Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ursodeoxycholic acid, Standard Medical Treatment.
- Who it may be relevant to
- Registry conditions: Chronic Liver Disease. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients : A Placebo Controlled Randomised Trial
Overview
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
- Drug Ursodeoxycholic acid
Tab Ursodeoxycholic acid 15mg/kg in two divided doses - Other Standard Medical Treatment
Standard Medical Treatment
Primary outcome measures
- 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) [Time frame: Post-Operative Day 14]
Secondary outcome measures (8)
- 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. [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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
India · 1 center
- ILBS — New Delhi
Identifiers
NCT: NCT07664020 · IEC/2026/126/MA01