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

  • STATUS
    Recruiting
  • days left to enroll
    39
  • participants needed
    125
  • sponsor
    Institute of Liver and Biliary Sciences, India
Updated on 30 September 2021

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.

Details
Condition Acute on Chronic Liver Failure
Treatment No intervention
Clinical Study IdentifierNCT04983108
SponsorInstitute of Liver and Biliary Sciences, India
Last Modified on30 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients of ACLF (APASL criteria)

Exclusion Criteria

Age < 18 and > 70 years
moderate to severe ascites
Portal Vein Thrombosis
Hepatocellular carcinoma
space occupying lesion liver
heart failure
biliary obstruction
prior variceal endotherapy or ongoing beta blocker treatment for varices
pregnancy
ICD / pacemaker
ongoing treatment for HBV
HCV or ended within 3 months
No consent
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