Randomized study of extracorporeal shock wave lithotripsy versus pancreatoscopy-guided laser lithotripsy (SpyGlass DS) for pancreatic ductal stones
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 1. Outcome of pancreatoscopy with laser lithotripsy for pancreatic ductal clearance on ERP
研究概览
简要总结
Pancreatic stones can be managed by surgery, endoscopy, or extracorporeal shock wave lithotripsy. Pancreatic ductal stones have a decreased incidence of successful endoscopic extraction and often require lithotripsy. Many critical patients in whom conventional surgery is a high-risk procedure can be managed by ERCP. Although ERCP with conventional methods is successful in most cases, certain stones are difficult or impossible to manage with these maneuvers. Current guidelines suggest use of extracorporeal shock wave lithotripsy (ESWL) for PD stones. In patients with chronic pancreatitis, ESWL permits stone fragmentation and removal during ERCP with some advantages over laser lithotripsy (LL) and surgery. Recently direct pancreatoscopy using the SpyGlass DS system allows direct visualization of the pancreatic ductal stones and lithotripsy can be performed using Holmium laser. Theoretically this offers several advantages; however, no randomized trials have assessed the usefulness of these modalities or superiority of one over the other. So, we aim to study the outcomes between extracorporeal shock wave lithotripsy versus pancreatoscopy-guided laser lithotripsy (SpyGlass DS) for pancreatic ductal stones in a randomised manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients age >18 years of either sex with a dilated PD with ductal stones in head and proximal body, based on ultrasonography, computed tomography, magnetic resonance imaging, or previous ERCP will be included.
- •Patients who agree to sign the informed consent form.
排除标准
- •Ongoing or Recent pancreatitis <4 weeks
- •Pancreatic malignancy
- •Pancreatic fluid collections
- •Presence of ascites and Pseudocysts
- •Patients with decompensated chronic liver disease
- •Patients with Coagulopathy
- •Patients with Chronic Kidney Disease
- •Pregnancy
- •Past history of pancreatic surgery 10.Isolated tail calculi 11.Patients with multiple strictures.
结局指标
主要结局
1. Outcome of pancreatoscopy with laser lithotripsy for pancreatic ductal clearance on ERP
时间窗: At end of study
2. Outcome of ESWL for pancreatic ductal clearance on ERP
时间窗: At end of study
次要结局
- Safety of Spyglass and ESWL(At end of study)
