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

December 17, 2025 updated by: Institute of Liver and Biliary Sciences, India

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • New Delhi, India, 110070
        • Institute of Liver and Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Arm
This group will recieve Tab Ursodeoxycholic acid 450mg twice daily from the day after donor hepatectomy till post operative day 10.
Drug: Ursodeoxycholic acid
Tablet Ursodeoxycholic acid 450mg per orally twice daily from Post operative day 1 to post operative day 10.
Active Comparator: Control Arm
This group will receive standard medical therapy following donor hepatectomy.
Other: Standard Medical Treatment
Standard Medical Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
7 days after operation
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)
14 days after operation
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.
7 days after operation
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.
14 days after the operation
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.
7 days after the operation
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.
14 days after the operation
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.
14 days after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total bilirubin
Time Frame: Post-operative day 1-7, 10 and 14
serum total bilirubin versus control group
Post-operative day 1-7, 10 and 14
Direct bilirubin
Time Frame: Post-operative day 1-7, 10 and 14
serum Direct bilirubin versus control group
Post-operative day 1-7, 10 and 14
Alanine Aminotransferase(ALT)
Time Frame: Post-operative day 1-7, 10 and 14
serum ALT versus control group
Post-operative day 1-7, 10 and 14
Aspartate Aminotransferase(AST)
Time Frame: Post-operative day 1-7, 10 and 14
serum AST versus control group
Post-operative day 1-7, 10 and 14
Serum Alkaline Phosphatase(SAP)
Time Frame: Post-operative day 1-7, 10 and 14
serum SAP versus control group
Post-operative day 1-7, 10 and 14
Serum Gamma Glutamyl Transferase(GGT)
Time Frame: Post-operative day 1-7, 10 and 14
serum SAP versus control group
Post-operative day 1-7, 10 and 14
Serum Albumin
Time Frame: Post-operative day 1-7, 10 and 14
serum Albumin versus control group
Post-operative day 1-7, 10 and 14
International normalized ratio(INR)
Time Frame: Post-operative day 1-7, 10 and 14
INR versus control group
Post-operative day 1-7, 10 and 14
Post hepatectomy liver failure(PHLF)
Time Frame: Post operative day 1-14
Grade of PHLF as per ISGLS criteria and 50/50 criteria
Post operative day 1-14
Abdominal Drain removal
Time Frame: Post operative day 1-14
Day of abdominal drain removal
Post operative day 1-14
Post-operative ascites
Time Frame: Post operative day 1-14
Volume of ascites
Post operative day 1-14
Post-operative complications
Time Frame: Post operative day 1-14
Grade of post-operative complications as per Clavien-Dindo classification
Post operative day 1-14
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
Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day7
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
Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
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
Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
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
Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7
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
Pre-op Baseline , Post-operative Day 1, Post-operative Day 3, Post-operative Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Study Chair: Nihar Rn Mohapatra, MBBS,MS, MCh, Institute of Liver and Biliary Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC/2023/104/MA01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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