Randomized Single Blinded Control Trial Comparing EUS Guided Celiac Plexus Block (CPB) Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in Pain Response Over a 6 Month Period of Time Using the VAS Score
研究概览
简要总结
This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus Block (CPB) treatment in comparison to EUS without a pain block administered. All participants will receive medications for pain as needed.
详细描述
The purpose of this study is to assess pain response to EUS guided celiac plexus block treatment compared to no treatment. The Visual Analog Scale (VAS) is the primary measure. Secondary aims include the comparison of quality of life scores, need for narcotics, to assess the effect of EUS-CPB on overall mental state using the Beck's Depression Index, and to assess the effect of EUS-CBP on health care utilization and on employment.
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
- Single (Participant)
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
- •All patients referred to UAB Endoscopy Unit for with known chronic pancreatitis
- •Patients referred to the endoscopy unit with abdominal pain with suspicion of chronic pancreatitis meeting 5 of 9 parenchymal and ductal changes (i.e. lobulations, hyperechoic stranding, hyperechoic foci, cysts, calcification, irregular duct, hyperechoic walls, side branch dilations and ductal calculi).
排除标准
- •Age <19 years
- •Unable to safely undergo EUS for any reason
- •Coagulopathy (INR >1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)
- •Unable to consent
- •Non-English speaking patients.
- •Previously undergone CPB
- •Pregnancy and Breast feeding
- •Patients with ductal strictures, calcification, pancreatic ductal calculi, pseudocysts.
- •Previous pancreatic surgery
- •Previous pseudocyst drainage
- •Other documented causes of abdominal pain.
结局指标
主要结局
Change in Pain Response Over a 6 Month Period of Time Using the VAS Score
时间窗: baseline to 6 months
Pain scores will be assessed by comparing the mean number change using the Visual Analog Scale (VAS) from baseline to 6 month. The scale is 10 - 0, with 10 being agonizing pain and 0 being no pain.
次要结局
- Mean Quality of Life Score Between Each Group at 6 Months(6 months post baseline)
- Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline(baseline to 6 months)
- Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.(baseline to 6 months)
- Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure(baseline to 6 months)
- % of Subjects in Each Group That Are Employed at 6 Months Post Procedure.(baseline to 6 months)
研究者
Charles Mel Wilcox, MD
Professor
University of Alabama at Birmingham