Effect of Pentoxifylline on Liver Regeneration After Right Lobe Donor Hepatectomy: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess effect of Pentoxifylline supplementation on Anatomical (Volume) Regeneration of liver in the Perioperative period (POD-14) in Right lobe donor Hepatectomy
研究概览
简要总结
Posthepatectomy liver failure (PHLF) remains a significant life-threatening problem after major hepatectomies. Pentoxifylline is shown to have potent vasodilating properties for peripheral blood vessels, along with the hepatic vasculature. In a Double-blinded, randomized, controlled trial (RCT) at a single tertiary care center (2006-2009) by Petrowsky, Henrik et al (Annals of Surgery, November 2010) on 101 Non-cirrhotic patients undergoing major Hepatectomy, they demonstrated beneficial effects of Pentoxifylline on regeneration of small remnant livers (RLBW ratio ≤ 1.2%). In mice model, pentoxifylline (Tian, Yinghua, et al Proceedings of the National Academy of Sciences 103.12 (2006)) is shown to confer protective effects against small-for-size syndrome in arterialized small-for-size liver transplantation. This Randomised control trial is being conducted to analyze the effect of Pentoxifylline supplementation in live donors undergoing donor hepatectomy with respect to markers of anatomical regeneration in a high volume liver transplant center in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All live donors undergoing Right Donor Hepatectomy after ethical board clearance in the Department of HPB Surgery and Liver Transplantation
排除标准
- •Negative consent Hypersensitivity to Pentoxifylline
研究组 & 干预措施
Plasmalyte
Intravenous fluid plasmalyte.
干预措施: Plasmalyte (Other)
Pentoxifylline group
Intravenous injection Pentoxifylline
干预措施: Pentoxifylline (also known as oxpentifylline) (Drug)
结局指标
主要结局
To assess effect of Pentoxifylline supplementation on Anatomical (Volume) Regeneration of liver in the Perioperative period (POD-14) in Right lobe donor Hepatectomy
时间窗: 2 weeks post-operatively
Regenerated liver volume post-surgery Day-14 and Percentage of volume restored after Post surgery day 14 as compared to pre-operatively calculated Remnaant liver volume
次要结局
- To evaluate the effect of Pentoxifylline on Serum Bilirubin- Time to Normalization(2 weeks)
- Time to normalziation of Aspartate Transaminase(Post-operative Day 14)
- Time to normalzation of Alanine transaminase(Post-operative Day 14)
- Time to Normalisation of International Normalized Ratio(Post-operative Day 14)
- Time to normalisation of Serum Alkaline phosphatase(Post-operative Day 14)
- Time to normalisation of Gamma-Glutamyl Transferase(Post-operative Day 14)
- Effect on TNF-alpha (Tumor Necrosis Factor alpha)(Post-operative Day 7)
- Effect on IL-6 (Interleukin-6)(Post-operative day 7)
- To evaluate the effect on HGF(1 week)
- To study the effect of Pentoxifylline supplementation on post-operative complications in donor right hepatectomy(Postoperative Day 14)
- Effect on TGF-beta (Transforming Growth Factor beta)(POst-operative Day 7)
- Effect on AFP (Alpha-fetoprotein)(Post-operative day 7)