Rad Predictors for WON

Study Overview
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Brief Summary
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This is a retrospective chart review study examining 1) demographic data such as age, sex, etiology of pancreatitis 2) clinical data including radiological characteristics of walled off pancreatic necrosis, walled off necrosis related admissions and readmission following endoscopic drainage, surgical or percutaneous procedures performed for the management of walled off pancreatic necrosis, and clinical outcomes following treatment of WON (including hospital readmissions, WON resolution, procedure complications, WON related death) 3) endoscopy data including indication for initial endoscopic drainage and subsequent endoscopic procedures performed for management of walled off necrosis (including additional EGD's, endoscopic drainage procedures, and/or necrosectomy)

Official Title
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Radiological Predictors of Failure of Endoscopic Therapy or Need For Multiple Endoscopic Procedures in Patients With Walled Off Pancreatic Necrosis

Conditions
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Walled Off Pancreatic Necrosis (WON)

Intervention / Treatment
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* Procedure: endoscopic drainage of walled off pancreatic necrosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age who underwent endoscopic drainage of walled off pancreatic necrosis Patients who did not require further intervention (either surgical, percutaneous, or endoscopic) following endoscopic drainage Patients who required further intervention for walled off pancreatic necrosis (either surgical, percutaneous, or endoscopic) following endoscopic drainage. Patients who underwent percutaneous or surgical interventions prior to endoscopic drainage Exclusion Criteria: Pancreatic pseudocysts without any solid debris Under 18 years of age at the time of endoscopic drainage

Ages Eligible for Study
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Minimum Age: 19 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Less than median number necrosectomies<br>Group one includes patients who underwent less than median number necrosectomies | Procedure: endoscopic drainage of walled off pancreatic necrosis<br>* transmural drainage and mechanical debridement of solid debris (necrosectomy)<br>|
| At least the median number of necrosectomies<br>Group two includes patients who underwent at least the median number of necrosectomies | Procedure: endoscopic drainage of walled off pancreatic necrosis<br>* transmural drainage and mechanical debridement of solid debris (necrosectomy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify WON imaging characteristics on cat-scan | Characteristics on cat-scan that are predictive of requiring multiple endoscopic procedures, percutaneous drainage, and/or surgical intervention for management of walled off pancreatic necrosis | through study completion, an average of 260 days | 
| Endoscopic course (total number and type of endoscopic treatments required for resolution of walled off necrosis, occurrence of treatment related complications) | Imaging classification method to efficiently report these imaging characteristics | through study completion, an average of 260 days | 
| Clinical course (number of hospital readmissions during treatment, rates of walled off necrosis resolution, rates of walled off necrosis related death) | Characteristics to develop a predictive model that will help to identify patients at high risk for requiring multiple endoscopic procedures, percutaneous drainage, and/or surgical intervention for management of walled off pancreatic necrosis. | through study completion, an average of 260 days |