Liver Regeneration, Partial Liver Resection, Ursodeoxycholic Acid
Conditions
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.
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.
Interventions
DRUGUrsodeoxycholic acid
Tablet Ursodeoxycholic acid 450mg per orally twice daily from Post operative day 1 to post operative day 10.
OTHERStandard Medical Treatment
Standard Medical Treatment
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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 therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| Percentage of Total Liver Volume Restored on Post-operative Day 7 between two groups. | 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. |
| Percentage of Liver Volume restored on Post-operative Day 14 between two groups. | 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. |
| Absolute Liver Volume growth on Day 7 | 7 days after the operation | Pre-operative remnant liver volume subtracted from regenerated liver volume on Post-operative day 7, between both groups. |
| Absolute Liver volume growth on day 14 | 14 days after the operation | Pre-operative remnant liver volume subtracted from regenerated liver volume on Post-operative day 14, between both groups. |
| Regeneration Velocity on Post operative day 14, between both groups | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Total bilirubin | Post-operative day 1-7, 10 and 14 | serum total bilirubin versus control group |
| Markers of liver regeneration - Serum IL6 | Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7 | Serum IL6 vs in Control group |
| Markers of liver regeneration - Serum Alpha Fetoprotein | Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7 | Serum Alpha Fetoprotein vs in Control group |
| Markers of liver regeneration - TGF Beta | Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7 | TGF Beta vs in Control group |
| Markers of liver regeneration - Hepatocyte growth factor in blood | Pre-op Baseline , Post-operative Day 1, Post-operative Day 3, Post-operative Day 7 | Hepatocyte growth factor vs in Control group |
| Markers of liver regeneration - Serum TNF Alpha | Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day7 | Serum TNF Alpha vs in 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 |
Countries
India
Outcome results
None listed