EUS Guided-Celiac Plexus Neurolysis (CPN) for Patients With Unresectable Pancreatic Cancer: A Multi-Center, Randomized, Single-Blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The efficacy of EUS-CPN and analgesic therapy in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy
研究概览
简要总结
The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to decreasing the severity of abdominal pain when compared to analgesic therapy alone.
详细描述
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.
The secondary aims of this study are to evaluate the efficacy of EUS-CPN + analgesic therapy in improvement of quality of life (QOL) of patients with unresectable pancreatic cancer when compared to when compared with analgesic therapy alone, compare pain medication usage between Group 1 when compared to Group 2, and compare the referral for rescue block during the course of the study between Group 1 and Group 2
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Age ≥19 yrs old
- •Abdominal pain typical for pancreatic cancer ≥3/10
- •Abdominal CT radiologically consistent with the diagnosis of pancreatic cancer
- •Pancreatic cancer confirmed by FNA during EUS
- •Inoperability of pancreatic cancer as determined during EUS or prior CT
排除标准
- •Age < 19 yrs old
- •Unable to safely undergo EUS for any reason
- •Coagulopathy (prolongation of prothrombin time > 18 sec, thrombocytopenia <80,000 platelets/ml)
- •Previous CPN or other neurolytic block that could affect pancreatic cancer -related pain or had implanted epidural or intrathecal analgesic therapy
- •Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
- •Potential patient noncompliance (refusing to follow schedule of events)
- •Active alcohol or other drug use or significant psychiatric illness
- •Pregnant or breastfeeding
- •Unable to consent
- •Non-English speaking
结局指标
主要结局
The efficacy of EUS-CPN and analgesic therapy in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy
时间窗: ~ 2 year
次要结局
- To evaluate the efficacy of EUS-CPN and analgesic therapy in improvement of quality of life (QOL)(~2 year)