- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07714941
EUS-Guided ATI and SWE in Individuals With Normal FibroScan (EUS ATI&SWE)
"EUS-Guided Attenuation Imaging and Shear Wave Elastography in Individuals With Normal FibroScan: Establishing Preliminary Reference Values in a Pilot Feasibility Study".
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
The primary outcome of the study is to establish preliminary reference values for EUS-guided ATI, SWE elasticity (kPa), and SWE velocity (m/s) for both hepatic lobes. Secondary objectives include evaluating the technical feasibility and reliability of EUS-guided quantitative liver assessment, assessing agreement between right and left hepatic lobe measurements, determining correlations between ATI and FibroScan CAP, evaluating correlations between SWE and FibroScan LSM, and documenting acquisition times for both techniques.
The findings from this pilot study will provide foundational reference data for EUS-guided quantitative liver imaging and support the design of larger validation studies investigating the role of EUS-guided ATI and SWE in the diagnosis and monitoring of hepatic steatosis and fibrosis.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Aig research
- Número de telefone: +919182645727
- E-mail: aigresearch7@gmail.com
Locais de estudo
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Telangana
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Hyderabad, Telangana, Índia, 500032
- AIG Hospitals
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Contato:
- Aig research, MD, DM
- Número de telefone: 09182645727
- E-mail: aigresearch7@gmail.com
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Investigador principal:
- Dr. Sundeep Lakhtakia, MD, DM
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Subinvestigador:
- Dr. Anudeep Katrevula, MD, DM
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Subinvestigador:
- Dr. Jahangeer Basha, MD, DM
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Known chronic liver disease.
- Hepatitis B or Hepatitis C infection.
- Significant alcohol consumption.
- Decompensated cirrhosis.
- Portal vein thrombosis.
- Ascites.
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Normal FibroScan Cohort
Adults aged 18 years or older undergoing clinically indicated diagnostic endoscopic ultrasound (EUS) for non-hepatobiliary indications who have normal FibroScan findings (Controlled Attenuation Parameter [CAP] <238 dB/m and Liver Stiffness Measurement [LSM] <7.5 kPa).
Participants will undergo EUS-guided Attenuation Imaging (ATI) and Shear Wave Elastography (SWE) of the right and left hepatic lobes during the same EUS procedure to establish preliminary reference values and assess the feasibility and reliability of these quantitative imaging techniques.
|
A clinically indicated diagnostic endoscopic ultrasound will be performed according to standard institutional practice.
During the examination, the liver will be visualized from the stomach and duodenum to allow quantitative liver assessment.
Attenuation Imaging (ATI) will be performed during the diagnostic EUS to quantitatively assess hepatic steatosis.
Five valid ATI measurements will be obtained from both the right and left hepatic lobes under direct EUS visualization.
Measurements meeting predefined quality criteria will be used for analysis.
Shear Wave Elastography (SWE) will be performed during the diagnostic EUS to assess liver stiffness.
Ten valid measurements will be obtained from both the right and left hepatic lobes.
Shear wave velocity (m/s) and tissue elasticity (kPa) will be recorded, and only measurements meeting predefined quality criteria will be included in the analysis.
Participants will undergo same-day FibroScan examination before EUS to confirm normal liver stiffness and steatosis.
Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM) will be recorded, with at least 10 valid measurements and acceptable quality metrics required for study eligibility.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Reference values for EUS-guided Attenuation Imaging (ATI)
Prazo: During the index EUS procedure (Day 0)
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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.
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During the index EUS procedure (Day 0)
|
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Reference values for EUS-guided Shear Wave Elastography (SWE) elasticity
Prazo: 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.
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During the index EUS procedure (Day 0)
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Reference values for EUS-guided Shear Wave Elastography (SWE) velocity
Prazo: During the index EUS procedure (Day 0)
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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.
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During the index EUS procedure (Day 0)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Technical success rate
Prazo: During the index EUS procedure (Day 0)
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To determine the proportion of participants in whom acceptable EUS-guided ATI and SWE measurements are successfully acquired according to predefined quality criteria.
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During the index EUS procedure (Day 0)
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Measurement reliability
Prazo: During the index EUS procedure (Day 0)
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To evaluate the reliability and reproducibility of EUS-guided ATI and SWE measurements using predefined quality parameters.
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During the index EUS procedure (Day 0)
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Agreement between right and left hepatic lobe measurements
Prazo: During the index EUS procedure (Day 0)
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To assess agreement between ATI and SWE measurements obtained from the right and left hepatic lobes.
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During the index EUS procedure (Day 0)
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Correlation between ATI and FibroScan CAP
Prazo: During the index EUS procedure (Day 0)
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To evaluate the correlation between EUS-guided ATI measurements and FibroScan Controlled Attenuation Parameter (CAP).
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During the index EUS procedure (Day 0)
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Correlation between SWE and FibroScan Liver Stiffness Measurement (LSM)
Prazo: During the index EUS procedure (Day 0)
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To evaluate the correlation between EUS-guided SWE measurements and FibroScan Liver Stiffness Measurement (LSM).
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During the index EUS procedure (Day 0)
|
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Acquisition time
Prazo: During the index EUS procedure (Day 0)
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To determine the time required to complete EUS-guided ATI and SWE measurements during the diagnostic EUS examination.
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During the index EUS procedure (Day 0)
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doenças do aparelho digestivo
- Doenças do Fígado
- Fibrose
- Condições Patológicas, Sinais e Sintomas
- Cirrose hepática
- Técnicas de investigação
- Manipulação de amostras
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Procedimentos cirúrgicos, operatórios
- Procedimentos cirúrgicos minimamente invasivos
- Técnicas citológicas
- Biópsia
- Citodiagnóstico
- Técnicas de diagnóstico, cirúrgico
- Diagnóstico imagens
- Ultrassonografia
- Biópsia, agulha fina
- Biópsia, agulha
- Biópsia guiada por imagem
- Ultrassonografia, intervencional
- Aspiração endoscópica de agulha fina guiada por ultrassom
Outros números de identificação do estudo
- EUS-ATI&SWE
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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