Infection of pancreas pancreatitis
Conditions
Interventions
Patients will be randomly assigned to receive either
endoscopic transgastric necrosectomy or necrosectomy by laparotomy and
continuous postoperative lavage.
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age equal to or above 18 years - Pancreatic necrosis or peripancreatic necrosis detected on CECT. - Patients in whom a decision for surgical intervention has been made because of (suspected) infected (peri-)pancreatic necrosis - Safe access route for endoscopic transgastric necrosectomy - Written informed consent
Exclusion criteria
Exclusion criteria: - Participation in another intervention trial that would interfere with the intervention and outcome of this study - Previous surgical necrosectomy for (suspected) infected pancreatic necrosis, Including procedures performed in referring hospitals. Previous percutaneous or transgastric drainage is allowed. - Previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy - Acute flare-up of chronic pancreatitis - Bleeding, abdominal compartment syndrome or perforation of a visceral organ as indication for intervention - Post-abdominal surgery necrotizing pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the total pro-inflammatory response as measured by the maximum increase in level of serum cytokine IL-6 in the period between start of the first necrosectomy and five hours thereafter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are complications (bleeding, perforation, pancreatic fistula, pancreatic pseudocyst requiring intervention, pancreatic abscess requiring intervention, biliary strictures, incisional hernia requiring re-intervention and pancreatic insufficiency) and mortality, total number of interventions, hospital and intensive care stay. | — |
Countries
Netherlands
Outcome results
None listed