Short Term Pancreatic Stenting Registry

Completed

Conditions studied: Post-ERCP Acute Pancreatitis, Pancreatic Duct Stricture, Pancreatic Duct Stones, Pancreatic Duct Leakage

In brief

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.

Key facts

Study ID

NCT02262845

Run by

Boston Scientific Corporation

People needed

246

Starts

2015-02-01

Expected to finish

2016-09-01

Last updated by the study team

2017-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Temple University School of Medicine — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Methodist Dallas Medical Center — Dallas, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Evangelisches Krankenhaus Dusseldorf — Düsseldorf, Germany
• Asian Institute of Gastroenterology — Somājigūda, Hyderabad, India
• Erasmus Medical Center — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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