Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis

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

Official Title
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Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis: A Prospective, Randomized Noninferiority Trial.

Conditions
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Necrotizing Pancreatitis

Intervention / Treatment
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* Device: Double Pigtail Plastic Stent
* Device: AXIOS Metal Stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Greater than 50% Necrosis<br>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. | Device: Double Pigtail Plastic Stent<br>* 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<br>Device: AXIOS Metal Stent<br>* 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<br>* Other names: Large caliber- self-expanding metal stent;|
| Other: Less than 50% Necrosis<br>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. | Device: Double Pigtail Plastic Stent<br>* 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<br>Device: AXIOS Metal Stent<br>* 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<br>* Other names: Large caliber- self-expanding metal stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Necrotizing Pancreatitis, Walled-Off Pancreatic Necrosis