Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AdventHealth
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
\<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
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
Clareo Health | Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis
