Clinical trial NCT06179459: Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
Official title: Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Pancreatitis
Pancreatic Pseudocyst
Pancreatic Necrosis
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic fluid collections

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.
timeFrame: 3 years
Secondary outcomes:
measure: Treatment success
timeFrame: 6 months
measure: Number and type of interventions performed
timeFrame: 6 months
measure: Need for surgical intervention
timeFrame: 6 months
measure: Technical success of endoscopic interventions in pancreatic fluid collections.
timeFrame: 6 months
measure: Inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.
timeFrame: 6 months
measure: Disease-related adverse events
timeFrame: 6 monthts
measure: Procedure-related adverse events
timeFrame: 6 months
measure: Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome
timeFrame: 3 years
measure: Hospital admission
timeFrame: 6 months
measure: Disease recurrence
timeFrame: 3 years
measure: Diabetes
timeFrame: 3 years
measure: Exocrine pancreatic insufficiency
timeFrame: 3 years
measure: Timing of intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: Orlando Health, Digestive Health Institute
name: Ji Young Bang, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: