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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ursodeoxycholic acid

    Drug

    Tab Ursodeoxycholic acid 15mg/kg in two divided doses

  • Standard Medical Treatment

    Other intervention

    Standard Medical Treatment

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Ursodeoxycholic acid+standard medical treatmentExperimental treatment 2 interventions
Group B: Placebo+standard medical treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Regenerated liver volume

Time frame
Post-Operative Day 14
2

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

Secondary outcomes

1

Change in Liver Function test

Time frame
Post-Operative Day 1 to Day 7, Day 10 and Day 14
2

Change in Coagulation parameter

Time frame
Post-Operative Day 1 to Day 7, Day 10 and Day 14
3

Change in Serum levels of biomarkers.

Time frame
Post-Operative Day 0, 2, 5 and 7
4

Daily ascitic fluid output in drain/24hr

Time frame
Daily till Post-Operative Day 14

Other outcomes

Sponsors and contacts

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