Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04983108
Study type Observational
Source Institute of Liver and Biliary Sciences, India
Contact
Status Completed
Phase
Start date September 18, 2021
Completion date September 30, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05985863 - Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure Phase 1/Phase 2
Not yet recruiting NCT04822922 - Safety of UC-MSC Transfusion for ACLF Patients Phase 2
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Withdrawn NCT05940610 - The Safety and Efficacy of MSC-EVs in Acute/Acute-on-Chronic Liver Failure Phase 1/Phase 2
Not yet recruiting NCT05036031 - Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study
Recruiting NCT05019352 - Cytokine Adsorption in Acute-on-chronic Liver Failure N/A
Recruiting NCT05421351 - Immune Profile, Neuronal Dysfunction, Metabolomics and Ammonia in Therapeutic Response of HE in ACLF
Completed NCT02321371 - Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy. N/A
Not yet recruiting NCT06069037 - SALT for Treatment of Patients With Early ACLF N/A
Completed NCT02965560 - Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure
Recruiting NCT03713489 - Platelet Transfusion in HBV-related acute-on Chronic Liver Failure N/A
Withdrawn NCT03629015 - Safety Study of Stemchymal® in Acute Liver Failure Phase 1
Recruiting NCT04621812 - Role of Fecal Microbiota in Predicting Graft Rejection and Sepsis Among Recipients of Living Donor Liver Transplant in First Year.
Recruiting NCT04157465 - Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients N/A
Suspended NCT03737448 - TRimetazidine for acUte on Chronic Liver Failure STudy Phase 1
Recruiting NCT06128421 - Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk N/A
Recruiting NCT05700708 - Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites
Completed NCT04238416 - Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF Phase 1
Completed NCT03456518 - Pattern of Acute on Chronic Liver Failure in Patient With HCV Related Chronic Liver Disease
Recruiting NCT03987893 - PEG3350 in ACLF With Hepatic Encephalopathy Phase 4