Geïnfecteerde necrotiserende pancreatitis Acute necrotizing pancreatitis severe acute pancreatitis
Conditions
Interventions
Immediate catheter drainage after diagnosing infected necrosis while starting
antibiotic treatment. If necessary necrosectomy will be performed and
postponed, if feasible, until the stage of walled-
catheter drainage will be
postponed under antibiotic treatment. If necessary necrosectomy will be
performed and postponed, if feasible, until the stage of walled-off necrosis.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Documented infected necrotizing pancreatitis - Suspected infected necrotizing pancreatitis (if > 14 days after onset of acute pancreatitis) - Catheter drainage of the collection with infected necrosis is technically feasible - Age >= 18 years
Exclusion criteria
Exclusion criteria: - > 35 days after onset of acute pancreatitis - Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding, bowel perforation, abdominal compartment syndrome) - Previous retroperitoneal intervention for necrotizing pancreatitis - Documented chronic pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome consists of the Comprehensive Complication Index (CCI), including all complications between randomization and 6 months after. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome are: mortality, new onset (multi) organ failure, bleeding requiring intervention, perforation requiring intervention, fistula, incisional hernia, wound infections, endocrine and exocrine pancreas insufficiency, number of patients with severe complications (Clavien-Dindo III or higher), number of patients per Clavien-Dindo classification, number of (re-)interventions, hospital and ICU length of stay, QALYs, (in)direct costs, and budget impact. | — |
Countries
Netherlands
Outcome results
None listed