Post-ERCP Acute Pancreatitis Clinical Trial
Official title:
A Prospective Multi-Center Registry Using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct
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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
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