Rad Predictors for WON

Completed

• Conditions: Walled Off Pancreatic Necrosis (WON)
• Interventions: Procedure: endoscopic drainage of walled off pancreatic necrosis

• Registration Number: NCT03801070
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-14
• Primary Completion: 2017-09-01
• Study Completion: 2017-12-01
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-20
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

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Exclusion Criteria

• Pancreatic pseudocysts without any solid debris
• Under 18 years of age at the time of endoscopic drainage

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
At least the median number of necrosectomies	endoscopic drainage of walled off pancreatic necrosis	Group two includes patients who underwent at least the median number of necrosectomies
Less than median number necrosectomies	endoscopic drainage of walled off pancreatic necrosis	Group one includes patients who underwent less than median number necrosectomies

Primary Outcome Measures

Name	Time	Method
Identify WON imaging characteristics on cat-scan	through study completion, an average of 260 days	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
Endoscopic course (total number and type of endoscopic treatments required for resolution of walled off necrosis, occurrence of treatment related complications)	through study completion, an average of 260 days	Imaging classification method to efficiently report these imaging characteristics
Clinical course (number of hospital readmissions during treatment, rates of walled off necrosis resolution, rates of walled off necrosis related death)	through study completion, an average of 260 days	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.

Trial Locations

Locations (1)

Washington University School of Medicine in St Louis; 🇺🇸 Saint Louis, Missouri, United States