Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected pancreatic necrosis
Completed
- Conditions
- Infected necrotising pancreatitisDigestive SystemNecrotising pancreatitis
- Registration Number
- ISRCTN09186711
- Lead Sponsor
- Academic Medical Centre (AMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
1. Pancreatic necrosis and/or peripancreatic necrosis with (suspected or confirmed) infection
2. The peripancreatic collection is amenable to the endoscopic transluminal 'step-up' approach as well as the surgical 'step-up' approach
3. Aged greater than or equal to 18 years (either sex) and informed consent
Exclusion Criteria
1. Previous surgical, endoscopic or percutaneous intervention for pancreatic necrosis and/or peripancreatic necrosis and/or peripancreatic collections
2. Acute flare up of chronic pancreatitis
3. Concomitant indication for laparotomy because of suspected abdominal compartment syndrome, bleeding or perforation of a visceral organ
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of mortality and major morbidity. Major morbidity is defined as new onset organ failure (cardiac, pulmonary or renal), bleeding requiring intervention, perforation of a visceral organ (except for the stomach in ETN) requiring intervention, enterocutaneous fistula requiring intervention and incisional hernia (including burst abdomen). Measured at 6 months.
- Secondary Outcome Measures
Name Time Method Measured at 6 months:<br>1. Individual components of primary composite endpoint<br>2. Other morbidity such as pancreaticocutaneous fistula<br>3. Exocrine and/or endocrine pancreatic insufficiency<br>4. Development of additional fluid collections requiring intervention<br>5. Biliary strictures<br>6. Wound infections<br>7. The need for necrosectomy (either endoscopically or surgically)<br>8. The total number of surgical, endoscopic or radiological (re-) interventions<br>9. Total length of intensive care and hospital stay<br>10. Quality of life<br>11. Costs per patient with poor outcome<br>12. Costs per quality adjusted life year (QALY)<br>13. Total direct and indirect medical costs<br>14. Total number of cross-overs between groups