Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy
- Conditions
- Partial Liver ResectionLiver RegenerationUrsodeoxycholic Acid
- Interventions
- Other: Standard Medical Treatment
- Registration Number
- NCT06091787
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- Negative consent
- Hypersensitivity to UDCA
- Past history of UDCA use in the last two weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm Standard Medical Treatment This group will receive standard medical therapy following donor hepatectomy. Study Arm Ursodeoxycholic acid This group will recieve Tab Ursodeoxycholic acid 450mg twice daily from the day after donor hepatectomy till post operative day 10.
- Primary Outcome Measures
Name Time Method 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
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)
- Secondary Outcome Measures
Name Time Method Direct bilirubin Post-operative day 1-7, 10 and 14 serum Direct bilirubin versus control group
Aspartate Aminotransferase(AST) Post-operative day 1-7, 10 and 14 serum AST versus control group
Serum Albumin Post-operative day 1-7, 10 and 14 serum Albumin versus control group
Serum Alkaline Phosphatase(SAP) Post-operative day 1-7, 10 and 14 serum SAP versus control group
Total bilirubin Post-operative day 1-7, 10 and 14 serum total bilirubin 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
Alanine Aminotransferase(ALT) Post-operative day 1-7, 10 and 14 serum ALT versus control group
Serum Gamma Glutamyl Transferase(GGT) Post-operative day 1-7, 10 and 14 serum SAP versus control group
Post-operative complications Post operative day 1-14 Grade of post-operative complications as per Clavien-Dindo classification
Post-operative ascites Post operative day 1-14 Volume of ascites
Trial Locations
- Locations (1)
Institute of Liver and Biliary Sciences
🇮🇳New Delhi, India