Standard CONservative approach versus endoscopic Debridement in patients with symptomatic sterile Organized pancReatic necrosis (CONDOR trial): a prospective randomised controlled trial.

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:

a. Severe abdominal pain, defined as abdominal pain insufficiently relieved by non-narcotic analgesic (paracetamol (max 4000 mg/ day) and NSAIDS (equivalent to diclofenac (max 150 mg/day)) or requiring opiates;

b. Gastric outlet obstruction, defined as inability to tolerate oral solid intake or the need for gastro-jejeunal tube feeding;

c. Obstructive jaundice, dark urine, pale stools and serum total bilirubine values increased above 50 ìmol/l;

3. Fluid collection is in the immediate proximity of stomach and/or duodenum and seems to be accessible to endoscopic drainage based on the CT- or MRI-information;

4. Age equal to or above 18 years;

5. Written informed consent.

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);

3. New failure of at least one of the following organs: cardiac, pulmonary or renal;

4. Acute flare-up of chronic pancreatitis;

5. Previous endoscopic (transgastric or transduodenal), percutaneous or surgical drainage of a pancreatic fluid collection;

6. Unable to undergo upper gastrointestinal endoscopy.