ILBS
New Delhi, National Capital Territory of Delhi, 110070, India
NCT Number: NCT07664020
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
New Delhi, National Capital Territory of Delhi, 110070, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Tab Ursodeoxycholic acid 15mg/kg in two divided doses
Standard Medical Treatment
Time frame: Post-Operative Day 14
Time frame: Post-Operative Day 14
Regeneration Liver Indices is defined by-
Time frame: Post-Operative Day 1 to Day 7, Day 10 and Day 14
Time frame: Post-Operative Day 1 to Day 7, Day 10 and Day 14
Time frame: Post-Operative Day 0, 2, 5 and 7
Time frame: Daily till Post-Operative Day 14
Time frame: Post-Operative Day 14
Time frame: Post-Operative Day 1
{FXR receptor concentration (hepatocytes), TGR-5 receptor concentration (cholangiocytes) of the explant liver}
Time frame: Post-Operative Day 1
Time frame: Post-Operative Day 14
Contact information is provided by the study sponsor or research team.
Dr Nihar Mohapatra, MCh
CONTACT
Rajguru Siwach, MS
CONTACT
Institute of Liver and Biliary Sciences, India
Other
Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients : A Placebo Controlled Randomised Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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