Endoscopische verrichtingen Infected necrotizing pancreatitis
Conditions
Interventions
Endoscopic transluminale drainage with the Hot AXIOS stent.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - * 18 years old - Written informed consent - Walled-off pancreatic necrosis - Suspected or documented infected walled-off pancreatic necrosis - Endoscopic transluminal drainage is technically feasible as deemed by the Expert panel and/or treating physician.
Exclusion criteria
Exclusion criteria: - Previous invasive intervention for (peri)pancreatic necrosis and/or peripancreatic collections - Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding, bowel perforation, abdominal compartment syndrome) - Documented chronic pancreatitis according to the M-ANNHEIM criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the need for additional (endoscopic) necrosectomy to achieve clinical success. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Endoscopic morbidity (bleeding, perforation, stent migration or stent dysfunction) - Mortality - Pancreaticocutaneous fistula - Biliary stricture, requiring ERPC or PTC - New onset organ failure (cardiovascular, pulmonary, renal) - Additional radiological, endoscopic or surgical interventions - Number of endoscopic, radiological or surgical intervention - Total length of hospital stay - Exocrine and/or endocrine pancreatic insufficiency - Total length of Intensive care stay - Disease related death - Overall survival - Medical costs | — |
Countries
Netherlands
Outcome results
None listed