Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

Acute Pancreatitis Clinical Trial

Official title:

Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06179459
• Other study ID #: 22.060.03
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: December 2032

Study information

• Verified date: January 2024
• Source: Orlando Health, Inc.
• Contact: Ji Young Bang
• Phone: 321-841-2431
• Email: jiyoung.bang[@]orlandohealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2032
• Est. primary completion date: December 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Necrosis
• Pancreatic Necrosis
• Pancreatic Pseudocyst
• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

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

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Orlando Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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