Comparison of ESWL Alone and ESWL Combined With Endoscopic Drainage of the Main Pancreatic Duct for Painful Chronic Pancreatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Relapse of pain at 2 years
研究概览
简要总结
Endoscopy is an established method of treatment for painful obstructive calcified pancreatitis. It involves the disintegration of calcifications using extracorporeal shock wave lithotripsy (ESWL) followed by endoscopic removal of stone fragments possibly associated with stent insertion. A pilot study suggests that ESWL alone relieves pain in calcified chronic pancreatitis (CP). The aim of this study is to compare both techniques in a randomized controlled trial.
详细描述
Endoscopic drainage of the main pancreatic duct is an established method of treatment of painful obstructive calcified chronic pancreatitis (CP). It involves disintegration of calcifications using extracorporeal shock wave lithotripsy (ESWL) followed by endoscopic removal of stone fragments, possibly associated with stent insertion. A pilot study suggests that ESWL alone in calcified CP is followed by spontaneous elimination of stone fragments and pain relief, without sphincterotomy. After ESWL alone, the exocrine function was found to return to normal values in some cases. Potential benefits include lower costs and morbidity as well as wider availability compared to endoscopic techniques.
The primary outcome of this randomized controlled trial is to compare the relapse of pain at 2 years after treatment with ESWL alone or endoscopic treatment, consisting of ESWL followed by endoscopic stone extraction. Secondary outcomes include a comparison of technical results (as assessed by abdominal CT Scan 1 week after the last intervention and secretin-enhanced magnetic resonance at 1 month), complication rates, and treatment-related costs in both groups.
Patients are eligible to participate in the study according to the following criteria:
Inclusion criteria :
- painful chronic pancreatitis (abdominal pain attack during the preceding 12 months);
- at least 1 calcified stone greater than 4 mm in one of its axes in the cephalic or corporeal portion of the main pancreatic duct with upstream duct dilation;
- written informed consent obtained from the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Painful chronic pancreatitis (>1 abdominal pain attack during the preceding 12 months)
- •At least 1 calcified stone greater than 4 mm in one of its axes in the cephalic or corporeal portion of the main pancreatic duct (MPD) with upstream duct dilation
- •Written informed consent obtained from the patient
排除标准
- •History of treatment of the pancreas using ESWL, endoscopy, or surgery
- •Pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT scan
- •Alkaline phosphatase levels greater than twice the upper limit of normal values or signs of cholangitis
- •Age below 18 years
- •Pregnancy or lactation
结局指标
主要结局
Relapse of pain at 2 years
次要结局
- Complication rate at 1 month
- Diameter of the main pancreatic duct at 1 month
- Treatment-related costs of initial intervention and during follow-up