Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Occurrence of adverse events requiring treatment or hospitalization
研究概览
简要总结
Pancreatic cysts are common, and some pancreas cysts have malignant potential. Usual treatment of these cysts is either observation or surgical removal of part or all of the pancreas. Minimally invasive treatment via endoscopy has been described, using endoscopic ultrasound (EUS) guided ethanol injections. Such studies exclude cysts that communicate with the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol. In this study, pancreas cysts communicating with the main pancreas duct are treated with ethanol via endoscopic retrograde cholangiopancreatography (ERCP) and/or EUS.
详细描述
Subjects will undergo EUS and/or ERCP as outpatients. For cysts shown to communicate with the main pancreas duct, a balloon catheter will be placed in the main pancreatic duct via ERCP. The balloon catheter will isolate the cyst from the main pancreatic duct, allowing ethanol injections of the cyst. A pancreatic duct stent will be placed in some patients, requiring repeat endoscopy for removal at another time.
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
- •Presence of a pancreatic cystic lesion, at least 2 cm in maximum diameter
- •Cyst may communicate, or definitely communicates, with the pancreatic duct (based on prior CT, MR, ERCP, or EUS images)
- •Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
- •Age at least 18 years
- •Able to give informed consent
- •Surgical treatment has been considered and a surgical consultation offered to the patient, OR the subject's cyst does not meet consensus criteria for surgical resection. (Current consensus criteria for resection are one or more of the following: cyst is symptomatic, ≥ 3 cm in diameter, contains a mural nodule, cytology of cyst fluid is positive for malignancy, or main pancreatic duct diameter is > 6 mm.)
排除标准
- •Known or suspected pregnancy, or nursing
- •History of pancreatitis within 3 months prior to study endoscopy procedures
- •Cyst has a primarily microcystic architecture on EUS
结局指标
主要结局
Occurrence of adverse events requiring treatment or hospitalization
时间窗: 3 days, 30 days
Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment
时间窗: 6 months, 12 months
次要结局
未报告次要终点