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RecruitingObservational

Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections

NCT ID: NCT06179459Sponsor: Orlando Health, Inc.Last updated: 2025-11-04

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.

Arms & interventions

  • ProcedureEndoscopic management of pancreatic fluid collections

    Patients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy

Outcome measures

Primary

  • Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.

    Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.

    Time frame: 3 years

Secondary

  • Treatment success

    Time frame: 6 months

  • Number and type of interventions performed

    Time frame: 6 months

  • Need for surgical intervention

    Time frame: 6 months

  • Technical success of endoscopic interventions in pancreatic fluid collections.

    Time frame: 6 months

  • Inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.

    Time frame: 6 months

  • Disease-related adverse events

    Time frame: 6 monthts

  • Procedure-related adverse events

    Time frame: 6 months

  • Timing of intervention

    Time frame: 6 months

  • Hounsfield units of the pancreatic fluid collection

    Time frame: 6 months

  • Impact of partial versus full encapsulation of pancreatic fluid collections

    Time frame: 6 months

  • Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome

    Time frame: 3 years

  • Hospital admission

    Time frame: 6 months

  • Disease recurrence

    Time frame: 3 years

  • Diabetes

    Time frame: 3 years

  • Exocrine pancreatic insufficiency

    Time frame: 3 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Orlando Health

Orlando, Florida, 21806

Recruiting