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

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06091787

Collaborator

(none)

Enrollment

Location

Arms

13.5

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Regeneration Ursodeoxycholic Acid Partial Liver Resection	Drug: Ursodeoxycholic acid Other: Standard Medical Treatment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2023

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Regenerated liver volume on Post-operative Day 7 between two groups. [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)
Regenerated liver volume on Post-operative Day 14 between two groups. [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)
Liver Regeneration index POD 7 [7 days after operation]
Ratio of regenerated liver volume to remnant liver volume(pre-operative) on Post operative day 7
Liver Regeneration index POD 14 [14 days after operation]
Ratio of regenerated liver volume to remnant liver volume(pre-operative) on Post operative day 14

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and Biliary Sciences	New Delhi		India	110070

Sponsors and Collaborators

Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institute of Liver and Biliary Sciences, India

ClinicalTrials.gov Identifier:

NCT06091787

Other Study ID Numbers:

IEC/2023/104/MA01

First Posted:

Oct 19, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Ursodeoxycholic Acid

Study Results

No Results Posted as of Oct 19, 2023