Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis

Patients will be randomly allocated to either treatment arm in a 1:1 ratio. Following intervention, patients will be assessed at regular intervals until study completion at 6 months post-discharge. Primary outcome is a composite of major complications and/or mortality, measured to 6 months post-discharge.

Inclusion criteria

• Necrotic collection

• Infected (suspected and confirmed): clinical signs of infection (septic, positive cultures, febrile), systemic inflammatory response syndrome, gas within the collection on imaging (not iatrogenic), or positive culture of collection contents
• Necrotic collection is within 15mm of the lumen of the gastrointestinal tract.
• 18 years and older
• Informed consent obtained from the patient or their medical representative.
• Medically fit for general anesthetic
• Collection amenable to either endoscopic or minimally invasive surgical necrosectomy and drainage.

Exclusion criteria

• <18 years old
• Unable to obtain informed consent from the patient or their medical representative.
• Medically unfit for general anesthesia
• Pregnant
• Necrotic collection not accessible by either or both techniques
• The collection is >15mm from the lumen of the gastrointestinal tract.
• Irreversible coagulopathy: International Normalized Ratio (INR) >1.5
• Irreversible thrombocytopenia: platelet count <50 x10^9/L
• Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
• Surgical or endoscopic necrosectomy or pseudocyst drainage has been performed within the preceding 12 months
• Necrotic collection secondary to trauma or other surgical event that requires additional interventions such as management of liver lacerations or vascular injury.
• Pre-existing percutaneous drain