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Searching the Best Prognostic Factor in Out Come Evaluation in Patients With Acute Pancreatitis Admitted at Assiut University Hospitals

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ClinicalTrials.gov Identifier: NCT03259880
Recruitment Status : Not yet recruiting
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Collaborator:
Assiut University
Information provided by (Responsible Party):
Fady Refaat Edwar Nasrallah, Assiut University

Brief Summary:

Acute pancreatitis (AP) is rapid-onset inflammation of the pancreas that varies in severity from a self-limiting mild illness to rapidly progressive multiple organ failure. Statistics suggest that 10-20% of patients with AP develop severe AP (SAP),1 which usually has an unfavourable disease progression and is associated with a poor prognosis.

The two most common and important causes of acute pancreatitis are gallstones (40-70%) and alcohol (25-35%) Gallstone pancreatitis is usually due to an obstructing stone in the pancreatic duct near the sphincter of Oddi . In alcohol-related pancreatitis, it is believed that the acinar cells of the pancreas are susceptible to damage by ethanol and underlie the etiology of the disease . Another common cause, iatrogenic pancreatitis, may occur after endoscopic retrograde cholangiopancreatography (ERCP) in up to 5% of patients. Other etiologies of acute pancreatitis include medications, infections, trauma, hereditary, hypertriglyceridemia and autoimmune disease.


Condition or disease
Acute Pancreatitis

Detailed Description:

Acute pancreatitis (AP) is rapid-onset inflammation of the pancreas that varies in severity from a self-limiting mild illness to rapidly progressive multiple organ failure. Statistics suggest that 10-20% of patients with AP develop severe AP (SAP),1 which usually has an unfavourable disease progression and is associated with a poor prognosis. (Banks PA, Bollen,et al.).

The two most common and important causes of acute pancreatitis are gallstones (40-70%) and alcohol (25-35%) (Tenner S et al., 2014) Gallstone pancreatitis is usually due to an obstructing stone in the pancreatic duct near the sphincter of Oddi ( Bhatia M et al .,2005). In alcohol-related pancreatitis, it is believed that the acinar cells of the pancreas are susceptible to damage by ethanol and underlie the etiology of the disease ( Tonsi AF et al ., 2009). Another common cause, iatrogenic pancreatitis, may occur after endoscopic retrograde cholangiopancreatography (ERCP) in up to 5% of patients. Other etiologies of acute pancreatitis include medications, infections, trauma, hereditary, hypertriglyceridemia and autoimmune disease.

According to the American College of Gastroenterology, a patient must have two of the following three features present to make a diagnosis of acute pancreatitis The diagnostic criteria used for acute pancreatitis includes:

  1. Clinical criteria - history of pain in abdomen radiating to the back and relieved on bending forward associated with tenderness/guarding in the upper abdomen.
  2. Radiographic evidence - Computed Tomography findings suggestive of acute pancreatitis such as pancreatic edema, pancreatic necrosis, peripancreatic fluid collections
  3. Biochemical - Serum amylase concentration greater than 180 Somogyii units (by the Somogyii method).

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Searching the Best Best Prognostic Factor in Out Come Evaluation in Patients With Acute Pancreatitis Admitted at Assiut University Hospitals
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. evaluation of the prognostic value of neutrophil _lymphocyte ratio in cbc in patients with acute pancreatitis admitted at assiut university hospitals. [ Time Frame: one year ]
    evaluation of the prognostic value neutrophil lymphocyte ratio in patient with acute pancreatitis

  2. evaluation of the prognostic value of LDH in patients with acute pancreatitis admitted at assiut university hospitals. [ Time Frame: one year ]
    evaluation of the prognostic value of LDH ratio in patient with acute pancreatitis

  3. evaluation of the prognostic value of urine analysis in patients with acute pancreatitis admitted at assiut university hospitals. [ Time Frame: one year ]
    evaluation of the prognostic value of urine analysis ratio in patient with acute pancreatitis



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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Evaluation of the best prognostic parameter in patients with acute pancreatitis
Criteria

Inclusion Criteria:

  • 100 patients with acute pancreatitis admitted at Assiut university hospital and the diagnosis of acute pancreatitis is confirmed if at least two of the following three features present:

    1. abdominal pain characteristic of acute pancreatitis.
    2. serum amylase and/or lipase greater than 3 times the upper limit of normal .
    3. radiographically demonstrated acute pancreatitis on CT scan or abdominal ultrasound.

Exclusion Criteria:

  1. Patients are excluded from the study if they do not meet the criteria for acute pancreatitis
  2. Patients who are under the age of 16.
  3. Patients with chronic pancreatitis.
  4. Patients with recurrent acute pancreatitis

Responsible Party: Fady Refaat Edwar Nasrallah, internal medicine resident,Assiut University hospital, Assiut University
ClinicalTrials.gov Identifier: NCT03259880     History of Changes
Other Study ID Numbers: assiut university 7001
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fady Refaat Edwar Nasrallah, Assiut University:
evaluation

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases