Acute necrotizing pancreatitis.
Conditions
Interventions
Patients will be randomly assigned to receive either endoscopic transmural debridement or standard conservative treatment.
Sponsors
Academic Medical Center (AMC), Department of Gastroenterology
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extent and duration of recovery measured by the Sickness Impact Profile (SIP) after 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactP. Fockens
Academic Medical Center (AMC) Department of Gastroenterology P.O. Box 22660
Outcome results
None listed