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NCT Number: NCT06091787

Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy

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:

* Does Ursodeoxycholic acid supplementation on patients undergoing donor hepatectomy improve anatomical liver regeneration after partial hepatectomy as compared to control group. * Does ursodeoxycholic acid improve liver regeneration in terms of liver function tests and biomarkers of liver regeneration(HGF, IL6, TNF Alpha, AFP, TGF Beta) as compared to control group.

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Key information

Conditions

Liver Regeneration Partial Liver Resection Ursodeoxycholic Acid

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

New Delhi, 110070, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All live donors undergoing Right Donor Hepatectomy in ILBS from ethical board clearance to December 2024 in the Department of HPB Surgery and Liver Transplantation, Institute of Liver and Biliary Sciences, New Delhi

Exclusion criteria

  • Negative consent
  • Hypersensitivity to UDCA
  • Past history of UDCA use in the last two weeks

Treatment and study plan

Ursodeoxycholic acid

Drug

Tablet Ursodeoxycholic acid 450mg per orally twice daily from Post operative day 1 to post operative day 10.

Standard Medical Treatment

Other

Standard Medical Treatment

Primary outcomes

  1. Regenerated liver volume on Post-operative Day 14 between two groups.

    Time frame: 14 days after operation

    • 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)

  2. Regenerated liver volume on Post-operative Day 7 between two groups.

    Time frame: 7 days after operation

    • 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)

  3. Percentage of Total Liver Volume Restored on Post-operative Day 7 between two groups.

    Time frame: 7 days after operation

    The percentage of Total liver volume restored on Post operative day 7 compared to the pre-operative total liver volume, between two groups.

  4. Percentage of Liver Volume restored on Post-operative Day 14 between two groups.

    Time frame: 14 days after the operation

    Percentage of liver volume restored on on Post operative day 14, compared to pre-operative total liver volume, between two groups.

  5. Absolute Liver Volume growth on Day 7

    Time frame: 7 days after the operation

    Pre-operative remnant liver volume subtracted from regenerated liver volume on Post-operative day 7, between both groups.

  6. Absolute Liver volume growth on day 14

    Time frame: 14 days after the operation

    Pre-operative remnant liver volume subtracted from regenerated liver volume on Post-operative day 14, between both groups.

  7. Regeneration Velocity on Post operative day 14, between both groups

    Time frame: 14 days after the operation

    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.

Secondary outcomes

  1. Total bilirubin

    Time frame: Post-operative day 1-7, 10 and 14

    serum total bilirubin versus control group

  2. Direct bilirubin

    Time frame: Post-operative day 1-7, 10 and 14

    serum Direct bilirubin versus control group

  3. Alanine Aminotransferase(ALT)

    Time frame: Post-operative day 1-7, 10 and 14

    serum ALT versus control group

  4. Aspartate Aminotransferase(AST)

    Time frame: Post-operative day 1-7, 10 and 14

    serum AST versus control group

  5. Serum Alkaline Phosphatase(SAP)

    Time frame: Post-operative day 1-7, 10 and 14

    serum SAP versus control group

  6. Serum Gamma Glutamyl Transferase(GGT)

    Time frame: Post-operative day 1-7, 10 and 14

    serum SAP versus control group

  7. Serum Albumin

    Time frame: Post-operative day 1-7, 10 and 14

    serum Albumin versus control group

  8. International normalized ratio(INR)

    Time frame: Post-operative day 1-7, 10 and 14

    INR versus control group

  9. Post hepatectomy liver failure(PHLF)

    Time frame: Post operative day 1-14

    Grade of PHLF as per ISGLS criteria and 50/50 criteria

  10. Abdominal Drain removal

    Time frame: Post operative day 1-14

    Day of abdominal drain removal

  11. Post-operative ascites

    Time frame: Post operative day 1-14

    Volume of ascites

  12. Post-operative complications

    Time frame: Post operative day 1-14

    Grade of post-operative complications as per Clavien-Dindo classification

  13. Markers of liver regeneration - Serum TNF Alpha

    Time frame: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day7

    Serum TNF Alpha vs in Control group

  14. Markers of liver regeneration - Serum IL6

    Time frame: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7

    Serum IL6 vs in Control group

  15. Markers of liver regeneration - Serum Alpha Fetoprotein

    Time frame: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7

    Serum Alpha Fetoprotein vs in Control group

  16. Markers of liver regeneration - TGF Beta

    Time frame: Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7

    TGF Beta vs in Control group

  17. Markers of liver regeneration - Hepatocyte growth factor in blood

    Time frame: Pre-op Baseline , Post-operative Day 1, Post-operative Day 3, Post-operative Day 7

    Hepatocyte growth factor vs in Control group

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy: An Open Label Randomised Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2023
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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