EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Feasibility and Long Term Outcome
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Number of participants with treatment response
研究概览
简要总结
The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET
详细描述
Pancreatic neuroendocrine tumor, including insulinoma, increasingly are being encountered in clinical practice. Management of pancreatic NET is challenging because most are asymptomatic but may have malignant potential, and surgical resection of pancreatic neoplasm is associated with substantial morbidity of 20%-40% and a mortality rate of 2%. Management strategy needs to be individualized, applying a risk-benefit analysis to each patient. Recently, pancreatic tissue ablation by EUS-guided injection of ethanol or other chemotherapeutic agents can be performed safely, with few procedure-related complications. Levy et al. demonstrated that EUS-guided ethanol ablation for insulinoma was both safe and feasible, and symptomatic improvement was achieved in 8 of 8 patients (100%). However, previous study have included only a small number of patients and evaluated only short-term outcomes. In addition, lipiodol permits the drug to concentrate in the tumor. To obtain an embolic effect and prevent washout of the ethanol, ethanol/lipiodol mixture is administered into the tumor. The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Pancreas NET(including insulinoma) < 2cm in diameter
- •Poor surgical candidate (involving the head of the pancreas or multifocal NET, advanced comorbidity, age >75 years of age)
- •Refuse to surgery
排除标准
- •Younger than 18 years of age
- •Coagulopathy (INR >1.5, Platelet <50,000)
- •Evidence of active pancreatitis
- •Inability to safely undergo EUS
- •Refuse to participate
结局指标
主要结局
Number of participants with treatment response
时间窗: more than 3 years after procedure
Final tumor viability will be assessed using contrast enhanced CT, and EUS-guided FNA at 3 years after procedure
次要结局
- The number of participants with post-procedure adverse events(until 3 months after procedure)
研究者
Do Hyun Park
Associate Professor
Asan Medical Center
