Utility of Liver and Splenic Stiffness in Predicting Esophageal Varices in Patients With Acute on Chronic Liver Failure
Condition: Acute-On-Chronic Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure; Esophageal and Gastric Varices
Study type: Observational

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.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): No intervention. This is an observational Study
Other intervention name(s): This is an observational Study
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients of ACLF fulfilling the APASL (Asian Pacific Association for the Study
        of the Liver) criteria undergoing HVPG and TJLB and upper gastrointestinal endoscopy for
        variceal screening.