NCT02262845|Completed
Short Term Pancreatic Stenting Registry
A Prospective Multi-Center Registry Using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct
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A Prospective Multi-Center Registry Using Plastic Pancreatic Stents for Short Term Drainage of the Pancreatic Duct
Sponsor study identifier
observational
246
4 countries
7
Study Start
February 2015
Actual (reported)Primary Completion
September 2016
Actual (reported)Study Completion
September 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 9, 2014
Actual (reported)October 13, 2014
Actual (reported)February 2015
Actual (reported)September 2016
Actual (reported)September 2016
Actual (reported)Clinical Success: Group A (PEP Risk)
Absence of acute pancreatitis from stent placement through 48 hours post stent placement
Stent placement through 48 hours post stent placement
Clinical Success: Group B (Impaired Pancreatic Duct Drainage)
Absence of acute pancreatitis from stent placement through stent removal and, where applicable, improvement of pain at stent removal compared to baseline
Stent placement through stent removal
Clinical Success: Group C (Pancreatic Duct Leak):
Resolution of pancreatic duct leak at stent removal
Stent Removal
Clinical Success: Group D (Post Pancreatic Surgery)
Absence of pancreatic duct leak and stricture at stent removal
Stent Removal
Serious Adverse Events and all occurrences of acute pancreatitis
Through end of study
Technical Success
Stent Placement
Ease of use
Stent Placement
Removability
Stent Removal
Stent Migration
Through end of study
In subjects deemed at high risk for acute pancreatitis post-endoscopic retrograde cholangiopancreatography (ERCP)
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
In subjects with a pancreatic duct leak
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
Used to drain pancreatic ducts
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This study will examine how well the Advanix Pancreatic stent helps drainage of the pancreas when used per standard-of-practice in many different situations.
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Methodist Dallas Medical Center
Dallas, Texas, 75208, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Evangelisches Krankenhaus Dusseldorf
Düsseldorf, 40217, Germany
Asian Institute of Gastroenterology
Somājigūda, Hyderabad, 500 082, India
Erasmus Medical Center
Rotterdam, 3015 CE, Netherlands
Paul Tarnasky, MD
The Methodist Hospital Research Institute
246 participants (actual enrollment reported by the registry).
First Submitted
October 9, 2014
First Posted
October 13, 2014
Study Start
February 2015
Actual (reported)Clinical Sucess: Group E (Other)
Resolution of the indication for stent placement at stent removal
Stent Removal
In subjects with other indications
Contact the study team to confirm eligibility.
Primary Completion
September 2016
Actual (reported)Study Completion
September 2016
Actual (reported)Last Updated
March 21, 2017
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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