Status:
COMPLETED
Short Term Pancreatic Stenting Registry
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Post-ERCP Acute Pancreatitis
Pancreatic Duct Stricture
Eligibility:
All Genders
18+ years
Brief 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 ...
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 u...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT02262845
Start Date
February 1 2015
End Date
September 1 2016
Last Update
March 21 2017
Active Locations (7)
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1
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
3
Methodist Dallas Medical Center
Dallas, Texas, United States, 75208
4
Virginia Mason Medical Center
Seattle, Washington, United States, 98101