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Lack of funding
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The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Greater than 50% Necrosis | Other | 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. |
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| Less than 50% Necrosis | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double Pigtail Plastic Stent | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON) | Baseline to 4 months after initiation of endoscopic treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barham Abu Dayyeh, MD | Mayo Clinic | Principal Investigator |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D019283 | Pancreatitis, Acute Necrotizing |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| AXIOS Metal Stent | Device | 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 |
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| 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 |