Short Term Pancreatic Stenting Registry

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

Inclusion criteria

• 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

Exclusion criteria

• 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.