Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic management of pancreatic fluid collections.
- Who it may be relevant to
- Registry conditions: Acute Pancreatitis, Pancreatic Pseudocyst, Pancreatic Necrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Endoscopic management of pancreatic fluid collections
Patients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy
Primary outcome measures
- Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections according to timing of treatment. [Time frame: 6 months]
Secondary outcome measures (12)
- 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: 6 months]
- Hospital admission [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Orlando Health — Orlando
Identifiers
NCT: NCT06179459 · 22.060.03