Extracorporeal Shock Wave Lithotripsy Versus Single Operator Pancreatoscopy and Intraductal Lithotripsy for the Treatment of Pancreatic Duct Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Mean number of lithotripsy and ERCP procedures needed for clearance of stones or in the attempt to clear stones
研究概览
简要总结
Pancreatic duct stones can cause obstruction of the main pancreatic duct leading to abdominal pain, exocrine pancreatic insufficiency, and recurrent acute pancreatitis. By removing pancreatic duct stones, the obstruction can be relieved, and this can improve symptoms. Small stones can be removed with standard endoscopic retrograde cholangiopancreatography (ERCP) and stone removal, but larger stones may require lithotripsy to break up the stone before removal. The two current methods of lithotripsy include extracorporeal shock wave lithotripsy (ESWL) and single operator pancreatoscopy with intracorporeal lithotripsy (SOPIL).
ESWL is based on concentrating shock wave energy to the stone through an external device. SOPIL is a newer technique based on direct visualization of the stone during ERCP and targeting the stone with a shock wave catheter. There are currently no studies directly comparing ESWL to SOPIL for breaking apart stones in the pancreatic duct, so this study is designed to compare the two techniques.
Objective #1: Obtain pilot data to determine the optimal method of clearing large MPDS Objective #2: Obtain pilot data to assess how effective large MPDS clearance is in improving long term patient centered outcomes Objective #3: Obtain pilot data to measure the cost effectiveness of large MPDS clearance
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
- 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
- •MPDS located in the head, neck, or neck/body junction of the pancreas
- •MPDS > 5 mm in size
- •Abdominal CT scan, Endoscopic ultrasound, or prior ERCP demonstrating MPDS
- •Abdominal pain related to MPDS
- •Previously failed ERCP performed with intent to clear MPDS, OR MPDS determined by treating physicians to not be amenable to clearance by standard ERCP techniques
排除标准
- •MPDS predominantly located in the body and tail of pancreas
- •Any obstructing MPDS > 5 mm located in the body and tail of pancreas
- •Known pancreatic head stricture precluding passage of the pancreatoscope with endoscopic stone extraction based on prior imaging or prior ERCP
- •Pancreatic head mass
- •Impacted MPDS located at the pancreatic duct orifice
- •Prior attempts at ESWL or SOPIL for MPDS
- •Walled off pancreatic necrosis
- •Active alcohol use, defined as any alcohol use within 2 months
- •Surgically altered anatomy (see text)
- •Gastric outlet obstruction or obstruction precluding passage of the endoscope
- •Standard contraindications to ERCP
- •Implanted cardiac pacemakers or defibrillators
- •Known calcified aneurysms in the path of the shockwave
- •Age < 18 years, pregnancy, incarceration, unwillingness/inability to provide informed consent, or anticipated inability to follow protocol
结局指标
主要结局
Mean number of lithotripsy and ERCP procedures needed for clearance of stones or in the attempt to clear stones
时间窗: Up to 24 weeks
Combined lithotripsy and ERCP procedures
Procedural related adverse events
时间窗: Up to 24 weeks
This will be described as a proportion of patients who develop post-procedure pancreatitis, bleeding, infection, perforation, organ injury, symptomatic hematoma, or Steinstrasse resulting in acute stone impaction at the papilla
Technical success of complete or partial clearance (≥80% stone clearance) of large main pancreatic duct stone
时间窗: Up to 24 weeks
This will be described as a proportion of patients with stone clearance. This is defined by the endoscopist's interpretation of the pancreatogram during the time of ERCP and/or subsequent imaging studies. Two blinded endoscopists will review the final pancreatogram to confirm clearance of MPDS
次要结局
- Change in quality of life based on chronic pancreatitis specific instruments: PANQOLI(through study completion, an average of 1 year)
- Change in exocrine insufficiency(through study completion, an average of 1 year)
- Change in pain scores(through study completion, an average of 1 year)
- Change in narcotic pain medication usage(through study completion, an average of 1 year)
研究者
Jeffrey Easler
Associate Professor of Medicine
Indiana University