Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in MASLD Related C… (NCT05044663) | Clinical Trial Compass
CompletedNot Applicable
Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in MASLD Related Compensated Advanced Chronic Liver Disease.
India325 participantsStarted 2021-09-18
Plain-language summary
Patients with chronic liver disease (CLD) are at risk of developing clinically significant portal hypertension (CSPH). In the Baveno VI consensus a new term "compensated advanced chronic liver disease (cACLD)'' has been proposed to better reflect that the spectrum of severe fibrosis and cirrhosis is a continuum in asymptomatic patients. Liver stiffness by TE is sufficient to suspect cACLD in asymptomatic subjects with known causes of CLD. TE values \<10 kPa in the absence of other known clinical signs rule out cACLD; values between 10 and 15 kPa are suggestive of cACLD but need further test for confirmation; values \>15 kPa are highly suggestive of cACLD. Patients with a liver stiffness \<20 kPa and with a platelet count \>150,000 have a \< 5 % risk of having varices requiring treatment, and can avoid screening endoscopy. SSM can also predict the presence of CSPH and varices requiring treatment. Because of restrictive nature of Baveno VI, recent Baveno VII guidelines state that patients not satisfying Baveno VI criterai acan have endoscopy avoided if their spleen stiffness is less than 40kPa. Some studies have shown superiority of splenic stiffness over liver stiffness in predicting varices requiring treatment likely attributable to the better performance of SSM compared with LSM in more severe portal hypertension because it reflects better the hemodynamic component of portal hypertension. However, there are few studies on MASLD and most are on viral hepatitis related cACLD. Moreover, very few studies are published on splenic stiffness from Indian subcontinent. Hence, we intend to do the study assessing diagnostic utility of splenic and liver stiffness and validate the Baveno VII algorothm in predicting varices needing treatment in MASLD related cACLD and compare from other noninvasive markers.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
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Inclusion criteria
. Waist circumference 90 ≥ cm for males or ≥80 cm for females
. Triglycerides ≥150 mg/dL
. HDL-C \< 40 mg/dL in males or \< 50 mg/dl in females
. systolic blood pressure (SBP) ≥130 mm Hg or diastolic blood pressure (DBP) ≥ 85 mmHg or both and
. Fasting plasma glucose ≥ 100 mg/dL. cACLD is defined with Liver stiffness ≥10 kPa. Ultrasound examination, blood examination and upper gastrointestinal endoscopy will be performed within 1 month of Fibroscan examination. HVPG if indicated will be done within 1 month of Fibroscan.
Exclusion criteria
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?
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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
Utility of BAVENO 7 criteria to predict presence of esophageal varices needing treatment in patients of MASLD related cACLD.
Timeframe: Day 0
Trial details
NCT IDNCT05044663
SponsorInstitute of Liver and Biliary Sciences, India