Necrotizing Pancreatitis
Conditions
Keywords
Acute Necrotizing Pancreatitis, Walled-Off Pancreatic Necrosis
Brief summary
The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON).
Interventions
DEVICEDouble 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
DEVICEAXIOS 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
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adult (\> 18 yo) patients * With symptomatic walled- off pancreatic necrosis in which an endoscopic approach is appropriate based on cross-sectional imaging * Must have solid necrotic material present in their pancreatic fluid collection as determined by MRI, EUS, or direct transluminal endoscopic imaging of the collection
Exclusion criteria
* Previous intervention for pancreatic necrosis (surgical, percutaneous, or endoscopic) * Indication for emergency laparotomy (compartment syndrome, bowel ischemia, bleeding, or perforation of a GI lumen) * Uncorrectable coagulopathy.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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) | 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 |
Outcome results
None listed