Short Term Pancreatic Stenting Registry
Short Term Pancreatic Stenting Registry
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.
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:

 1. Subjects age 18 or older.

 2. Subjects who require pancreatic drainage and are amenable to endoscopic techniques.

 3. 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.

 4. Subjects satisfying at least one of the following clinical presentations:

 1. high risk of acute pancreatitis post ERCP

 2. 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

 3. need to maintain proper pancreatic duct drainage in the presence of a pancreatic
 duct leak

 4. 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:

 1. Subjects for whom endoscopic techniques are contraindicated.

 2. Subjects with known sensitivity to any components of the stents or delivery systems.

 3. Subjects with coagulopathy outside of what is deemed acceptable for ERCPs per standard
 of practice

 4. Subjects who are currently enrolled in another investigational study that would
 directly interfere with the current study, without prior written approval from the
 sponsor.

 5. 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.