PancRea: Risk Factors and Outcomes of Infected Pancreatic Necrosis
NCT03253861
Acute Necrotizing Pancreatitis, Digestive System Diseases
Nantes, France
View Trial DetailsNCT Number: NCT03075605
This is a prospective case control study that compares the initial immune response with severity and outcome in patients with acute pancreatitis.
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All sexes
Observational
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
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.
Willingness to participate and sign informed consent
Exclusion criteria
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
Time frame: 1 year
To compare the initial immune response in patients who developed mild vs. severe disease. To determine whether functional polymorphisms in inflammation regulating genes predicts a more severe outcome in acute pancreatitis.
University of Pittsburgh
Other
Acronym: PROOF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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