The Effects of Dexamethasone Administration on Jaundice Following Liver Resection: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- period in days from the day serum total bilirubin (TB) >=2.5 ULN to the day TB decreased to 1.5 ULN
研究概览
简要总结
The investigators were aiming to evaluate whether dexamethasone administration accelerates the recovery from hepatectomy-related jaundice and decreases the rates of post-hepatectomy liver failure and its safety in the subjects who developed elevated serum total bilirubin.
详细描述
Post-operative jaundice is one of the most common complications after hepatectomy for various liver tumors. Glucocorticoids, including dexamethasone, prednisolone, and methylprednisolone, were widely used to treat jaundice in the patients with severe hepatitis, liver dysfunction or liver failure. It was reported that glucocorticoids decrease the rates of liver dysfunction or mortality in those patients. However, whether post-operative glucocorticoids administration alleviated jaundice or deceased the rates of post-hepatectomy liver failure (PLF) yet to be determined. In this study, the investigators were aiming to evaluate whether dexamethasone administration accelerates the recovery from hepatectomy-related jaundice and decreases the rates of PLF and its safety in the subjects who developed elevated serum TB.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients underwent open hepatectomy for liver tumors
- •Preoperative liver function was Child-Pugh A, and the liver shear wave elastography (SWE) < 30 kPa
- •Postoperative serum total bilirubin > 2.5 ULN in 7 days after hepatectomy
排除标准
- •Patients with hilar cholangiocarcinoma or other disease with obstructive jaundice
- •Complicating disease with severe dysfunction in respiratory or circulation system or kidney.
- •Patients with contraindication of glucocorticoids, including severe infection, active GI bleeding
研究组 & 干预措施
Dexamethasone
Dexamethasone 10 mg iv on day 1 and day 2, then 5 mg iv on day 3. For the patients the serum total bilirubin did not decrease to 1.5 ULN, then 5 mg iv on day 4.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
period in days from the day serum total bilirubin (TB) >=2.5 ULN to the day TB decreased to 1.5 ULN
时间窗: up to 30 days after hepatectomy
次要结局
- The dynamic change of serum total bilirubin(up to 30 days after hepatectomy)
- length of hospital stay(up to 30 days after surgery)
- inhospital expenses(up to 30 days after surgery)
- post-operative complications, including postoperative liver failure, infection and GI bleeding(up to 30 days after surgery)
- The dynamic change of serum glutamine aminotransferase(up to 30 days after surgery)
研究者
Hui-Chuan Sun
Deputy Director of the Department of Liver Surgery
Shanghai Zhongshan Hospital