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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02564965
Other study ID # 14-001390
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 2019
Est. completion date December 2020

Study information

Verified date April 2019
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON).


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Study Design


Intervention

Device:
Double Pigtail Plastic 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
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Outcome

Type Measure Description Time frame Safety issue
Primary Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON) Baseline to 4 months after initiation of endoscopic treatment
Secondary 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
Secondary Symptom resolution (Visual Analogue Scale for pain, gastric outlet obstruction, and weight gain) Baseline to 4 months after initiation of endoscopic treatment
Secondary Decrease in incidence of adverse events Baseline to 4 months after initiation of endoscopic treatment
Secondary Decrease in number of hospital days during treatment course Baseline to 4 months after initiation of endoscopic treatment
Secondary Decrease in total costs of pancreatitis-related health care during treatment course Baseline to 4 months after initiation of endoscopic treatment
See also
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Completed NCT01815489 - Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis
Not yet recruiting NCT04963868 - Timing of Transmural Stent Removal in Necrotizing Pancreatitis N/A
Completed NCT03115918 - Pancreatic Duct Stent for Acute Necrotizing Pancreatitis N/A
Not yet recruiting NCT06380842 - Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy

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