The Evaluation of Pro/Antioxidative Profile and Diagnostic Parameters in the Patients With Pancreatic Disease

Study Overview
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Brief Summary
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The study aims to assess and analyze some selected antioxidants and laboratory parameters during hospitalization of the patients with acute pancreatitis. It will allow to better understanding of the mechanisms of disease and the development of better diagnostic, treatment and monitoring. It is an observational diagnostic study and does not involve any additional administration of medicinal substances, modification of treatment or dropping the use of routine methods of treatment of a disease. The study procedure includes detailed personal medical history as separate document like as a routine medical interview, and three times taking a small amount of venous blood (together about 15 ml), in the first, third, and seventh day of hospitalization (in the case of longer hospital treatment).

Official Title
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The Evaluation of Pro/Antioxidative Profile and Diagnostic Parameters in the Patients With Acute Pancreatitis

Conditions
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Acute Pancreatitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients were classified into the group of patients with acute pancreatitis (AP) due to clinical symptoms (acute onset of a persistent, severe, epigastric pain with tenderness on palpation on physical examination), personal interview and clinical method used in the diagnosis of pancreatitis - laboratory tests (elevation in serum lipase or amylase to three times or greater than the upper limit of normal) and characteristic findings of acute pancreatitis on imaging (contrast-enhanced computed tomography (CT), magnetic resonance imaging (MRI) or transabdominal ultrasonography). In patients with characteristic abdominal pain and elevation in serum lipase or amylase to three times or greater than the upper limit of normal, no imaging was required to establish the diagnosis of acute pancreatitis. In patients with abdominal pain that was not characteristic for acute pancreatitis or serum amylase or lipase levels that were less than three times the upper limit of normal, or in whom the diagnosis was uncertain, the investigators performed abdominal imaging with a contrast-enhanced abdominal CT scan to establish the diagnosis of acute pancreatitis and to exclude other causes of acute abdominal pain. In patients with severe contrast allergy or renal failure, the investigators performed an abdominal MRI without gadolinium. The volunteers classified as healthy based on the research conducted by clinicians of primary medical care (control group) Exclusion Criteria: other accompanied diseases than acute pancreatitis (the patients groups) Individuals of the control group with diagnosed disease as well as alcohol and drugs abusers
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Control group non-exposed to tobacco smoking | |
| 2<br>Control group exposed to tobacco smoking | |
| 3<br>Patients with acute pancreatitis non-exposed to tobacco smoking | |
| 4<br>Patients with acute pancreatitis exposed to tobacco smoking | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pro-inflammatory effect of tobacco smoke exposure measured by hsCRP concentration in the blood of patients with acute pancreatitis |  | 3 weeks | 
| Pro-inflammatory effect of tobacco smoke exposure measured by Interleukin-6 concentration in the blood of patients with acute pancreatitis |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The estimation of antioxidant status measured by the activities of antioxidant enzymes in the blood |  | 12 months | 
| The estimation of antioxidant status measured by small molecular antioxidants concentration in the blood |  | 3 months | 
| The estimation of prooxidant status measured by the concentration of lipids peroxidation products in the blood |  | 2 months | 
| The estimation of prooxidant status measured by the concentration of advanced oxidation protein products in the blood |  | 1 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoke, acute pancreatitis, pro/antioxidant status, pro-inflammatory factors, lipid profile, exocrine functions of pancreas