EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Efficacy: Cyst Resolution
研究概览
简要总结
Pancreatic cysts are becoming diagnosed more frequently due to the increased use and sensitivity of imaging. A subset of these cysts are pre-cancerous, therefore suggested treatment is surgery for removal. However, surgery involves significant risks and emerging opinion suggests that not all cysts need to be surgically removed. An alternative therapy would be ideal, in particular for those where surgical risk outweighs the benefits of resection. Ethanol and paclitaxel ablation of pancreatic cysts may be a viable alternative to surgical resection.
Our hypothesis is that ethanol with paclitaxel ablation is a safe and effective method for treatment in those with per-cancerous, mucinous pancreatic cysts.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mucinous cystic neoplasm defined by cyst fluid analysis [23, 28]:
- •CEA > 192ng/mL
- •Amylase < 800 IU/L
- •Cytology negative for malignant cells
- •No communication of cyst with pancreatic duct on 2 imaging studies (EUS, CT, MRCP, or ERCP)
- •Cyst size > 15mm but <50mm
- •3 or fewer cyst compartments
- •Age ≥18 and ≤ 85
排除标准
- •Inability to safely undergo EUS examination with standard conscious sedation
- •Inability for safe FNA needle insertion into the cyst (eg: intervening vessel)
- •Inability to undergo MRI (metal implants/cardiac pacemaker/defibrillator, claustrophobia)
- •Coagulopathy (INR>1.5 or platelets<50)
- •Active pancreatitis or pancreatic infection
- •Active sepsis/bacteremia
- •Inability to provide informed consent
- •Breastfeeding women
研究组 & 干预措施
Ethanol and Paclitaxel Injection
All patients will receive at least one treatment with alcohol and paclitaxel.
干预措施: Ethanol and Paclitaxel Injection (Drug)
结局指标
主要结局
Efficacy: Cyst Resolution
时间窗: 6 months
Proportion of patients without cysts at 6 months
Efficacy: Degree of Ablation
时间窗: 6 months
Degree of cyst epithelial ablation in those undergoing resection
次要结局
- Safety(30 day)
- Efficacy: Change of tumor markers(12 month)
- Efficacy: Cyst Resolution(24 months)
研究者
Brian Yan
Assistant Professor of Medicine
Lawson Health Research Institute