Completed

NCT Number: NCT03801070

Rad Predictors for WON

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)

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Key information

Conditions

Walled Off Pancreatic Necrosis (WON)

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine in St Louis

St Louis, Missouri, 63010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic drainage of walled off pancreatic necrosis

Procedure

transmural drainage and mechanical debridement of solid debris (necrosectomy)

Primary outcomes

Identify WON imaging characteristics on cat-scan

Time frame: 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)

Time frame: 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

Northwestern University
St. Luke's Hospital, Kansas City, Missouri
University of Oklahoma Medical Center

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Jan 11, 2019
Registry last updated: Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.