Change in splenic stiffness measurement as a marker of response to beta blocker therapy
- Conditions
- Health Condition 1: K768- Other specified diseases of liver
- Registration Number
- CTRI/2023/10/058264
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Age = 18 years
2.Cirrhosis of liver of different etiologies, with evidence of high-risk esophageal varices
3.Alcohol abstinence for 3 months
4.Written informed consent
1.Age = 70 years
2.Previous or imminent variceal ligation
3.Non Cirrhotic Portal Hypertension
4.Portal vein, splenic vein thrombosis
5.Porto-systemic shunts > 10 mm
6.Patients already on beta blockers
7.Contraindications to beta blocker therapy :
a.Heart rate < 50 bpm
b.Systolic SBP < 100 mm Hg
c.Severe COPD
d.Atrioventricular block
e.Known PVD
f.Poor control of T2DM (HbA1c >9)
8.Technical difficulties for splenic stiffness measurement
9.Cardio-pulmonary disorders
10.Budd Chiari Syndrome
11.Grade 3 ascites
12.Acute Kidney Injury or Chronic Kidney Disease
13.Severely Obese patients (BMI > 40)
14.Pregnant women
15.Advanced HCC
16.Psychiatric Illness
17.Lack of informed consent
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the diagnostic accuracy of change in splenic stiffness to predict HVPG responders to beta-blockers at 4 weeksTimepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method Change in collagen markers - Procollagen 3 peptide, tissue inhibitor of matrix metalloproteinase 1, Hyaluronic acidTimepoint: 4 weeks;Change in Fib-4, Fib-5Timepoint: 4 weeks;Change in Liver stiffness measurementTimepoint: 4 weeks;Change in vWF-antigen, VITROTimepoint: 4 weeks;To develop an AI based model to predict HVPG responders to beta blockersTimepoint: 4 weeks