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

NCT04983108 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 216

Last updated 2025-01-22

No results posted yet for this study

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.

Conditions

  • Acute-On-Chronic Liver Failure

Interventions

OTHER

No Intervention

No intervention. 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
2021-09-18
Primary Completion
2022-09-30
Completion
2022-09-30

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 NCT04983108 on ClinicalTrials.gov