Acute Pancreatitis, Pancreatic Necrosis, Pancreatic Pseudocyst
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEndoscopic management of pancreatic fluid collections
Patients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy
Sponsors
Orlando Health, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * All patients undergoing endoscopic treatment of pancreatic fluid collections
Exclusion criteria
* Age \< 18 years * Patients who did not receive endoscopic treatment of pancreatic fluid collections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections according to timing of treatment. | 6 months | Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections is assessed as a composite measure consisting of 1) adverse events or 2) need for hospital admission due to underlying disease or procedure-related adverse events, in patients undergoing endoscopic treatment of pancreatic fluid collections, according to timing of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success | 6 months | 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. |
| Number and type of interventions performed | 6 months | Number of interventions performed to achieve treatment success |
| Need for surgical intervention | 6 months | Need for any surgical intervention in patients undergoing endoscopic therapy for pancreatic fluid collections. |
| Technical success of endoscopic interventions in pancreatic fluid collections. | 6 months | Technical success of endoscopic interventions in pancreatic fluid collections. |
| Inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections. | 6 months | Rate of inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections. |
| Disease-related adverse events | 6 monthts | Rate of disease-related adverse events |
| Procedure-related adverse events | 6 months | Procedure-related adverse events in patients undergoing endoscopic management of pancreatic fluid collection |
| Timing of intervention | 6 months | Intervention at 4 weeks since onset of pancreatitis (traditional approach) versus intervention when the area of necrosis is contained or only partially encapsulated. |
| Hounsfield units of the pancreatic fluid collection | 6 months | Impact of hounsfield units in the necrotic collection on endoscopic intervention |
| Impact of partial versus full encapsulation of pancreatic fluid collections | 6 months | Impact of partial versus full encapsulation of pancreatic fluid collections on endoscopic intervention |
| Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome | 6 months | Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome |
| Hospital admission | 6 months | Rate of hospital readmissions due to disease-related or procedure-related events in patients undergoing endoscopic therapy for pancreatic fluid collections. |
| Disease recurrence | 6 months | Rate of disease recurrence in patients undergoing endoscopic management of pancreatic fluid collections |
| Diabetes | 6 months | Rate of diabetes |
| Exocrine pancreatic insufficiency | 6 months | Rate of exocrine pancreatic insufficiency |
| Treatment costs | 6 months | Treatment costs from admission until hospital discharge |
Countries
United States
Contacts
CONTACTJi Young Bang
CONTACTBarbara J Broome
PRINCIPAL_INVESTIGATORJi Young Bang, MD MPH
Orlando Health, Digestive Health Institute
Outcome results
None listed