Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy: An Open Label Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Regenerated liver volume on Post-operative Day 14 between two groups.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Negative consent
- •Hypersensitivity to UDCA
- •Past history of UDCA use in the last two weeks
研究组 & 干预措施
Study Arm
This group will recieve Tab Ursodeoxycholic acid 450mg twice daily from the day after donor hepatectomy till post operative day 10.
干预措施: Ursodeoxycholic acid (Drug)
Control Arm
This group will receive standard medical therapy following donor hepatectomy.
干预措施: Standard Medical Treatment (Other)
结局指标
主要结局
Regenerated liver volume on Post-operative Day 14 between two groups.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Total bilirubin(Post-operative day 1-7, 10 and 14)
- Direct bilirubin(Post-operative day 1-7, 10 and 14)
- Alanine Aminotransferase(ALT)(Post-operative day 1-7, 10 and 14)
- Aspartate Aminotransferase(AST)(Post-operative day 1-7, 10 and 14)
- Serum Alkaline Phosphatase(SAP)(Post-operative day 1-7, 10 and 14)
- Serum Gamma Glutamyl Transferase(GGT)(Post-operative day 1-7, 10 and 14)
- Serum Albumin(Post-operative day 1-7, 10 and 14)
- International normalized ratio(INR)(Post-operative day 1-7, 10 and 14)
- Post hepatectomy liver failure(PHLF)(Post operative day 1-14)
- Abdominal Drain removal(Post operative day 1-14)
- Post-operative ascites(Post operative day 1-14)
- Post-operative complications(Post operative day 1-14)
- Markers of liver regeneration - Serum TNF Alpha(Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day7)
- Markers of liver regeneration - Serum IL6(Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7)
- Markers of liver regeneration - Serum Alpha Fetoprotein(Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7)
- Markers of liver regeneration - TGF Beta(Pre-op Baseline, Post-operative Day 1, Post-operative Day 3, Post-operative Day 7)
- Markers of liver regeneration - Hepatocyte growth factor in blood(Pre-op Baseline , Post-operative Day 1, Post-operative Day 3, Post-operative Day 7)