Chronic Liver Disease
Conditions
Brief 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.
Interventions
DRUGUrsodeoxycholic acid
Tab Ursodeoxycholic acid 15mg/kg in two divided doses
OTHERStandard Medical Treatment
Standard Medical Treatment
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
All Adult Living Donor Liver Transplant (LDLT) Recipients in ILBS from ethical board clearance to December 2027 in the Department of HPB Surgery and Liver Transplantation, Institute of Liver and Biliary Sciences
Exclusion criteria
* Unwillingness to participate * Hypersensitivity to UDCA * Patients receiving UDCA pre-operatively within 1 month of liver transplant (PBC and patients of overlap syndrome) * Right posterior and left laterals grafts * Emergency Liver Transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liver Function test | Post-Operative Day 1 to Day 7, Day 10 and Day 14 | — |
| Change in Coagulation parameter | Post-Operative Day 1 to Day 7, Day 10 and Day 14 | — |
| Change in Serum levels of biomarkers. | Post-Operative Day 0, 2, 5 and 7 | — |
| Daily ascitic fluid output in drain/24hr | Daily till Post-Operative Day 14 | — |
| Total ascitic fluid output till POD-14 | Post-Operative Day 14 | — |
| Bile acid receptors expression for UDCA. | Post-Operative Day 1 | {FXR receptor concentration (hepatocytes), TGR-5 receptor concentration (cholangiocytes) of the explant liver} |
| Evaluation of monocyte number and function (flowcytometry) | Post-Operative Day 1 | — |
| Mitochondrial and nuclear DNA (markers of Ischemia-reperfusion injury)- flowcytometry | Post-Operative Day 14 | — |
Countries
India
Contacts
CONTACTRajguru Siwach, MS
CONTACTDr Nihar Mohapatra, MCh
Outcome results
None listed