Clinical trial

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

Name

IEC/2023/104/MA01

Description

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.

Trial arms

Trial start

2023-10-15

Estimated PCD

2024-11-30

Trial end

2024-11-30

Status

Not yet recruiting

Treatment

Ursodeoxycholic acid

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

Arms:

Study Arm

Standard Medical Treatment

Arms:

Control Arm

Size

Primary endpoint

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

7 days after operation

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

14 days after operation

Liver Regeneration index POD 7

7 days after operation

Liver Regeneration index POD 14

14 days after operation

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open label randomised controlled trial with 2 groups. One group receiving Tablet Ursodeoxycholic acid and the other group not receiving standard medical therapy', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2023-10-19

1 organization

1 product

3 indications

Organization

Institute of Liver and Biliary Sciences

Product

Indication

Indication

Indication