Fully Covered Self Expanding Metal Stents (FCSEMS) for Refractory Pancreatic Duct Strictures in Patients With Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis
研究概览
简要总结
The purpose of this study is to document the performance of a new Fully Covered Self Expanding Metal Stents (FCSEMS) for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis.
详细描述
This study is a prospective, single arm, pre-approval study. Treatment of 10 patients will take place at 1-3 clinical centers in two phases. Phase 1 will include treatment of five patients with a three month stent indwell period at one clinical center. Phase 2 will include treatment of five additional patients with a 3-6 month stent indwell period at 1-3 clinical centers. Expected duration of participation for each patient is approximately 27 months for Phase 1 and approximately 27-30 months for Phase 2. All patients, regardless of phase, will be followed for 24 months after stent removal. Post-removal follow-up visits will occur at 1, 3, 6, 12, 18 and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age 18 or older
- •Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study
- •Chronic pancreatitis of Cremer Type IV (Segmental pancreatitis of the head of the pancreas). See Appendix for Cremer classifications.
- •Improvement of pancreatic pain during previous placement of a single pancreatic plastic stent
- •At least one of the following:
- •Abdominal pain most probably related to chronic pancreatitis
- •Recurrent dominant main pancreatic duct stricture in the head of the pancreas after prior indwell of pancreatic plastic stent(s) if pain score was available prior to preceding stent therapy. Recurrent stricture to be visually assessed at endoscopy and confirmed by recurrent main pancreatic duct dilatation at MRCP.
- •Relapsing pain due to pancreatic duct stent blockage (with only one stent in place)
- •Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement with informed patient consent.
排除标准
- •Strictures caused by malignancies
- •Biliary strictures caused by chronic pancreatitis
- •Perforated duct.
- •Ansa pancreatica or H anatomy
- •Pancreatic duct stenoses not located in the head of the pancreas
- •Failed access during an attempted ERCP on a prior date
- •Prior pancreatic metal stent(s)
- •Concurrent ESWL (Extracorporeal Shock Wave Lithotripsy) during the same treatment session
- •Patients for whom endoscopic techniques are contraindicated.
- •Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
- •Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational center that
结局指标
主要结局
Decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis
时间窗: 3 months after study stent removal
Clinical success defined as decrease of pain caused by refractory benign pancreatic duct strictures secondary to chronic pancreatitis 3 months after stent removal compared to baseline prior to stent indwell period.
次要结局
- Stent placement success(Study Stent Placement Procedure)
- Stent removal success(Study Stent Removal)
- Number of device events(Duration of study participation, an average of 27-30 months)
- Occurrence and severity of serious adverse events related to the stenting procedure, to the indwelling stent and/or to stent removal(Duration of study participation, an average of 27-30 months)
- Change of pain medication intake(Duration of study participation, an average of 27-30 months)
- Time to Recurrence of Stricture(Duration of study participation, an average of 27-30 months)
- Reason for additional intervention within pancreatic duct(Duration of study participation, an average of 27-30 months)
- Stricture resolution of pancreatic duct after stent removal(Study Stent Removal)
- For patients who proceed to surgery, impact of prior SEMS on surgical outcomes.(Up to surgery)
- Stricture Resolution at stent removal(Study Stent Removal)
- Type of additional intervention within pancreatic duct(Duration of study participation, an average of 27-30 months)
- Stent functionality(Up to time of study stent removal,average of 3-6 months on study)
- Timing of additional intervention within pancreatic duct(Duration of study participation, an average of 27-30 months)