Randomized Trial Comparing Endoscopy and Surgery for Pancreatic Cyst-gastrostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy
研究概览
简要总结
Patients with pancreatitis can develop inflammatory fluid collection around the pancreas called pseudocysts. Pseudocysts may cause abdominal pain when they are more than 6cm in size. These pseudocysts can be treated (drained) by surgery or by endoscopy. Both treatment options are the current standard-of-care at all institutions around the World. The aim of this study is to identify the better of the two techniques, surgery versus endoscopy, for treatment of patients with pancreatic pseudocysts. This will be done by comparing a) the rates of pseudocyst recurrence b) quality of life of patients following treatment and c) cost associated with treatment, between both treatment modalities.
详细描述
The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer will decrease the severity of abdominal pain when compared to analgesic therapy alone. The specific primary aim of this study is to evaluate the efficacy of EUS-CPN + analgesic therapy (Group 1) in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy (Group 2). The hypothesis will be tested by comparing the changes in reported pain severity between those who receive EUS-CPN in addition to analgesic therapy as compared to analgesic therapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 19yrs
- •able to provide informed consent
- •pancreatic pseudocyst by CT
排除标准
- •age < 19yrs
- •unable to consent
- •pancreatic abscess or necrosis
结局指标
主要结局
Compare median time to pseudocyst recurrence between patients undergoing EUS or Surgical Cysto-gastrostomy
时间窗: 24 months
次要结局
- Quality of Life following treatment which will be assessed on a 3-month basis for 24-months using the SF-36 questionnaire(24 months)
- Median time to pseudocyst recurrence at 24 month follow-up.(24 months)
研究者
Shyam Varadarajulu
Principal Investigator
University of Alabama at Birmingham