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