Effect of Pentoxifylline on Liver Regeneration after Right Lobe Donor Hepatectomy A Randomized control Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 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 less than 1.2 percent). 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
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •All Voluntary Healthy Liver Donors undergoing Right Lobe Donor Hepatectomy.
排除标准
- •Negative consent Hypersensitivity to pentoxifylline.
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: On Post-operative Day-14
次要结局
- To evaluate the effect of Pentoxifylline on Liver function Tests- Time to Normalization(Baseline, POD- 1 to 7 and POD 14)
- To evaluate the effect of Pentoxifylline on biomarkers of liver regeneration (HGF, TNF-alpha, IL-6, TGF Beta, AFP)(Baseline, POD-3 and POD-7)
- To study the effect of Pentoxifylline supplementation on post-operative complications in donor right hepatectomy(Discharge from hospital)
