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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
130
Tab Ursodeoxycholic acid 15mg/kg in two divided doses
Standard Medical Treatment
ILBS
New Delhi, National Capital Territory of Delhi, India
Regenerated liver volume
Time frame: 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)
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)
Time frame: Post-Operative Day 14
Change in Liver Function test
Time frame: Post-Operative Day 1 to Day 7, Day 10 and Day 14
Change in Coagulation parameter
Time frame: Post-Operative Day 1 to Day 7, Day 10 and Day 14
Change in Serum levels of biomarkers.
Time frame: Post-Operative Day 0, 2, 5 and 7
Daily ascitic fluid output in drain/24hr
Time frame: Daily till Post-Operative Day 14
Total ascitic fluid output till POD-14
Time frame: Post-Operative Day 14
Bile acid receptors expression for UDCA.
{FXR receptor concentration (hepatocytes), TGR-5 receptor concentration (cholangiocytes) of the explant liver}
Time frame: Post-Operative Day 1
Evaluation of monocyte number and function (flowcytometry)
Time frame: Post-Operative Day 1
Mitochondrial and nuclear DNA (markers of Ischemia-reperfusion injury)- flowcytometry
Time frame: Post-Operative Day 14
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