ExTENSION. Long-term outcomes of a step-up endoscopic versus a surgical step-up approach in patients with infected pancreatic necrosis.
Recruiting
- Conditions
- Infected necrotizing pancreatitis
- Registration Number
- NL-OMON22403
- Lead Sponsor
- Amsterdam UMC – location AMC, Dutch pancreatitis study group (PWN)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
surviving patients of the TENSION trial who signed IFC
Exclusion Criteria
patients not willing to participate
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is composite of death and major complications, defined as new onset organ failure (cardiac, pulmonary or renal), incisional hernia, bleeding requiring intervention, perforation of a visceral organ requiring intervention or enterocutaneous fistula requiring intervention.
- Secondary Outcome Measures
Name Time Method The secondary clinical endpoints contain the separate individual components of the primary endpoint, pancreaticocutaneous fistula, recurrent pancreatitis, chronic pancreatitis according to the M-ANNHEIM diagnostic criteria, the need for additional catheter drainage or necrosectomy (either endoscopic or surgical), the total number of surgical, endoscopic or radiological (re-)interventions, biliary strictures, wound infections and exocrine and/or endocrine pancreatic insufficiency.