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

August 23, 2017 updated by: Fady Refaat Edwar Nasrallah

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

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Evaluation of the best prognostic parameter in patients with acute pancreatitis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year
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
one year
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

August 18, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 23, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • assiut university 7001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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