Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of Subjects With Complete or Partial Ablation of the Treated Cyst
研究概览
简要总结
Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was a pilot study to assess safety and efficacy.
The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring hospitalization will occur in <10% of subjects, and 2) EUS guided ethanol injection, with retreatment as necessary, will ablate at least 50% of pancreatic cysts.
详细描述
EUS is performed via the mouth under sedation. After a needle is placed into the pancreas cyst under EUS guidance, an ethanol solution is placed into the cyst via the needle. The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.
After this treatment, usual clinical follow-up is obtained including assessments of the cyst by CT or MRI scans. If a cyst of significant size persists, additional EUS-guided ethanol injections of the cyst were offered.
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, > 1 cm in maximum diameter
- •Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
- •Age > or = 18 years
- •Able to give informed consent
- •Surgical treatment has been considered, and a surgical consultation offered to the patient, but:
- •Subject's cyst does not meet consensus criteria for surgical resection, or
- •Subject is deemed a poor operative candidate, or
- •Ethanol ablation would allow a subtotal rather than total pancreatectomy, or
- •Subject has decided not to undergo surgical treatment.
排除标准
- •Known or suspected pregnancy, or nursing
- •History of pancreatitis within past 3 months
- •Main pancreatic duct is dilated to > 4mm in neck, body, or tail
- •Cyst is known to communicate with the pancreatic duct
- •Cyst has a primarily microcystic architecture on EUS
- •Cyst is immediately adjacent to the main pancreatic duct on EUS
- •Cyst has a connection to the main pancreatic duct seen during EUS
- •During initial cyst aspiration, more fluid is recovered than expected (suggesting communication to the main pancreatic duct)
- •Pancreatic cytology has demonstrated cancer
研究组 & 干预措施
Pancreatic Cyst Ethanol Injection
EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
干预措施: Lidocaine (Drug)
Pancreatic Cyst Ethanol Injection
EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
干预措施: Ethanol (Drug)
结局指标
主要结局
Number of Subjects With Complete or Partial Ablation of the Treated Cyst
时间窗: 1 year after final treatment
Complete or partial ablation of cysts will be defined by the presence of a persistent cystic structure, and its volume and maximum diameter, as determined by cross-sectional imaging studies (CT, MR)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: 1 year after final treatment
Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability
次要结局
未报告次要终点