Acute pancreatitis is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis. Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.
Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis. Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. Endoscopic treatment involves the drainage of the fluid collection into the stomach or duodenum by placement of metal or plastic stents. If clinically indicated, endoscopic necrosectomy is also performed, which is the removal of devitalized pancreatic tissue using the endoscope. Currently the treatment success rate of endoscopic treatment of pancreatic fluid collections exceeds 90%. The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.
Study Type
OBSERVATIONAL
Enrollment
1,000
Patients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy
Orlando Health
Orlando, Florida, United States
RECRUITINGTreatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.
Time frame: 3 years
Treatment success
Rate of treatment success, defined as the resolution of pancreatic fluid collection on CT scan in association with clinical resolution of symptoms at 6-months from index intervention.
Time frame: 6 months
Number and type of interventions performed
Number of interventions performed to achieve treatment success
Time frame: 6 months
Need for surgical intervention
Need for any surgical intervention in patients undergoing endoscopic therapy for pancreatic fluid collections.
Time frame: 6 months
Technical success of endoscopic interventions in pancreatic fluid collections.
Technical success of endoscopic interventions in pancreatic fluid collections.
Time frame: 6 months
Inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.
Rate of inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.
Time frame: 6 months
Disease-related adverse events
Rate of disease-related adverse events
Time frame: 6 monthts
Procedure-related adverse events
Procedure-related adverse events in patients undergoing endoscopic management of pancreatic fluid collection
Time frame: 6 months
Timing of intervention
Intervention at 4 weeks since onset of pancreatitis (traditional approach) versus intervention when the area of necrosis is contained or only partially encapsulated.
Time frame: 6 months
Hounsfield units of the pancreatic fluid collection
Impact of hounsfield units in the necrotic collection on endoscopic intervention
Time frame: 6 months
Impact of partial versus full encapsulation of pancreatic fluid collections
Impact of partial versus full encapsulation of pancreatic fluid collections on endoscopic intervention
Time frame: 6 months
Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome
Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome
Time frame: 3 years
Hospital admission
Rate of hospital readmissions due to disease-related or procedure-related events in patients undergoing endoscopic therapy for pancreatic fluid collections.
Time frame: 6 months
Disease recurrence
Rate of disease recurrence in patients undergoing endoscopic management of pancreatic fluid collections
Time frame: 3 years
Diabetes
Rate of diabetes
Time frame: 3 years
Exocrine pancreatic insufficiency
Rate of exocrine pancreatic insufficiency
Time frame: 3 years
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