Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy for Geriatric Patients With Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 入组人数
- 1,404
- 试验地点
- 1
- 主要终点
- P-ESWL complications
研究概览
简要总结
Pancreatic extracorporeal shock wave lithotripsy (P-ESWL) is recommended as the first-line treatment for pancreatic stones. However, how well P-ESWL performs in geriatric patients remains unclear. The investigators aimed to evaluate the safety and efficacy of P-ESWL for geriatric patients with chronic pancreatitis.
详细描述
This prospective observational study was conducted in patients with painful chronic pancreatitis who underwent P-ESWL. Patients aged over 65 years were included in the geriatric group; patients aged under 65 years who underwent P-ESWL in the same period were assigned to the control group. For investigation of long-term follow-up, the geriatric group were matched with patients from the control group in a 1:1 ratio. The primary outcomes were P-ESWL complications and pain relief. The secondary outcomes included: stone clearance, physical and mental health, quality of life score, and body weight.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with painful chronic pancreatitis and radiopaque stones of ≥5mm.
排除标准
- •Patients with a suspected or established malignant mass or pancreatic ascites, and pregnant patients.
结局指标
主要结局
P-ESWL complications
时间窗: April 30, 2016
The complications after P-ESWL. Including post-ESWL pancreatitis, bleeding, infection, steinstrasse, and perforation. The degree of these complications will also be measured.
Pain relief by the end of follow-up period
时间窗: April 30, 2018
Participants will be followed up annually either by return visit or telephone call. Condition of abdominal pain or acute pancreatitis attack during follow-up will be measured. Pain relief at the end of the follow-up period was classified as complete relief (Izbicki pain score≤10) or partial relief (Izbicki pain score \>10 after a decrease of \>50%)
次要结局
- Body weight(April 30, 2018)
- Physical and mental health assessed by SF-36 questionnaire(April 30, 2018)
- Stone clearance as assessed by ERCP performed post-ESWL(April 30, 2016)
- Quality of life score assessed by the patient(April 30, 2018)
研究者
Zhaoshen Li
Director of Gastroenterology Dept.
Changhai Hospital