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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03259880
Other study ID # assiut university 7001
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 18, 2017
Last updated August 23, 2017
Start date September 1, 2017
Est. completion date September 1, 2018

Study information

Verified date July 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date September 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Fady Refaat Edwar Nasrallah Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary evaluation of the prognostic value of neutrophil _lymphocyte ratio in cbc in patients with acute pancreatitis admitted at assiut university hospitals. evaluation of the prognostic value neutrophil lymphocyte ratio in patient with acute pancreatitis one year
Primary evaluation of the prognostic value of LDH in patients with acute pancreatitis admitted at assiut university hospitals. evaluation of the prognostic value of LDH ratio in patient with acute pancreatitis one year
Primary evaluation of the prognostic value of urine analysis in patients with acute pancreatitis admitted at assiut university hospitals. evaluation of the prognostic value of urine analysis ratio in patient with acute pancreatitis one year
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