Minimally invasive step up approach versus maximal necrosectomy in patients with acute necrotising pancreatitis
- Conditions
- Infected necrotising pancreatitisDigestive SystemAcute pancreatitis
- Registration Number
- ISRCTN13975868
- Lead Sponsor
- niversity Medical Centre Utrecht (UMCU) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 94
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Hospital and intensive care stay <br>2. Total indirect and direct costs<br>3. Hospital stay after first intervention<br>4. Duration of intubation after first intervention <br>5. Quality of life