Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pancreatitis; Pancreatic Pseudocyst; Pancreatic Necrosis
• Intervention / Treatment: Procedure: Endoscopic management 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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Ji Young Bang; Phone Number: 321-841-2431; Email: jiyoung.bang@orlandohealth.com
• Study Contact Backup: Name: Barbara J Broome; Phone Number: 321-841-4356; Email: barbara.broome@orlandohealth.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 21806
      • Recruiting
      • Orlando Health
      • Contact: Ji Young Bang; Phone Number: 321-841-2431; Email: jiyoung.bang@orlandohealth.com
      • Contact: Barbara J Broome; Phone Number: 321-841-4356; Email: barbara.broome@orlandohealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with pancreatic fluid collections

Description

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 Plan

How is the study designed?

What is the study measuring?

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
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.	6 months

Collaborators and Investigators

• Sponsor: Orlando Health, Inc.
• Investigators: Principal Investigator: Ji Young Bang, MD MPH, Orlando Health, Digestive Health Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Cysts; Pancreatic Diseases; Pancreatic Cyst; Necrosis; Pancreatitis; Pancreatic Pseudocyst; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: 22.060.03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No