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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03259880
• Other study ID #: assiut university 7001
• 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
• 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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

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