Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

Study Overview
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Brief Summary
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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
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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.

Official Title
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Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

Conditions
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Acute Pancreatitis, Pancreatic Pseudocyst, Pancreatic Necrosis

Intervention / Treatment
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* Procedure: Endoscopic management of pancreatic fluid collections


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic management of pancreatic fluid collections|Patients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections. | Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| Number and type of interventions performed | Number of interventions performed to achieve treatment success | 6 months | 
| Need for surgical intervention | Need for any surgical intervention in patients undergoing endoscopic therapy for pancreatic fluid collections. | 6 months | 
| Technical success of endoscopic interventions in pancreatic fluid collections. | Technical success of endoscopic interventions in pancreatic fluid collections. | 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. | 6 months | 
| Disease-related adverse events | Rate of disease-related adverse events | 6 monthts | 
| Procedure-related adverse events | Procedure-related adverse events in patients undergoing endoscopic management of pancreatic fluid collection | 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 | 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. | 6 months | 
| Disease recurrence | Rate of disease recurrence in patients undergoing endoscopic management of pancreatic fluid collections | 3 years | 
| Diabetes | Rate of diabetes | 3 years | 
| Exocrine pancreatic insufficiency | Rate of exocrine pancreatic insufficiency | 3 years |