Infected necrotising pancreatitis Digestive System Acute pancreatitis
Conditions
Interventions
Minimally invasive step up approach: percutaneous catheter drainage, when necessary followed by minimally invasive surgical necrosectomy versus laparotomy and continuous postoperative lavage.
Sponsors
University Medical Centre Utrecht (UMCU) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of all Dutch University Medical Centers and 12 teaching hospitals who are diagnosed with (suspected) infected necrotising pancreatitis: 1. Aged equal to or above 18 years 2. Pancreatic necrosis or peripancreatic necrosis detected on CECT 3. Patients in whom a decision for surgical intervention has been made because of (suspected) infected (peri-)pancreatic necrosis 4. Possibility of placing a drain (either percutaneous or endoscopic) in the collection(s) 5. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Previous percutaneous drainage, endoscopic drainage or surgical necrosectomy for necrotising pancreatitis (endoscopic retrograde cholangio-pancreatography [ERCP] for biliary pancreatitis is allowed) 2. Acute attack in a patient with chronic pancreatitis 3. Participation in another intervention trial that would interfere with the intervention and outcome of this study 4. Acute primary intervention because of ?acute abdomen?, bleeding or perforation of a visceral organ 5. Post-operative (i.e. abdominal surgery) necrotising pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complications and mortality, expressed as the percentage of patients who died or had one or more of the complications listed in the protocol. Each complication will be assessed separately. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hospital and intensive care stay 2. Total indirect and direct costs 3. Hospital stay after first intervention 4. Duration of intubation after first intervention 5. Quality of life | — |
Countries
Netherlands
Outcome results
None listed