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Comparative Efficacy of Various Non-invasive Methods in Assessing Response to Beta-blockers as Secondary Prophylaxis for Acute Variceal Bleed.

NCT05166317 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2022-01-14

No results posted yet for this study

Summary

Portal hypertension (PH) is a common complication of chronic liver disease and a major cause of morbidity and mortality in cirrhotic patients. One of the most serious complications of liver cirrhosis is esophageal varices (EV) bleeding. The hepatic venous pressure gradient (HVPG) is the gold standard for detecting portal hypertension and its complications. Furthermore, HVPG is the most reliable method for assessing the efficacy of treatment with nonselective -blockers (NSBB), which is the preferred therapy in patients with EV who are at high risk of bleeding (HRV) and as a secondary prophylaxis in the prevention of rebleed. However, the HVPG is an invasive method that is not widely used and necessitates specialized skills. For these reasons, clinical research over the last decade has been focused on identifying non-invasive tests (NITs) capable of evaluating the PH degree and its changes. The most investigated non-invasive tests are liver and splenic stiffness measurement. In advanced cirrhosis, the increase in portal pressure is less dependent on intrahepatic resistance to portal flow due to fibrosis progression and more dependent on extra-hepatic factors such as hyperdynamic circulation and splanchnic vasodilation hence correlation between LSM and PH decreases for HVPG values higher than 12 mmHg.

Conditions

  • Acute Variceal Bleed

Interventions

OTHER

This is an observational study

This is an observational study

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2022-10-10
Completion
2022-10-10

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05166317 on ClinicalTrials.gov