Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected pancreatic necrosis
Recruiting
- Conditions
- Infected necrotising pancreatitisMinimally invasiveEndoscopic drainageEndoscopic necrosectomyPercutaneous drainageSurgical necrosectomyGeinfecteerde necrotiserende pancreatitisMinimaal invasiefEndoscopische drainageEndoscopische necrosectomiePercutane drainagePercutane necrosectomie
- Registration Number
- NL-OMON28869
- Lead Sponsor
- Academic Medical Center, Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- 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 'step-up' approach as well as the surgical 'step-up' approach
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
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 requiring intervention, enterocutaneous fistula requiring intervention and incisional hernia (including burst abdomen).
- Secondary Outcome Measures
Name Time Method 1. Individual components of primary composite endpoint <br /><br>2. Other morbidity such as pancreaticocutaneous fistula <br /><br>3. Exocrine and/or endocrine pancreatic insufficiency <br /><br>4. Development of additional fluid collections requiring intervention <br /><br>5. Biliary strictures <br /><br>6. Wound infections <br /><br>7. The need for necrosectomy (either endoscopically or surgically) <br /><br>8. The total number of surgical, endoscopic or radiological (re-) interventions <br /><br>9. Total length of intensive care and hospital stay <br /><br>10. Quality of life <br /><br>11. Costs per patient with poor outcome <br /><br>12. Costs per quality adjusted life year (QALY) <br /><br>13. Total direct and indirect medical costs <br /><br>14. Total number of cross-overs between groups<br />