GI-072: Randomized Controlled Trial of the Use of Octreotide to Enhance Liver Recovery After Major Hepatectomy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Rates of Liver Recovery Will be Determined by Area Under the Curve (AUC) for Total Bilirubin and INR for Each Group
研究概览
简要总结
This will be a prospective, randomized, double blind trial enrolling patients who will undergo major liver resection. Patients will be randomized in a 1:1 ratio to receive either octreotide or placebo in the postoperative period. The patients will receive octreotide intravenously continuously for five days after operation. During this period the patients' health will be monitored by performing blood tests including complete metabolic profile, Complete Blood Count (CBC) with/diff., INR and PTT. The functioning of heart will also be monitored post-operatively by EKG. Up to 80 participants will be accrued over a 2 year period. Volumetric CT scans will be performed prior to hepatectomy, 1 week after hepatectomy and 3 months after hepatectomy to evaluate liver regeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have liver tumors requiring a major liver resection, defined as removing at least three anatomical segments in patients without liver disease and two segments in patients with cirrhosis/fibrosis of the liver.
- •Age > 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Patients must have acceptable organ and marrow function as defined below:
- •White Blood Cells > 2,000/mcL
- •Absolute Neutrophil Count > 1,000/mcL
- •Platelets > 80,000/mcL
- •Alkaline Phosphatase < 2.5 times institutional upper limit of normal
- •Aspartate Aminotransferase/Alanine aminotransferases < 5 times institutional upper limit of normal
- •INR < 1.5 times institutional upper limit of normal
- •Ability to understand and willingness to sign a written informed consent and HIPAA consent document.
- •Q-T Interval of ≤ 450 ms as measured by EKG.
排除标准
- •Patients with known hypersensitivity to octreotide or somatostatin.
- •Patients who are receiving any other investigational agents.
- •Patients who are taking other medications that prolong QT interval.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant or breast feeding.
研究组 & 干预措施
Octreotide treatment arm
Octreotide will be administered post-operatively until day 5
干预措施: Octreotide (Drug)
Placebo Arm
Normal saline will be administered post-operatively until day 5
干预措施: Placebo (Other)
结局指标
主要结局
Rates of Liver Recovery Will be Determined by Area Under the Curve (AUC) for Total Bilirubin and INR for Each Group
时间窗: 0 to 120 hours post dose
To compare the rates of liver recovery in patients treated with octreotide vs placebo after a major hepatectomy.
次要结局
- Rate of Hepatic Parenchymal Regeneration in Patients Treated With Octreotide Vs Placebo After Major Liver Hepatectomy.(14 weeks)
- Evaluate the Incidence of Post-hepatectomy Liver Failure, Bile Leak, Overall.(3 months)