Clinical trial NCT03801070: Rad Predictors for WON
Official title: Radiological Predictors of Failure of Endoscopic Therapy or Need For Multiple Endoscopic Procedures in Patients With Walled Off Pancreatic Necrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Walled Off Pancreatic Necrosis (WON)
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Oklahoma Medical Center
name: Northwestern University Chicago Illinois
name: St. Luke's Hospital, Kansas City, Missouri
First posted: 2019-01-11
Enrollment: 104
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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)

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)


Eligibility criteria: 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

Primary outcomes:
measure: Identify WON imaging characteristics on cat-scan
timeFrame: through study completion, an average of 260 days
measure: Endoscopic course (total number and type of endoscopic treatments required for resolution of walled off necrosis, occurrence of treatment related complications)
timeFrame: through study completion, an average of 260 days
measure: Clinical course (number of hospital readmissions during treatment, rates of walled off necrosis resolution, rates of walled off necrosis related death)
timeFrame: through study completion, an average of 260 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St Louis
state: Missouri
Study officials:
References: