An interventional study of Ursodeoxycholic acid and Standard Medical Treatment in Liver Regeneration, Ursodeoxycholic Acid and Partial Liver Resection, sponsored by Institute of Liver and Biliary Sciences, India. Completed at 1 site in India. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
The goal of this open label randomized trial is to understand the role of oral ursodeoxycholic acid(UDCA) supplementation in the liver regeneration (in terms of liver function and anatomical growth) following right lobe donor hepatectomy. The main question it aims to answer are:
This open label randomized control study aims to analyze the effect of ursodeoxycholic acid supplementation on liver regeneration following a right donor hepatectomy. All eligible live donors who undergo right donor hepatectomy during the study period will be included in the study and randomized into two groups. One group will receive Tab. UDCA 450mg twice daily for 10 days and the other group will not receive Tab UDCA. Live donors who are not willing to participate in the study, have hypersensitivity to UDCA or have used Tab UDCA in the past 2 weeks, will be excluded from the study. All live donors will be screened in the pre-operative period in the outpatient department.
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 donor hepatectomy till Non contrast CT Abdomen is done and regenerated liver volumes are analyzed. The anatomic(volumetric), functional(liver function tests) and regenerative biomarkers( HGF, TNF-Alpha, IL6, AFP, TGF-Beta) will be compared between the two groups.
Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will recieve Tab Ursodeoxycholic acid 450mg twice daily from the day after donor hepatectomy till post operative day 10.
Drug: Ursodeoxycholic acid
This group will receive standard medical therapy following donor hepatectomy.
Other: Standard Medical Treatment
Tablet Ursodeoxycholic acid 450mg per orally twice daily from Post operative day 1 to post operative day 10.
Standard Medical Treatment
Regenerated liver volume on Post-operative Day 14 between two groups.
* This will be measured by a non contrast CT Abdomen and the size of the regenerated liver after hepatectomy will be measured in millilitres * This value will be measured in both groups to identify a difference in the intervention group (getting UDCA) versus the control group ( standard medical therapy)
Time frame: 14 days after operation
Regenerated liver volume on Post-operative Day 7 between two groups.
* This will be measured by a non contrast CT Abdomen and the size of the regenerated liver after hepatectomy will be measured in millilitres * This value will be measured in both groups to identify a difference in the intervention group (getting UDCA) versus the control group ( standard medical therapy)
Time frame: 7 days after operation
Percentage of Total Liver Volume Restored on Post-operative Day 7 between two groups.
The percentage of Total liver volume restored on Post operative day 7 compared to the pre-operative total liver volume, between two groups.
Time frame: 7 days after operation
Percentage of Liver Volume restored on Post-operative Day 14 between two groups.
Percentage of liver volume restored on on Post operative day 14, compared to pre-operative total liver volume, between two groups.
Time frame: 14 days after the operation
Absolute Liver Volume growth on Day 7
Pre-operative remnant liver volume subtracted from regenerated liver volume on Post-operative day 7, between both groups.
Time frame: 7 days after the operation
Absolute Liver volume growth on day 14
Pre-operative remnant liver volume subtracted from regenerated liver volume on Post-operative day 14, between both groups.
Time frame: 14 days after the operation
Regeneration Velocity on Post operative day 14, between both groups
Rate of regeneration of liver(g/day), denoted by subtracting pre-operative remnant liver volume from regenerated liver volume on post operative day 14, divided by 14.
Time frame: 14 days after the operation
Total bilirubin
serum total bilirubin versus control group
Time frame: Post-operative day 1-7, 10 and 14
Direct bilirubin
serum Direct bilirubin versus control group
Time frame: Post-operative day 1-7, 10 and 14
Alanine Aminotransferase(ALT)
serum ALT versus control group
Time frame: Post-operative day 1-7, 10 and 14
Aspartate Aminotransferase(AST)
serum AST versus control group
Time frame: Post-operative day 1-7, 10 and 14
Serum Alkaline Phosphatase(SAP)
serum SAP versus control group
Time frame: Post-operative day 1-7, 10 and 14
Serum Gamma Glutamyl Transferase(GGT)
serum SAP versus control group
Time frame: Post-operative day 1-7, 10 and 14
Serum Albumin
serum Albumin versus control group
Time frame: Post-operative day 1-7, 10 and 14
International normalized ratio(INR)
INR versus control group
Time frame: Post-operative day 1-7, 10 and 14
Post hepatectomy liver failure(PHLF)
Grade of PHLF as per ISGLS criteria and 50/50 criteria
Time frame: Post operative day 1-14
Abdominal Drain removal
Day of abdominal drain removal
Time frame: Post operative day 1-14
Post-operative ascites
Volume of ascites
Time frame: Post operative day 1-14
Post-operative complications
Grade of post-operative complications as per Clavien-Dindo classification
Time frame: Post operative day 1-14
Markers of liver regeneration - Serum TNF Alpha
Serum TNF Alpha vs in Control group
Time frame: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day7
Markers of liver regeneration - Serum IL6
Serum IL6 vs in Control group
Time frame: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
Markers of liver regeneration - Serum Alpha Fetoprotein
Serum Alpha Fetoprotein vs in Control group
Time frame: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
Markers of liver regeneration - TGF Beta
TGF Beta vs in Control group
Time frame: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
Markers of liver regeneration - Hepatocyte growth factor in blood
Hepatocyte growth factor vs in Control group
Time frame: Pre-op Baseline , Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
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Institute of Liver and Biliary Sciences, India