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

NCT06091787 | Completed

• 1 other identifier: IEC/2023/104/MA01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Regeneration; Ursodeoxycholic Acid; Partial Liver Resection

Outcome Measures

Primary Outcomes (7)

• 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)

  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)

  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.

  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.

  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.

  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.

  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.

  14 days after the operation

Secondary Outcomes (17)

• Total bilirubin

  Post-operative day 1-7, 10 and 14

• Direct bilirubin

  Post-operative day 1-7, 10 and 14

• Alanine Aminotransferase(ALT)

  Post-operative day 1-7, 10 and 14

• Aspartate Aminotransferase(AST)

  Post-operative day 1-7, 10 and 14

• Serum Alkaline Phosphatase(SAP)

  Post-operative day 1-7, 10 and 14

Study Arms (2)

Study Arm

EXPERIMENTAL

This group will recieve Tab Ursodeoxycholic acid 450mg twice daily from the day after donor hepatectomy till post operative day 10.

Drug: Ursodeoxycholic acid

Control Arm

ACTIVE COMPARATOR

This group will receive standard medical therapy following donor hepatectomy.

Other: Standard Medical Treatment

Interventions

Ursodeoxycholic acid DRUG

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

Study Arm

Standard Medical Treatment OTHER

Standard Medical Treatment

Control Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, 110070, India

Location

MeSH Terms

Interventions

Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Nihar Rn Mohapatra, MBBS,MS, MCh

  Institute of Liver and Biliary Sciences, New Delhi

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label randomised controlled trial with 2 groups. One group receiving Tablet Ursodeoxycholic acid and the other group not receiving standard medical therapy

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 19, 2023
• Study Start: September 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)