Cooling the pancreas from the inside: a new device aims to tame severe inflammation

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Meets criteria for SIRS, defined as meeting two of the following four criteria, which need not be present simultaneously and may be demonstrated at any point during the screening-to-randomization window: * Temperature \>38°C (100.4°F) or \<36°C (96.8°F) * Heart rate \>90 beats per minute * Respiratory rate \>20 breaths per minute or PaCO2 \<32 mmHg * White blood cell (WBC) count \>12,000/mm³ or \<4,000/mm³, or \>10% immature (band) forms * Symptom onset within a window of time enabling ACC placement within a total of 48 hours * Diagnosis of acute pancreatitis by all three of the following criteria at the time of presentation (not referred), significant enough to require hospitalization: * Abdominal pain consistent with acute pancreatitis (acute onset of persistent, severe, epigastric pain, often radiating to the back) * Serum amylase and/or lipase greater than 3 times the upper limit of normal * Characteristic findings on contrast-enhanced CT (CECT). Note: If CT is not standard of care, it will be performed after the patient signs informed consent and all other eligibility criteria are met. * Signed written informed consent, and willingness and ability to complete follow-up requirements Exclusion Criteria: * Serum creatinine \>1.5 mg/dL or Glomerular filtration rate (GFR) \< 30 * Current treatment with pancreatic enzyme replacement therapy * Current treatment with hemodialysis or peritoneal dialysis * Treatment for all non-basal cell cancer within the last 1 year * Pancreatic calcifications identified by the baseline contrast-enhanced CT (CECT) * Receiving anti-coagulation or platelet count less than 50,000 * Known history of chronic pancreatitis * Surgery or endoscopic procedure for drainage or evidence of any pancreatic or gastrointestinal surgery (including gastric bypass) * Recurrent acute pancreatitis within 30 days * Suspected inability or contraindication to pass a naso-gastric catheter * Less than 40 kg of body mass * Known allergy to any device component (polyurethane, barium sulphate, polyvinyl chloride, polycarbonate, nylon, ABS, polyethylene) * Female who is pregnant * Participated in another investigational drug or therapeutic medical device study within 30 days before randomization * Any history of congestive heart failure * History of peptic ulcer disease and/or H. pylori within the past year * Body mass index ≥40 kg/m², or BMI ≥35 kg/m² with significant comorbidity, as determined at the investigator's discretion * Currently using GLP-1 receptor agonists (RAs)