Predictors of Pain Relief and Stone Fragmentation in Patients Undergoing Extra Corporeal Shock Wave Lithotripsy for Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of patients having persistent pain
研究概览
简要总结
Extra corporeal shock wave therapy (ESWL) is recommended for pain management in patients with stone formation in pancreatic duct. ESWL can cause complete stone fragmentation and removal in 70% patients, associated with 85 to 90% pain relief.
Investigators aim to study, predictors pain relief in patients who undergo ESWL, to find out which patients will improve and which patients won't improve in terms of pain.
详细描述
The study will be a single center observational study.
General information of the patient in form of duration of symptoms and duration of diagnosis,exocrine and endocrine insufficiency. Imaging findings such as main pancreatic duct stone,size,parenchymal calcification , ductal stricture and its location, using any medications such as antioxidants and pain killers .
The pain score will be estimated by Izbicki's pain score in last 6 months. Patients will receive standard of care during study period, and they won't receive any experimental therapy.
After 6months of ESWL further general information of the patient any addictions, a formal imaging and determining main pancreatic duct stone ,size ,calcifications and strictures and also usage of any medications for decreasing pain.
Pain will be calculated by Izbick's pain score in last 6 months . Comparing pain score and information investigators will evaluate predictive factors of pain relief after ESWL by logistic regression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Chronic pancreatitis patients undergoing ESWL
排除标准
- •Patients with multiple pancreatic duct stones
- •Patients with multiple pancreatic duct strictures
- •Pancreatic head mass
- •Patients with ascites
- •Pregnancy
- •Patients not giving consent for participation
- •Pseudocyst
结局指标
主要结局
Percentage of patients having persistent pain
时间窗: 6 months
Patients with persistent pain after 6 months of ESWL will be calculated
次要结局
未报告次要终点