Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

Recruiting

• Conditions: Pancreatic Pseudocyst; Acute Pancreatitis; Pancreatic Necrosis

• Registration Number: NCT06179459
• Lead Sponsor: Orlando Health, Inc.

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.

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31
• Primary Completion: 2032-12
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.	3 years	Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.

Secondary Outcome Measures

Name	Time	Method
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.
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
Disease recurrence	3 years	Rate of disease recurrence in patients undergoing endoscopic management of pancreatic fluid collections
Diabetes	3 years	Rate of diabetes
Number and type of interventions performed	6 months	Number of interventions performed to achieve treatment success
Technical success of endoscopic interventions in pancreatic fluid collections.	6 months	Technical success of endoscopic interventions in pancreatic fluid collections.
Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome	3 years	Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome
Exocrine pancreatic insufficiency	3 years	Rate of exocrine pancreatic insufficiency
Need for surgical intervention	6 months	Need for any surgical intervention in patients undergoing endoscopic therapy for pancreatic fluid collections.
Procedure-related adverse events	6 months	Procedure-related adverse events in patients undergoing endoscopic management of pancreatic fluid collection
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.
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.

Trial Locations

Locations (1)

Orlando Health; 🇺🇸 Orlando, Florida, United States