A Prospective Multi-Center Registry Using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 7
- 主要终点
- Clinical Success: Group A (PEP Risk)
研究概览
简要总结
The purpose of this study is to document clinical utility and distribution of indications for short term pancreatic stenting, and stent type preference by indication at tertiary referral centers with expertise in pancreatic endotherapy.
详细描述
The study is designed as an all-comer, prospective, multi-center, consecutive cohort series, open-label study.
Detailed objective: To confirm the clinical utility of Advanix™ Pancreatic Stents when used per standard of practice to facilitate pancreatic duct drainage in the following clinical presentations:
- Group A: PEP Risk - In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP)
- Group B: Impaired Pancreatic Duct Drainage - In subjects with a pancreatic duct stricture and/or pancreatic duct stones and/or pancreatic duct sludge or debris, possibly, but not exclusively before or after ESWL or before pancreatic surgery
- Group C: Pancreatic Duct Leak - In subjects with a pancreatic duct leak
- Group D: Post Pancreatic Surgery - In subjects at risk of pancreatic duct leak or strictures after resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy
- Group E: Other - In subjects with other indications
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects age 18 or older.
- •Subjects who require pancreatic drainage and are amenable to endoscopic techniques.
- •Subjects willing and able to comply with the study procedures and follow up schedule and willing to provide written informed consent to participate in the study.
- •Subjects satisfying at least one of the following clinical presentations:
- •high risk of acute pancreatitis post ERCP
- •impaired pancreatic duct drainage and pain associated with a pancreatic duct dominant stricture and/or stones and/or sludge/debris, possibly before ESWL or before pancreatic surgery
- •need to maintain proper pancreatic duct drainage in the presence of a pancreatic duct leak
- •need to maintain proper pancreatic duct drainage after surgical resection of a pancreatic lesion close to the main pancreatic duct or at the level of the pancreatico-jejunostomy after pancreatico-duodenectomy
排除标准
- •Subjects for whom endoscopic techniques are contraindicated.
- •Subjects with known sensitivity to any components of the stents or delivery systems.
- •Subjects with coagulopathy outside of what is deemed acceptable for ERCPs per standard of practice
- •Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.
- •Subjects unable or refusing to comply with the follow-up schedule including subject living at such a distance from the investigational center that attending follow-up visits would be unusually difficult or burdensome.
结局指标
主要结局
Clinical Success: Group A (PEP Risk)
时间窗: Stent placement through 48 hours post stent placement
Absence of acute pancreatitis from stent placement through 48 hours post stent placement
Clinical Success: Group B (Impaired Pancreatic Duct Drainage)
时间窗: Stent placement through stent removal
Absence of acute pancreatitis from stent placement through stent removal and, where applicable, improvement of pain at stent removal compared to baseline
Clinical Success: Group C (Pancreatic Duct Leak):
时间窗: Stent Removal
Resolution of pancreatic duct leak at stent removal
Clinical Success: Group D (Post Pancreatic Surgery)
时间窗: Stent Removal
Absence of pancreatic duct leak and stricture at stent removal
Clinical Sucess: Group E (Other)
时间窗: Stent Removal
Resolution of the indication for stent placement at stent removal
次要结局
- Serious Adverse Events and all occurrences of acute pancreatitis(Through end of study)
- Technical Success(Stent Placement)
- Ease of use(Stent Placement)
- Removability(Stent Removal)
- Stent Migration(Through end of study)
- Reintervention(Through end of study)
- Stent type preference(Stent Placement)