EUS-Guided ATI and SWE in Individuals With Normal FibroScan (NCT07714941) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
EUS-Guided ATI and SWE in Individuals With Normal FibroScan
India100 participantsStarted 2026-08-20
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reference values for EUS-guided Attenuation Imaging (ATI)
Timeframe: During the index EUS procedure (Day 0)
2
Reference values for EUS-guided Shear Wave Elastography (SWE) elasticity
Timeframe: During the index EUS procedure (Day 0)
3
Reference values for EUS-guided Shear Wave Elastography (SWE) velocity