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

NCT05166317 | Unknown

• 1 other identifier: ILBS-Bleed-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in HVPG and its correlation with non-invasive methods.

  6 Weeks

Secondary Outcomes (6)

• Assessment of severity of portal hypertension by non-invasive methods.

  6 weeks

• Correlation and Cut-off values for non-invasive methods in responders and non-responders in relation to HVPG.

  6 weeks

• Correlation of Serological and radiological non invasive tests response in comparison with HVPG.

  6 weeks

• Comparison of hypersplenism (Splenic volume and area) and hematological parameters before and after treatment.

  6 weeks

• Diagnosis and response assessment by convolutional neural network- AI based model.

  6 weeks

Study Arms (1)

Liver Cirrhosis

All the consecutive patients of cirrhosis admitted to Intensive care unit of Hepatology department of ILBS.

Other: This is an observational study

Interventions

This is an observational study OTHER

This is an observational study

Liver Cirrhosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the consecutive patients of cirrhosis admitted to Intensive care unit of Hepatology department of ILBS will be evaluated for inclusion

You may qualify if:

• Clinical / radiological /histologic diagnosis of cirrhosis (Child A\&B)
• Age \>18 years
• Advanced compensated liver disease of different etiology(Viral,metabolic,alcoholic)
• Upper GI bleed
• Valid consent
• No history of NSBB use in last 6 weeks

You may not qualify if:

• Age \> 70 years
• Portal vein thrombosis
• Underlaying shunts
• Spleen anteroposterior diameter \<4cm
• Non cirrhotic portal hypertension
• Only PHG, Ectopic varices
• Heart rate \<50bpm, SBP\<100mm of Hg,Asthma, COPD, Aortic disease, atrioventricular block, Peripheral vascular disease.
• Pregnancy
• obese(BMI\>30mm of Hg)
• HIV
• HCC / Other malignancy
• Other Comorbidities: Chronic kidney disease \[ CrCl\< 30\] Cirrhosis : Child C Stroke Cardiac failure, Uncontrolled diabetes(HbA1c \>9)
• AST/ALT \>5 times
• Drug allergies
• ACLF

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Central Study Contacts

Dr Akhil Deshmukh, MD

CONTACT

01146300000; akhildeshmukh52@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: December 21, 2021
• Study Start: January 10, 2022
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: January 14, 2022

Record last verified: 2021-10

Locations

IN (1)