Utility of Liver and Splenic Stiffness in Predicting Esophageal Varices in Patients With Acute on Chronic Liver Failure

Acute-On-Chronic Liver Failure Clinical Trial

Official title:

Utility of Liver and Splenic Stiffness in Predicting Esophageal Varices in Patients With Acute on Chronic Liver Failure- A Cross-Sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983108
• Other study ID #: ILBS-ACLF-07
• Status: Completed
• Start date: September 18, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2023
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Monitoring and Assessment: Transient Elastography will be performed in morning hours using the FibroScan apparatus (Echosens), which consists of a 5-MHz ultrasound transducer probe mounted on the axis of a vibrator. The tip of the transducer (M-or XL probe) will be covered with a drop of gel and placed perpendicularly in the intercostal space, with the patient lying in dorsal decubitus position with the right arm in the maximal abduction. Under control, in time motion and in A-mode, the operator will choose a liver portion within the right liver lobe, at least 6-cm thick and free of large vascular structures, and the gallbladder. Liver stiffness (LS) will be measured on a cylinder of hepatic tissue of 1 cm of diameter and 4 cm of length. For assessing the splenic stiffness (SS), the patient will be in supine position with left arm in maximum abduction. Ultrasonography will be used to identify and locate the spleen parenchyma, to choose the right place for SS measurement, and to measure the spleen diameter (long axis). Transducer will be placed in the left intercostal spaces, with location indicated by the ultrasound. A median value of 10 successful acquisitions, expressed in kPa, will be kept as a representative of the LS and SS measurements. The LS and SS measurement failure will be recorded when no value will be obtained after at least 10 shots. The results will be considered unreliable in the following circumstances: valid shots fewer than 10, success rate < 60%, or interquartile range / LS >30 %. Liver and splenic stiffness, LSPS score (LS measurement × spleen diameter / platelet count), Platelet count to spleen diameter ratio (PSR) will be calculated. Patient will also undergo upper g.i. endoscopy on same day. HVPG and TJLB will be done if indicated. The study will assess whether the stiffness scores correlate with presence of esophageal varices. Optimum cutoffs will be calculated for predicting the presence of esophageal varices.

• Study design: A Cross-Sectional Study

• Study period: 12 months

• Sample size with justification: Consecutive Patients of ACLF from approval of study to 12 months. ACLF patients will be screened and eligible patients will be taken in to the study.

• Intervention: Patients of ACLF will undergo upper g.i. endoscopy, liver and splenic stiffness measurement. HVPG and TJLB will be done in the patients only if clinically indicated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients of ACLF (APASL criteria).

Exclusion Criteria:

1. Age < 18 and > 70 years

2. moderate to severe ascites

3. Portal Vein Thrombosis

4. Hepatocellular carcinoma

5. space occupying lesion liver

6. heart failure

7. biliary obstruction

8. prior variceal endotherapy or ongoing beta blocker treatment for varices

9. pregnancy

10. ICD / pacemaker

11. ongoing treatment for HBV

12. HCV or ended within 3 months

13. No consent.

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Esophageal and Gastric Varices
• Hepatic Insufficiency
• Liver Failure

Intervention

Other:
• No Intervention
No intervention. This is an observational Study

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the utility of liver and splenic stiffness and develop a model to predict presence of esophageal varices needing treatment in patients of ACLF.	Utility will be find out from the cut off values of ROC with maximum sensitivity.	Day 1
Secondary	To study the correlation of liver and splenic stiffness with grade of esophageal varices.		Day 1
Secondary	To study utility of liver and splenic stiffness in evaluating esophageal varices in comparison with other non-invasive tests.		Day 1
Secondary	To study correlation of liver and splenic stiffness with HVPG in patients of ACLF.		Day 1