跳至主要内容
临床试验/NCT01902238
NCT01902238Unknown不适用

EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Feasibility and Long Term Outcome

Asan Medical Center2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2013年7月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Do Hyun Park

Associate Professor

Asan Medical Center

研究点 (2)

Loading locations...

相似试验