Rad Predictors for WON

NCT03801070 | Completed

• 1 other identifier: 201707053
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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)

Conditions

Walled Off Pancreatic Necrosis (WON)

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Less than median number necrosectomies

Group one includes patients who underwent less than median number necrosectomies

Procedure: endoscopic drainage of walled off pancreatic necrosis

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

Interventions

endoscopic drainage of walled off pancreatic necrosis PROCEDURE

transmural drainage and mechanical debridement of solid debris (necrosectomy)

At least the median number of necrosectomies; Less than median number necrosectomies

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Oklahoma Medical Center: collaborator
• Northwestern University Chicago Illinois: collaborator
• St. Luke's Hospital, Kansas City, Missouri: collaborator

Study Sites (1)

Washington University School of Medicine in St Louis

St Louis, Missouri, 63010, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 11, 2019
• Study Start: July 14, 2017
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)