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. Author manuscript; available in PMC: 2023 Jul 1.
Published in final edited form as: Pancreas. 2022 Jul 1;51(6):568–574. doi: 10.1097/MPA.0000000000002079

TABLE 2.

Exclusion Criteria for the Diabetes Related to Acute Pancreatitis and Its Mechanisms (DREAM) Study

  1. Diagnosis of definite CP at enrollment based on either of the following criteria met by CT scan (including non-contrast enhanced) or MRI with MRCP:
    • Parenchymal or ductal calcifications on CT scan (after excluding the possibility that calcifications are vascular)
    • Intraductal filling defects suggestive of calcifications on MRI and/or MRCP

  2. Potential participants with post-ERCP AP who are hospitalized for <48 hours.

  3. Prior (ie, before enrollment) direct endoscopic necrosectomy of the pancreas or percutaneous necrosectomy or drainage of necrotic collection(s). Participants who require this during follow-up will remain in the study.

  4. Pancreatic tumors, including ductal adenocarcinoma, neuroendocrine tumors, and metastasis.

  5. Confirmed or suspected cystic tumor associated with main pancreatic duct dilation or believed to be the cause of AP.

  6. Prior pancreatic surgery, including, but not limited to distal pancreatectomy, pancreaticoduodenectomy, pancreatic necrosectomy, Frey procedure.

  7. Use of disallowed concomitant medications within 30 days prior to enrollment. A comprehensive list of disallowed medications is listed and will be routinely updated in the study’s Manual of Procedures.

  8. Severe systemic illness that in the judgement of the investigative team will confound outcome assessments of DM and immunological outcomes or pose additional risk for harms, including: history of solid organ transplant, AIDS, active treatment for cancer (except non-melanoma skin cancer) within 12 months prior to enrollment, chronic kidney disease with eGFR <30 or on dialysis prior to AP, and cirrhosis (based on imaging or biopsy), or any other medical condition that in the opinion of the site-PI carries a life expectancy of <12 months.

  9. Known pregnancy at the time of enrollment. Participants who become pregnant during follow-up will remain in the study, but undergo modifications to study assessments for safety.

  10. Incarceration.

  11. Any other condition or factor that would compromise the participant’s safety or the scientific integrity of the study.

AIDS indicates acquired immunodeficiency syndrome; CP, chronic pancreatitis; CT, computed tomography; eGFR, estimated glomerular filtration rate; ERCP, endoscopic retrograde cholangiopancreatography; MRCP, magnetic resonance cholangiopancreatography; MRI, magnetic resonance imaging; PI, principal investigator