NCT02262845

Short Term Pancreatic Stenting Registry

A Prospective Multi-Center Registry Using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 246 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Post-ERCP Acute Pancreatitis
• Pancreatic Duct Stricture
• Pancreatic Duct Stones
• Pancreatic Duct Leakage

Interventions

Type	Name	Description
DEVICE	The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers	Used to drain pancreatic ducts

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2014-10-13
• Last updated: 2017-03-21

Locations

7 sites across 4 countries: United States, Germany, India, Netherlands