NCT02564965|WithdrawnFDA Device
Study Stopped
Lack of funding
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Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
February 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
September 29, 2015
Actual (reported)October 1, 2015
Actual (reported)February 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON)
Baseline to 4 months after initiation of endoscopic treatment
Clinical resolution of infection as defined by complete radiographic resolution and/or symptoms of pain and gastric outlet obstruction
Baseline to 4 months after initiation of endoscopic treatment
Symptom resolution (Visual Analogue Scale for pain, gastric outlet obstruction, and weight gain)
Baseline to 4 months after initiation of endoscopic treatment
Decrease in incidence of adverse events
Baseline to 4 months after initiation of endoscopic treatment
Decrease in number of hospital days during treatment course
Baseline to 4 months after initiation of endoscopic treatment
Decrease in total costs of pancreatitis-related health care during treatment course
Baseline to 4 months after initiation of endoscopic treatment
Subjects who have greater than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.
Subjects who have less than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.
Patients will be stratified into two arms (Greater than 50% necrosis or less than 50% necrosis), then will be randomized to either the double pigtail plastic stent or AXIOS metal stent
Patients will be stratified into two arms (Greater than 50% necrosis or less than 50% necrosis), then will be randomized to either the double pigtail plastic stent or AXIOS metal stent
Barham Abu Dayyeh, MD
Mayo Clinic
0 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2015
First Posted
October 1, 2015
Study Start
February 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Organ Dysfunction Changes in Acute Necrotizing Pancreatitis Patients With Sepsis Following Open Necrosectomy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 19, 2019
Record last verified: 2019-04
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Source: ClinicalTrials.gov.
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