Standard CONservative approach versus endoscopic Debridement in patients with symptomatic sterile Organized pancReatic necrosis (CONDOR trial): a prospective randomised controlled trial.
- Conditions
- Acute necrotizing pancreatitis.
- Registration Number
- NL-OMON22846
- Lead Sponsor
- Academic Medical Center (AMC), Department of Gastroenterology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 58
1. Presence of a single (>6cm), large, well defined (peri)pancreatic fluid collection on contrast-enhanced computed tomography (CECT) or a similar fluid collection on MRI also containing necrotic material larger than 1 cm in diameter;
2. The presence of at least one of the following persistent symptoms, suspected to be caused by the fluid collection, despite of conservative treatment of minimally 6 weeks after onset of acute necrotizing pancreatitis:
1. Infected pancreatic necrosis, defined as the presence of air in the collection on CECT;
2. Suspected infected necrosis, defined as a rise of two out of three following parameters:>50% increase of leucocytes (minimal >15 10E9/L) or CRP (minimal >50 mg/L) or temperature rises above 38,5oC within 72 hours (with exclusion of other infectious causes);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Extent and duration of recovery measured by the Sickness Impact Profile (SIP) after 12 weeks.
- Secondary Outcome Measures
Name Time Method SIP scores after 26 and 52 weeks, total out of hospital days, resolution and recurrence of the pancreatic fluid collection, intervention-related complications, mortality, total number of interventions and (in)direct costs.