Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients.

Condition(s) studied

Investigational drug(s) / intervention(s)

Ursodeoxycholic acid: Tab Ursodeoxycholic acid 15mg/kg in two divided doses

Standard Medical Treatment: Standard Medical Treatment

Study summary

This placebo controlled randomized control study aims to analyze the effect of UDCA supplementation on liver regeneration in Living Donor Liver Transplant (LDLT) recipients. All eligible LDLT recipients during the study period will be included in the study and randomized into two groups. One group will receive Tab UDCA starting atleast 10 days pre-operatively and continued till post-operative day 10 and the other group will receive placebo. UDCA will be given at a dose of 15mg/kg per day in two divided doses. Recipients who are not willing to participate in the study, have hypersensitivity to UDCA will be excluded from the study. Pediatrics recipients and acute liver failure recipients will also be excluded.

Pre- operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system (PACS). The enrolled subjects will be followed up till for a period of 14 days after the transplant till NCCT Abdomen is done and regenerated liver volumes are analyzed. The anatomic(volumetric), functional(liver function tests) and regenerative biomarkers (HGF, TNF-Alpha, IL6, TGF-Beta1) will be compared between the two groups. Evaluation of incidence of Early Allograft Dysfunction (EAD) as per Modified Olthoff criteria1 will be done between the two groups. FXR receptor concentration (hepatocytes) and TGR-5 receptor concentration (cholangiocytes) will be seen in the explant liver along with evaluation of monocyte number and function and mitochondrial and nuclear DNA.

Eligibility

Primary outcome measure(s)

• Regenerated liver volume — Post-Operative Day 14
• Regeneration Liver Indices • Percentage restoration of SLV (Standard liver volume) • Regeneration index (%) : (Regenerated liver volume-GW/GW)x100 • Kinetic growth rate (volume in CC/Day) — Post-Operative Day 14
  Regeneration Liver Indices is defined by- * Percentage restoration of SLV (Standard liver volume) * Regeneration index (percentages) : (Regenerated liver volume-GW/GW)x100 * Kinetic growth rate (volume in CC/Day)

Trial sites (1)

More Institute of Liver and Biliary Sciences, India trials in India

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