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

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04983108
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Anticipated Duration (Months): 9.4
• Patients Per Site Per Month: 13.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute-On-Chronic Liver Failure	Other: No Intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 125 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Utility of Liver and Splenic Stiffness in Predicting Esophageal Varices in Patients With Acute on Chronic Liver Failure- A Cross-Sectional Study
• Actual Study Start Date: Sep 18, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Outcome Measures

Primary Outcome Measures

1. To assess the utility of liver and splenic stiffness to predict presence of esophageal varices in patients of ACLF. [Day 1]

   Utility will be find out from the cut off values of ROC with maximum sensitivity.

Secondary Outcome Measures

1. To study the correlation of liver and splenic stiffness with grade of Esophageal varices. [Day 1]

2. To study utility of liver and splenic stiffness in evaluating Esophageal varices in comparison with other non-invasive tests. [Day 1]

3. Develop a model utilizing non-invasive tests for prediction of EV in ACLF. [Day 1]

4. To study correlation of liver and splenic stiffness with HVPG in patients of ACLF. [Day 1]

5. Ultrasound parameters predicting failure of splenic stiffness in patients of ACLF. [Day 1]

   Ultrasound parameters such as spleen size, degree of ascites would be assessed for failure of splenic stiffness.

6. Clinical parameters predicting failure of splenic stiffness in patients of ACLF. [Day 1]

   Clinical parameters such as BMI would be assessed for failure of splenic stiffness.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver & Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

• Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT04983108
• Other Study ID Numbers: ILBS-ACLF-07
• First Posted: Jul 30, 2021
• Last Update Posted: Sep 21, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure; Esophageal and Gastric Varices

Study Results

No Results Posted as of Sep 21, 2021