Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOrlando Health, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
All patients undergoing endoscopic treatment of pancreatic fluid collections
Disqualifiers
Age < 18 years
Patients who did not receive endoscopic treatment of pancreatic fluid collections
Trial population
Patients with pancreatic fluid collections
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endoscopic management of pancreatic fluid collections
Procedure/SurgeryPatients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections according to timing of treatment.
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections is assessed as a composite measure consisting of 1) adverse events or 2) need for hospital admission due to underlying disease or procedure-related adverse events, in patients undergoing endoscopic treatment of pancreatic fluid collections, according to timing of treatment.
Time frame
6 monthsSecondary outcomes
1
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.
Time frame
6 months2
Number and type of interventions performed
Number of interventions performed to achieve treatment success
Time frame
6 months3
Need for surgical intervention
Need for any surgical intervention in patients undergoing endoscopic therapy for pancreatic fluid collections.
Time frame
6 months4
Technical success of endoscopic interventions in pancreatic fluid collections.
Technical success of endoscopic interventions in pancreatic fluid collections.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov