Normal FibroScan: Establishing Preliminary Reference Values in a Pilot Feasibility Study".
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reference values for EUS-guided Attenuation Imaging (ATI)
研究概览
简要总结
The goal of this observational study is to establish preliminary reference values for Endoscopic Ultrasound (EUS)-guided Attenuation Imaging (ATI) and Shear Wave Elastography (SWE) in adults undergoing diagnostic EUS for non-hepatobiliary indications who have normal FibroScan findings. The main questions it aims to answer are:
What are the preliminary normal reference values for EUS-guided ATI in the right and left hepatic lobes? What are the preliminary normal reference values for EUS-guided SWE elasticity (kPa) and velocity (m/s) in the right and left hepatic lobes?
Participants will:
Undergo same-day FibroScan assessment to confirm normal liver stiffness and steatosis parameters.
Undergo EUS-guided ATI and SWE measurements of both the right and left hepatic lobes during their clinically indicated diagnostic EUS examination.
Have demographic, clinical, and laboratory information recorded for analysis.
详细描述
Vibration-controlled transient elastography (FibroScan) with Liver Stiffness Measurement (LSM) and Controlled Attenuation Parameter (CAP) is widely used for the non-invasive assessment of liver fibrosis and steatosis. Although these techniques have demonstrated good diagnostic performance, they have several limitations, including technical failure in obese individuals, reduced accuracy in the presence of ascites or narrow intercostal spaces, and the inability to obtain real-time image-guided measurements from specific areas of the liver.
Endoscopic ultrasound (EUS) provides high-resolution imaging of both hepatic lobes through the stomach and duodenum, allowing quantitative assessment of liver tissue under direct visualization. Recent advances have enabled the integration of Attenuation Imaging (ATI), which quantifies hepatic steatosis, and Shear Wave Elastography (SWE), which measures liver stiffness by estimating tissue elasticity and shear wave velocity, into EUS platforms. These techniques may overcome several limitations of conventional transabdominal elastography and have the potential to provide more reliable liver tissue characterization.
Before EUS-guided ATI and SWE can be evaluated as diagnostic tools for liver disease, normal reference values in individuals without liver disease must be established. Currently, there are limited data regarding normal EUS-guided ATI and SWE measurements, particularly in healthy adults with normal FibroScan findings. Establishing these reference ranges is essential for interpreting future studies involving patients with hepatic steatosis and chronic liver disease.
This prospective, single-center, observational pilot feasibility study aims to establish preliminary reference values for EUS-guided ATI and SWE in adults undergoing diagnostic EUS for non-hepatobiliary indications who have normal FibroScan examinations. A total of 100 participants will be enrolled after confirming normal liver stiffness (LSM <7.5 kPa) and steatosis (CAP <238 dB/m), along with adequate FibroScan quality criteria.
During the clinically indicated EUS examination, quantitative liver assessment will be performed without introducing additional invasive procedures beyond standard EUS. Attenuation Imaging will be obtained from both the right and left hepatic lobes, with five valid measurements acquired per lobe. Shear Wave Elastography will also be performed in both lobes, with ten valid measurements obtained per lobe. Measurements will be accepted only if predefined quality criteria are met, including acceptable correlation coefficients, propagation maps, and reliability indices. Acquisition time, technical success, and measurement reproducibility will also be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Undergoing clinically indicated diagnostic endoscopic ultrasound (EUS).
- •Same-day FibroScan examination available.
- •Controlled Attenuation Parameter (CAP) <238 dB/m.
- •Liver Stiffness Measurement (LSM) <7.5 kPa.
- •At least 10 valid FibroScan measurements.
- •FibroScan interquartile range (IQR)/median ≤30%.
- •Able and willing to provide written informed consent.
排除标准
- •Known chronic liver disease.
- •Hepatitis B or Hepatitis C infection.
- •Significant alcohol consumption.
- •Decompensated cirrhosis.
- •Portal vein thrombosis.
- •Focal liver lesion.
- •Previous liver surgery.
- •Pregnancy.
- •Inadequate FibroScan examination.
- •Poor-quality EUS-guided Attenuation Imaging (ATI) or Shear Wave Elastography (SWE) acquisition.
- •Incomplete study data or withdrawal of informed consent.
结局指标
主要结局
Reference values for EUS-guided Attenuation Imaging (ATI)
时间窗: During the index EUS procedure (Day 0)
To establish preliminary reference values for EUS-guided Attenuation Imaging (ATI) in the right and left hepatic lobes of adults with normal FibroScan findings. ATI values will be reported as mean ± standard deviation (SD), median (interquartile range \[IQR\]), and 95% reference intervals.
Reference values for EUS-guided Shear Wave Elastography (SWE) elasticity
时间窗: During the index EUS procedure (Day 0)
To establish preliminary reference values for EUS-guided SWE elasticity (kPa) in the right and left hepatic lobes. Results will be reported as mean ± SD, median (IQR), and 95% reference intervals.
Reference values for EUS-guided Shear Wave Elastography (SWE) velocity
时间窗: During the index EUS procedure (Day 0)
To establish preliminary reference values for EUS-guided SWE shear wave velocity (m/s) in the right and left hepatic lobes. Results will be reported as mean ± SD, median (IQR), and 95% reference intervals.
次要结局
- Technical success rate(During the index EUS procedure (Day 0))
- Measurement reliability(During the index EUS procedure (Day 0))
- Agreement between right and left hepatic lobe measurements(During the index EUS procedure (Day 0))
- Correlation between ATI and FibroScan CAP(During the index EUS procedure (Day 0))
- Correlation between SWE and FibroScan Liver Stiffness Measurement (LSM)(During the index EUS procedure (Day 0))
- Acquisition time(During the index EUS procedure (Day 0))
研究者
Mohan Ramchandani
Consultant Gastroenterology
Asian Institute of Gastroenterology, India
