Role of Splenic stiffness measurement to predict High risk esophageal varices in cirrhosis

Not Applicable

• Conditions: Health Condition 1: K702- Alcoholic fibrosis and sclerosis of liverHealth Condition 2: K754- Autoimmune hepatitisHealth Condition 3: K721- Chronic hepatic failureHealth Condition 4: K740- Hepatic fibrosisHealth Condition 5: K746- Other and unspecified cirrhosis ofliverHealth Condition 6: K766- Portal hypertensionHealth Condition 7: K717- Toxic liver disease with fibrosisand cirrhosis of liver

• Registration Number: CTRI/2023/07/055222
• Lead Sponsor: Dr Manas Kumar Panigrahi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age > 18 years

2. Features of cirrhosis â?? based on clinical, biochemical, radiological, and transient elastography findings and liver biopsy when appropriate.

3. Willing to give informed consent for participation in the study

Exclusion Criteria

1. Grade II/III ascites at time of evaluation

2. Non-cirrhotic portal hypertension â?? Extrahepatic Portal vein obstruction (EHPVO), Non-cirrhotic portal fibrosis (NCPF)

3. History of Endoscopic variceal ligation

4. Currently using beta-blocker for prophylaxis

5. Portal vein thrombosis

6. Patients having liver space-occupying lesion on imaging

7. History of variceal hemorrhage in last 4 weeks

8. History of liver transplantation

9. History of a transjugular intrahepatic portosystemic shunt (TIPS)

10. History of splenectomy

11. Presence of heart failure

12. Pregnancy

13. Patients are not willing to give informed consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the diagnostic accuracy of splenic stiffness measurement using a novel spleen dedicated transient elastography in predicting high risk esophageal varices in patients with liver cirrhosis.Timepoint: All the parameters will be assessed at baseline after patient enrolment

Secondary Outcome Measures

Name	Time	Method
To compare the diagnostic accuracy of splenic stiffness measurement with Baveno VI consensus criteria in identifying low-risk group where screening endoscopy for variceal assessment can be avoided.Timepoint: December 2023