PROOF: Pancreatitis-associated Risk Of Organ Failure

This is a prospective case control study that compares the initial immune response with
severity and outcome in patients with acute pancreatitis. Therefore, the investigators aim to
determine whether etiology of acute pancreatitis, segregates with candidate genetic
polymorphisms and their m-RNA expression, as well as whether functional polymorphisms in
inflammation regulating genes predict a more severe outcome in acute pancreatits. The
investigators anticipate that based on our results that we will provide a more accurate
predictor of the clinical course of acute pancreatits and help direct more aggressive or
cytokine specific treatment of patients at greater risk of a more severe form of the disease.

Inclusion Criteria:

- Inclusion criteria for Subjects (all three) Males and females of 16 years of age and
older. Body weight at least 40kg

Diagnosis of acute pancreatitis by both: Abdominal pain or abdominal localizing signs AND
Elevated amylase levels by at-least three times the upper limit of normal and/or elevated
lipase levels by at-least three times the upper limit of normal (25, 26). Acute
pancreatitis must be defined by 2 of the 3 following criteria:

- Serum amylase or lipase elevated greater than 3X upper limit of normal

- epigastric acute pancreatitis pain

- abdominal imaging studies demonstrating pancreatic edema, peripancreatic fat stranding
or complications or acute pancreatitis Willingness to participate in the study and
sign the informed consent. (Children and subjects who are cognitively impaired for
temporary reasons as mentioned in the section 4.7 of this protocol will require a
representative to sign the informed consent).

Inclusion criteria for Controls (all three) Males and females of 18 years of age and older.
a. Unrelated family member or a friend of the subject or a patient having blood drawn in
general medicine outpatient clinic, without a history of pancreatitis, OR Willingness to
participate in the study and sign the informed consent.

Additional Inclusion Criteria for subjects with a previous attack of acute pancreatitis:

age criteria as defined above.

- Previous severe attack of severe acute pancreatitis requiring a ICU stay of at least 48
hours or evidence of pancreatic necrosis on computerized tomography.

Willingness to participate and sign informed consent

Exclusion Criteria:

- Exclusion Criteria for Subjects:

Persons unwilling to sign the informed consent Disorientation secondary to irreversible
organic brain damage. Mean corpuscular volume (MCV) of less than 77 in all children of 18
years or younger.

Blood transfusion within one week of enrollment Chronic Pancreatitis History of pancreatic
cancer History of cancer requiring chemotherapy or radiation within the past 1 year History
of organ transplant Subject is a prisoner Pancreatitis due to multiple trauma or surgical
complications

Exclusion criteria for Controls:

Persons unwilling to sign the informed consent