se of non invasive methods in Liver Dieseae for predicting bleed

Not Applicable

• Conditions: Health Condition 1: K746- Other and unspecified cirrhosis ofliver

• Registration Number: CTRI/2022/01/039146
• Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Clinical / radiological /histologic diagnosis of cirrhosis (Child A&B)

2) Age >18 years

3) Advanced compensated liver disease of different etiology(Viral,metabolic,alcoholic)

Upper GI bleed

4) Valid consent

5) No history of NSBB use in last 6 weeks

Exclusion Criteria

1) Age > 70 years

2) Portal vein thrombosis

3) Underlaying shunts

4) Spleen anteroposterior diameter <4cm

5) Non cirrhotic portal hypertension

6) Only PHG, Ectopic varices

7) Heart rate <50bpm, SBP <100mm of Hg,Asthma, COPD, Aortic disease, atrioventricular block, Peripheral vascular disease.

8) Pregnancy

9) obese(BMI >30mm of Hg)

10) HIV

11) HCC / Other malignancy

12) Other Comorbidities: Chronic kidney disease [ CrCl < 30] 13) Cirrhosis : Child C Stroke Cardiac failure, Uncontrolled diabetes(HbA1c >9)

13) AST/ALT >5 times

14) Drug allergies

15) ACLF

16) Narrow intercoastal space

17) Failure to give informed consent from family members.

18) Patient enrolled in other clinical study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HVPG and its correlation with non-invasive methods.Timepoint: 6 weeks

Secondary Outcome Measures

Name	Time	Method
AAR, APRI, FIB 4 index, CSPH risk score,fibrosis index, GPR, King score, Lok score are other non invasive testsTimepoint: 6 weeks;Assessment of severity of portal hypertension by non-invasive methodsTimepoint: 6 weeks;Comparison of hypersplenism (Splenic volume and area) and hematological parameters before and after treatmentTimepoint: 6 weeks;Correlation and Cut-off values for non-invasive methods in responders and non-responders in relation to HVPGTimepoint: 6 weeks;Diagnosis and response assessment by convolutional neural network- AI based modelTimepoint: 6 weeks;Prognostic implication of HVPG rebleed on EVL with beta-blockersTimepoint: 6 weeks