To Evaluate Perfusion Changes to the Liver Following Pre-Operative Portal Vein Embolization for Patients With Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Perfusion changes to the liver following portal vein embolization (PVE)
研究概览
简要总结
This trial studies the use of computed tomography (CT) perfusion scans in detecting changes in blood flow to the liver after portal vein embolization in patients with liver cancer. CT perfusion scans use a standard contrast drug given by vein to measure blood flow to the liver. CT perfusion scans may predict the rate and amount of growth of new, healthy tissue on one side of the liver after a portal vein embolization and detect change to the size of the liver tumor as result of the procedure.
详细描述
PRIMARY OBJECTIVES:
I. To assess whether perfusion changes to the liver following portal vein embolization (PVE) correlate with hypertrophy of the future liver remnant (FLR).
SECONDARY OBJECTIVES:
I. To assess perfusion changes to liver tumors following PVE. II. To assess whether PVE may affect tumor growth.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 planned to undergo major liver resection for cancer who need PVE to increase the size of the FLR prior to surgery.
- •Patients who are able to understand and give consent to participate in the study.
排除标准
- •Pregnant or nursing.
- •Allergy to iodinated contrast which cannot be safely pre-medicated.
- •History of severe renal dysfunction (glomerular filtration rate [GFR] < 30 mL/min/1.73 square meters). Patients with a GFR between 30-50 mL/min/1.73 square meters will receive the standard contrast-induced nephropathy prophylaxis at our institution (i.e. N-acetylcysteine and sodium bicarbonate [150 mEq/L] in D5W intravenous).
结局指标
主要结局
Perfusion changes to the liver following portal vein embolization (PVE)
时间窗: Baseline up to 6 weeks post PVE
Will assess whether perfusion changes to the liver following PVE correlate with hypertrophy of the future liver remnant (FLR). Perfusion and FLR hypertrophy are two continuous variables. Each patient will serve as his/her own control. Perfusion to the liver (1) before PVE, (2) immediately after PVE, and (3) 3-6 weeks following PVE will be measured and compared. The changes in perfusion will be compared with FLR hypertrophy at the 3-6 week time point to assess correlation.
次要结局
- Changes to tumor cellular proliferation following PVE(Baseline up to 6 weeks post PVE)