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

Liver Regeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06091787
• Other study ID #: IEC/2023/104/MA01
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: September 2023
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Binoy Abraham
• Phone: 9994494055
• Email: docbinoy88[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Regeneration
• Ursodeoxycholic Acid

Intervention

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

Other:
• Standard Medical Treatment
Standard Medical Treatment

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Liver Regeneration index POD 7	Ratio of regenerated liver volume to remnant liver volume(pre-operative) on Post operative day 7	7 days after operation
Primary	Liver Regeneration index POD 14	Ratio of regenerated liver volume to remnant liver volume(pre-operative) on Post operative day 14	14 days after operation
Secondary	Total bilirubin	serum total bilirubin versus control group	Post-operative day 1-7, 10 and 14
Secondary	Direct bilirubin	serum Direct bilirubin versus control group	Post-operative day 1-7, 10 and 14
Secondary	Alanine Aminotransferase(ALT)	serum ALT versus control group	Post-operative day 1-7, 10 and 14
Secondary	Aspartate Aminotransferase(AST)	serum AST versus control group	Post-operative day 1-7, 10 and 14
Secondary	Serum Alkaline Phosphatase(SAP)	serum SAP versus control group	Post-operative day 1-7, 10 and 14
Secondary	Serum Gamma Glutamyl Transferase(GGT)	serum SAP versus control group	Post-operative day 1-7, 10 and 14
Secondary	Serum Albumin	serum Albumin versus control group	Post-operative day 1-7, 10 and 14
Secondary	International normalized ratio(INR)	INR versus control group	Post-operative day 1-7, 10 and 14
Secondary	Post hepatectomy liver failure(PHLF)	Grade of PHLF as per ISGLS criteria and 50/50 criteria	Post operative day 1-14
Secondary	Abdominal Drain removal	Day of abdominal drain removal	Post operative day 1-14
Secondary	Post-operative ascites	Volume of ascites	Post operative day 1-14
Secondary	Post-operative complications	Grade of post-operative complications as per Clavien-Dindo classification	Post operative day 1-14