Rad Predictors for WON

Walled Off Pancreatic Necrosis (WON) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801070
• Other study ID #: 201707053
• Status: Completed
• Start date: July 14, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: July 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Necrosis
• Walled Off Pancreatic Necrosis (WON)

Intervention

Procedure:
• endoscopic drainage of walled off pancreatic necrosis
transmural drainage and mechanical debridement of solid debris (necrosectomy)

Locations

Country	Name	City	State
United States	Washington University School of Medicine in St Louis	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	Northwestern University Chicago Illinois, Saint Luke's Hospital University of Missouri-Kansas City, University of Oklahoma Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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