Chronic Liver DiseaseNCT05044663
Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in MASLD Related Compensated Advanced Chronic Liver Disease.
An observational study of Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Liver Disease
- How many people
- 325 participants
- Where
- 1 siteIndia
- Study dates
- 18 Sep 2021to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients of MASLD related cACLD (Liver Stiffness ≥10 kPa).
Who may be able to join
- MASLD will be diagnosed by liver biopsy or ultrasound steatosis / Fibroscan CAP > 250 dB + any 1 criteria of metabolic syndrome:
- 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.
Who cannot join
- Age < 18 and > 70 years, Other etiologies of liver disease.
- Past or present history of decompensation (ascites, variceal bleed, hepatic encephalopathy, jaundice),
- Child Pugh B or C,
- unreliable liver and splenic stiffness in Fibroscan examination,
- Transjugular intrahepatic portosystemic shunt, significant alcohol intake (> 30 gm/day (M) and 20gm/day (F),
- Acute on chronic liver failure,
Show all 18Show fewer
- AST and/or ALT > 5 times the upper limit of normal.
- Hepatocellular carcinoma or any space-occupying lesion in the liver,
- Portal vein thrombosis,
- Biliary obstruction,
- HVOTO,
- Cardiac failure,
- Prior variceal endotherapy or ongoing beta blocker treatment.
- HIV,
- Any malignancy,
- Pregnancy,
- ICD / pacemaker,
- No consent.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: 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.
- Conditions
- Chronic Liver Disease
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| MASLD related cACLD | MASLD related cACLD (Liver Stiffness ≥10 kPa). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of BAVENO 7 criteria to predict presence of esophageal varices needing treatment in patients of MASLD related cACLD.
Measured: Day 0
Secondary outcomes (2)
Utility of other NITs in predicting VNT in MASLD related cACLD
Measured: Day 0
Correlation of LSM and SSM with grade of EV
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start18 Sep 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044663
- Sponsor's protocol ID
- ILBS-Cirrhosis-43
- Status last verified
- Apr 2023
- First submitted
- 27 Aug 2021
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vashishtha C, Bhardwaj A, Thapar Laroia S, Prasad M, Jindal A, Sharma MK, Sarin SK. Baveno VII Algorithm can be Used to Exclude Varices Needing Treatment in MASLD Related Compensated Advanced Chronic Liver DiseasePatients. J Clin Exp Hepatol. 2026 Sep-Oct;16(5):103596. doi: 10.1016/j.jceh.2026.103596. Epub 2026 Jul 13.
PubMed 42519553
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in MASLD Related Compensated Advanced Chronic Liver Disease - A Cross-Sectional Study.
- ClinicalTrials.gov ID
- NCT05044663
- Acronym / sponsor ID
- ILBS-Cirrhosis-43
- Conditions
- Chronic Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 18 Sep 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MASLD related cACLD | – | Other: No interventionMASLD related cACLD (Liver Stiffness ≥10 kPa). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients of MASLD related cACLD (Liver Stiffness ≥10 kPa).
Key inclusion criteria (6 listed)
- MASLD will be diagnosed by liver biopsy or ultrasound steatosis / Fibroscan CAP > 250 dB + any 1 criteria of metabolic syndrome:
Key exclusion criteria (18 listed)
- Age < 18 and > 70 years, Other etiologies of liver disease.
- Past or present history of decompensation (ascites, variceal bleed, hepatic encephalopathy, jaundice),
- Child Pugh B or C,
- unreliable liver and splenic stiffness in Fibroscan examination,
- Transjugular intrahepatic portosystemic shunt, significant alcohol intake (> 30 gm/day (M) and 20gm/day (F),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study | Other | MASLD related cACLD |
Primary outcome
Utility of BAVENO 7 criteria to predict presence of esophageal varices needing treatment in patients of MASLD related cACLD.
Time frame: Day 0
2 secondary outcomes
Utility of other NITs in predicting VNT in MASLD related cACLD
Time frame: Day 0
Correlation of LSM and SSM with grade of EV
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Derived from this study: PubMed 42519553Vashishtha C, Bhardwaj A, Thapar Laroia S, Prasad M, Jindal A, Sharma MK, Sarin SK. Baveno VII Algorithm can be Used to Exclude Varices Needing Treatment in MASLD Related Compensated Advanced Chronic Liver DiseasePatients. J Clin Exp Hepatol. 2026 Sep-Oct;16(5):103596. doi: 10.1016/j.jceh.2026.103596. Epub 2026 Jul 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility of BAVENO 7 criteria to predict presence of esophageal varices needing treatment in patients of MASLD related cACLD. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05044663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.