<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03259880</url>
  </required_header>
  <id_info>
    <org_study_id>assiut university 7001</org_study_id>
    <nct_id>NCT03259880</nct_id>
  </id_info>
  <brief_title>Searching the Best Prognostic Factor in Out Come Evaluation in Patients With Acute Pancreatitis Admitted at Assiut University Hospitals</brief_title>
  <official_title>Searching the Best Best Prognostic Factor in Out Come Evaluation in Patients With Acute Pancreatitis Admitted at Assiut University Hospitals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fady Refaat Edwar Nasrallah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute pancreatitis (AP) is rapid-onset inflammation of the pancreas that varies in severity&#xD;
      from a self-limiting mild illness to rapidly progressive multiple organ failure. Statistics&#xD;
      suggest that 10-20% of patients with AP develop severe AP (SAP),1 which usually has an&#xD;
      unfavourable disease progression and is associated with a poor prognosis.&#xD;
&#xD;
      The two most common and important causes of acute pancreatitis are gallstones (40-70%) and&#xD;
      alcohol (25-35%) Gallstone pancreatitis is usually due to an obstructing stone in the&#xD;
      pancreatic duct near the sphincter of Oddi . In alcohol-related pancreatitis, it is believed&#xD;
      that the acinar cells of the pancreas are susceptible to damage by ethanol and underlie the&#xD;
      etiology of the disease . Another common cause, iatrogenic pancreatitis, may occur after&#xD;
      endoscopic retrograde cholangiopancreatography (ERCP) in up to 5% of patients. Other&#xD;
      etiologies of acute pancreatitis include medications, infections, trauma, hereditary,&#xD;
      hypertriglyceridemia and autoimmune disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute pancreatitis (AP) is rapid-onset inflammation of the pancreas that varies in severity&#xD;
      from a self-limiting mild illness to rapidly progressive multiple organ failure. Statistics&#xD;
      suggest that 10-20% of patients with AP develop severe AP (SAP),1 which usually has an&#xD;
      unfavourable disease progression and is associated with a poor prognosis. (Banks PA,&#xD;
      Bollen,et al.).&#xD;
&#xD;
      The two most common and important causes of acute pancreatitis are gallstones (40-70%) and&#xD;
      alcohol (25-35%) (Tenner S et al., 2014) Gallstone pancreatitis is usually due to an&#xD;
      obstructing stone in the pancreatic duct near the sphincter of Oddi ( Bhatia M et al .,2005).&#xD;
      In alcohol-related pancreatitis, it is believed that the acinar cells of the pancreas are&#xD;
      susceptible to damage by ethanol and underlie the etiology of the disease ( Tonsi AF et al .,&#xD;
      2009). Another common cause, iatrogenic pancreatitis, may occur after endoscopic retrograde&#xD;
      cholangiopancreatography (ERCP) in up to 5% of patients. Other etiologies of acute&#xD;
      pancreatitis include medications, infections, trauma, hereditary, hypertriglyceridemia and&#xD;
      autoimmune disease.&#xD;
&#xD;
      According to the American College of Gastroenterology, a patient must have two of the&#xD;
      following three features present to make a diagnosis of acute pancreatitis The diagnostic&#xD;
      criteria used for acute pancreatitis includes:&#xD;
&#xD;
        1. Clinical criteria - history of pain in abdomen radiating to the back and relieved on&#xD;
           bending forward associated with tenderness/guarding in the upper abdomen.&#xD;
&#xD;
        2. Radiographic evidence - Computed Tomography findings suggestive of acute pancreatitis&#xD;
           such as pancreatic edema, pancreatic necrosis, peripancreatic fluid collections&#xD;
&#xD;
        3. Biochemical - Serum amylase concentration greater than 180 Somogyii units (by the&#xD;
           Somogyii method).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>evaluation of the prognostic value of neutrophil _lymphocyte ratio in cbc in patients with acute pancreatitis admitted at assiut university hospitals.</measure>
    <time_frame>one year</time_frame>
    <description>evaluation of the prognostic value neutrophil lymphocyte ratio in patient with acute pancreatitis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>evaluation of the prognostic value of LDH in patients with acute pancreatitis admitted at assiut university hospitals.</measure>
    <time_frame>one year</time_frame>
    <description>evaluation of the prognostic value of LDH ratio in patient with acute pancreatitis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>evaluation of the prognostic value of urine analysis in patients with acute pancreatitis admitted at assiut university hospitals.</measure>
    <time_frame>one year</time_frame>
    <description>evaluation of the prognostic value of urine analysis ratio in patient with acute pancreatitis</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Acute Pancreatitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Evaluation of the best prognostic parameter in patients with acute pancreatitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  100 patients with acute pancreatitis admitted at Assiut university hospital and the&#xD;
             diagnosis of acute pancreatitis is confirmed if at least two of the following three&#xD;
             features present:&#xD;
&#xD;
               1. abdominal pain characteristic of acute pancreatitis.&#xD;
&#xD;
               2. serum amylase and/or lipase greater than 3 times the upper limit of normal .&#xD;
&#xD;
               3. radiographically demonstrated acute pancreatitis on CT scan or abdominal&#xD;
                  ultrasound.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients are excluded from the study if they do not meet the criteria for acute&#xD;
             pancreatitis&#xD;
&#xD;
          2. Patients who are under the age of 16.&#xD;
&#xD;
          3. Patients with chronic pancreatitis.&#xD;
&#xD;
          4. Patients with recurrent acute pancreatitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Fady Refaat Edwar Nasrallah</investigator_full_name>
    <investigator_title>internal medicine resident,Assiut University hospital</investigator_title>
  </responsible_party>
  <keyword>evaluation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03259880
org study id: assiut university 7001
nct id: NCT03259880
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
observational model: Cohort
time perspective: Prospective
measure: 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
description: evaluation of the prognostic value neutrophil lymphocyte ratio in patient with acute pancreatitis
measure: evaluation of the prognostic value of LDH in patients with acute pancreatitis admitted at assiut university hospitals.
time frame: one year
description: evaluation of the prognostic value of LDH ratio in patient with acute pancreatitis
measure: evaluation of the prognostic value of urine analysis in patients with acute pancreatitis admitted at assiut university hospitals.
time frame: one year
description: evaluation of the prognostic value of urine analysis ratio in patient with acute pancreatitis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Fady Refaat Edwar Nasrallah
investigator title: internal medicine resident,Assiut University hospital
mesh term: Pancreatitis