Rad Predictors for WON

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

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)

Study Overview

• Status: Completed
• Conditions: Walled Off Pancreatic Necrosis (WON)
• Intervention / Treatment: Procedure: endoscopic drainage of walled off pancreatic necrosis

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63010
      • Washington University School of Medicine in St Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with organized collections that contain both solid and liquid debris and arise from necrotizing pancreatitis, referred to as walled off pancreatic necrosis (WON)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Less than median number necrosectomies; Group one includes patients who underwent less than median number necrosectomies	Procedure: endoscopic drainage of walled off pancreatic necrosis; transmural drainage and mechanical debridement of solid debris (necrosectomy)
At least the median number of necrosectomies; Group two includes patients who underwent at least the median number of necrosectomies	Procedure: endoscopic drainage of walled off pancreatic necrosis; transmural drainage and mechanical debridement of solid debris (necrosectomy)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: University of Oklahoma Medical Center; Northwestern University Chicago Illinois; Saint Luke's Hospital University of Missouri-Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 20, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pancreatic Diseases; Pancreatitis; Necrosis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: 201707053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No