Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in MASLD Related Compensated Advanced Chronic Liver Disease.

January 8, 2026 updated by: Institute of Liver and Biliary Sciences, India

Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in MASLD Related Compensated Advanced Chronic Liver Disease - A Cross-Sectional Study.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

Aim - to study the diagnostic accuracy of liver stiffness and splenic stiffness in predicting esophageal varices needing treatment in patients of NASH related cACLD.

Primary objective:

To assess the utility of liver stiffness and splenic stiffness in making a composite score to predict presence of esophageal varices needing treatment in patients of NASH related cACLD.

Secondary objectives:

  1. To study the correlation of liver stiffness and splenic stiffness with grade of esophageal varices.
  2. To study utility of other noninvasive scores, such as Baveno VI criteria, expanded Baveno VI criteria, LSPS (LS x spleen diameter / platelet ratio score), platelet count to spleen diameter ratio (PSR), AST/ALT ratio, APRI, FIB-4, in predicting presence of esophageal varices needing treatment in patients of NASH related cACLD.
  3. To study utility of noninvasive tests in predicting presence of esophageal varices needing treatment in patients of HBV or HCV related cACLD.

  4. To study correlation of liver and splenic stiffness with HVPG and MELD score in patients of NASH related cACLD.

    (b) Methodology:

    • Study population: Consecutive patients of NASH related cACLD (Liver Stiffness ≥10 kPa).

Consecutive patients of viral hepatitis (HBV / HCV) related cACLD during the study period meeting the inclusion and exclusion criteria will be taken as control.

  • Study design: An observational cross-sectional study
  • Study period: 15 months
  • Sample size with justification: This is a cross-sectional prevalence study. All the patients meeting the inclusion and exclusion criteria during the period October 2021 to December 2022 undergoing liver stiffness, splenic stiffness and upper gastrointestinal endoscopy will be included in the study.
  • Intervention: Patients of NASH related cACLD and controls (viral hepatitis related cACLD) will undergo upper gastrointestinal endoscopy, liver and splenic stiffness measurement, ultrasound abdomen, Doppler study and routine laboratory tests. Varices needing treatment will be defined by Baveno VI criteria as medium or large size esophageal varices or the presence of high-risk stigmata findings (red wale marks, cherry red spots). HVPG will be done in the patients only if clinically indicated.
  • Monitoring and assessment: Transient Elastography will be performed in morning hours using the FibroScan apparatus (Echosens), which consists of a 5-MHz ultrasound transducer probe mounted on the axis of a vibrator. The tip of the transducer (M-or XL probe) will be placed perpendicularly in the intercostal space, with the patient lying in dorsal decubitus position with the right arm in the maximal abduction. The operator will choose a liver portion within the right liver lobe, at least 6-cm thick and free of large vascular structures, and the gallbladder. Liver stiffness (LS) will be measured on a cylinder of hepatic tissue of 1 cm of diameter and 4 cm of length. For assessing the splenic stiffness (SS), the patient will be in supine position with left arm in maximum abduction. Ultrasonography will be used to identify and locate the spleen parenchyma, to choose the right place for SS measurement, and to measure the spleen diameter (long axis). A median value of 10 successful acquisitions, expressed in kPa, will be kept as a representative of the LS and SS measurements. The LS and SS measurement failure will be recorded when no value will be obtained after at least 10 shots. The results will be considered unreliable in the following circumstances: valid shots fewer than 10, success rate < 60%, or interquartile range / LS >30 %. Liver and splenic stiffness, LSPS score (LS measurement × spleen diameter / platelet count), Platelet count to spleen diameter ratio (PSR) will be calculated. Patient will also undergo upper gastrointestinal endoscopy. HVPG will be done if indicated.
  • Statistical Analysis: Data will be entered into Microsoft Excel and will be analyzed using SPSS version 22. Stastical test applied will be student t test or Mann Whitney test to compare continuous data among patients with and without high-risk esophageal varices. Categorical data will be analyzed using Chi square test or Fisher Exact test whichever applicable. Univariate and multivariate logistic regression will be applied for finding the predictor of esophageal varices needing treatment. Composite score model will be formed using liver stiffness, splenic stiffness and radiological / laboratory tests to predict esophageal varices needing treatment keeping negative predictive value at least 0.95. Diagnostic test will be applied to find the cutoff value for liver stiffness and splenic stiffness by using AUROC. The correlation of liver and splenic stiffness with HVPG will be studied with Pearson's correlation coefficient.
  • Adverse effects: No
  • Stopping rule of study: No

Expected outcome of the project:

  1. Utility of liver and splenic stiffness will be assessed to form a composite score to predict presence of esophageal varices needing treatment in patients of NASH related cACLD.
  2. Correlation of the liver and splenic stiffness with HVPG in patients of NASH related cACLD will be assessed.
  3. Utility of various noninvasive tests will be assessed in predicting presence of esophageal varices needing treatment in patients of HBV or HCV related cACLD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • India
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110070
        • Institute of Liver & Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients of MASLD related cACLD (Liver Stiffness ≥10 kPa).

Description

Inclusion Criteria:

  • MASLD will be diagnosed by liver biopsy or ultrasound steatosis / Fibroscan CAP > 250 dB + any 1 criteria of metabolic syndrome:

    1. Waist circumference 90 ≥ cm for males or ≥80 cm for females
    2. Triglycerides ≥150 mg/dL
    3. HDL-C < 40 mg/dL in males or < 50 mg/dl in females
    4. systolic blood pressure (SBP) ≥130 mm Hg or diastolic blood pressure (DBP) ≥ 85 mmHg or both and
    5. 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:

  1. Age < 18 and > 70 years, Other etiologies of liver disease.
  2. Past or present history of decompensation (ascites, variceal bleed, hepatic encephalopathy, jaundice),
  3. Child Pugh B or C,
  4. unreliable liver and splenic stiffness in Fibroscan examination,
  5. Transjugular intrahepatic portosystemic shunt, significant alcohol intake (> 30 gm/day (M) and 20gm/day (F),
  6. Acute on chronic liver failure,
  7. AST and/or ALT > 5 times the upper limit of normal.
  8. Hepatocellular carcinoma or any space-occupying lesion in the liver,
  9. Portal vein thrombosis,
  10. Biliary obstruction,
  11. HVOTO,
  12. Cardiac failure,
  13. Prior variceal endotherapy or ongoing beta blocker treatment.
  14. HIV,
  15. Any malignancy,
  16. Pregnancy,
  17. ICD / pacemaker,
  18. No consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
MASLD related cACLD
MASLD related cACLD (Liver Stiffness ≥10 kPa).
Other: No intervention
This is an observational study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Utility of BAVENO 7 criteria to predict presence of esophageal varices needing treatment in patients of MASLD related cACLD.
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Correlation of LSM and SSM with grade of EV
Time Frame: Day 0
Day 0
Utility of other NITs in predicting VNT in MASLD related cACLD
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Liver and Biliary Sciences, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ILBS-Cirrhosis-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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