<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/NCT03830060</url>
  </required_header>
  <id_info>
    <org_study_id>Pancreatitis</org_study_id>
    <nct_id>NCT03830060</nct_id>
  </id_info>
  <brief_title>Clinical Usefulness of Cortisol, Antinuclear Antibodies and High-sensitivity C-reactive Protein in Acute Pancreatitis</brief_title>
  <official_title>Clinical Usefulness of Cortisol, Antinuclear Antibodies and High-sensitivity C-reactive Protein in Diagnostic and Prognostic Evaluation of Acute Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <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 a potentially life-threatening disease with varying severity of&#xD;
      presentation. Nearly 60%-80% of all cases of AP in developed countries are attributable to&#xD;
      either gallstone disease or alcohol abuse. The incidence is similar in both sexes, although&#xD;
      alcohol abuse is the more common cause in men and gallstones is the more common cause in&#xD;
      women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Severe acute pancreatitis is one of the most common acute abdomens in clinical practice.&#xD;
      Owing to its acute onset, rapid progress, and high mortality, it has become a hot clinical&#xD;
      study spot and one of the toughest medical problems. Markers of inflammation, such as&#xD;
      high-sensitivity CRP (hs-CRP), are predictive of the severity of acute pancreatitis and may&#xD;
      be useful in identifying patients with severe acute pancreatitis in the early phase after&#xD;
      onset.&#xD;
&#xD;
      Antinuclear antibodies (ANA) are important biomarkers for the autoimmune disorder. ANA may&#xD;
      contribute to the pathogenesis of pancreatitis and ANA positivity is associated with the&#xD;
      presence of autoimmune pancreatitis. Cortisol is released into the blood due to stimulation&#xD;
      of corticotrophin receptors in the adrenal cortex. Thus, serum cortisol can be measured.&#xD;
      Although the association between serum levels of some inflammatory marker and acute&#xD;
      pancreatitis revealed, the relationship between ANA, cortisol, hs-CRP and with the severity&#xD;
      of acute pancreatic lesions have not evaluated yet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 25, 2019</start_date>
  <completion_date type="Anticipated">May 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 20, 2019</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>The mean difference of cortisol before and after treatment</measure>
    <time_frame>72 hours</time_frame>
    <description>Cortisol mean difference will be measured by immunofluorescence in acute pancreatitis.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Acute Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Group I:</arm_group_label>
    <description>Fifty AP patients on admission</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II:</arm_group_label>
    <description>The previous AP patients after 72 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Measurement of cortisol</intervention_name>
    <description>Cortisol will be measured by immunofluorescence and correlated with ANA and hs-CRP</description>
    <arm_group_label>Group I:</arm_group_label>
    <arm_group_label>Group II:</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Acute pancreatitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  abdominal pain consistent with AP&#xD;
&#xD;
          -  serum amylase activity at least 3 times greater than the upper limit of normal&#xD;
&#xD;
          -  Patients of age 18 years or more who are willing to participate in the study and give&#xD;
             their consent for same.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe liver disease, pulmonary embolus, sepsis, and renal failure were&#xD;
             excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>reham elmahdy</last_name>
    <phone>+201002714637</phone>
    <email>reham.elmahdy@aun.edu.eg</email>
  </overall_contact>
  <reference>
    <citation>Zhang XP, Zhang L, Wang Y, Cheng QH, Wang JM, Cai W, Shen HP, Cai J. Study of the protective effects of dexamethasone on multiple organ injury in rats with severe acute pancreatitis. JOP. 2007 Jul 9;8(4):400-12.</citation>
    <PMID>17625291</PMID>
  </reference>
  <reference>
    <citation>Imamura T, Tanaka S, Yoshida H, Kitamura K, Ikegami A, Takahashi A, Niikawa J, Mitamura K. Significance of measurement of high-sensitivity C-reactive protein in acute pancreatitis. J Gastroenterol. 2002;37(11):935-8. doi: 10.1007/s005350200157.</citation>
    <PMID>12483249</PMID>
  </reference>
  <reference>
    <citation>Nebiker CA, Staubli S, Schafer J, Bingisser R, Christ-Crain M, Dell-Kuster S, Mueller C, Scamardi K, Viehl CT, Kolleth D, von Holzen U, Oertli D, Rosenthal R. Cortisol Outperforms Novel Cardiovascular, Inflammatory, and Neurohumoral Biomarkers in the Prediction of Outcome in Acute Pancreatitis. Pancreas. 2018 Jan;47(1):55-64. doi: 10.1097/MPA.0000000000000962.</citation>
    <PMID>29215538</PMID>
  </reference>
  <reference>
    <citation>Smyk DS, Rigopoulou EI, Koutsoumpas AL, Kriese S, Burroughs AK, Bogdanos DP. Autoantibodies in autoimmune pancreatitis. Int J Rheumatol. 2012;2012:940831. doi: 10.1155/2012/940831. Epub 2012 Jul 12.</citation>
    <PMID>22844291</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 2, 2019</last_update_submitted>
  <last_update_submitted_qc>February 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Reham I El-mahdy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Marker of inflammation</keyword>
  <keyword>high-sensitivity CRP</keyword>
  <keyword>Antinuclear antibodies</keyword>
  <keyword>Cortisol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocortisone</mesh_term>
  </intervention_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/NCT03830060
org study id: Pancreatitis
nct id: NCT03830060
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Acute pancreatitis (AP) is a potentially life-threatening disease with varying severity of
      presentation. Nearly 60%-80% of all cases of AP in developed countries are attributable to
      either gallstone disease or alcohol abuse. The incidence is similar in both sexes, although
      alcohol abuse is the more common cause in men and gallstones is the more common cause in
      women.
Severe acute pancreatitis is one of the most common acute abdomens in clinical practice.
      Owing to its acute onset, rapid progress, and high mortality, it has become a hot clinical
      study spot and one of the toughest medical problems. Markers of inflammation, such as
      high-sensitivity CRP (hs-CRP), are predictive of the severity of acute pancreatitis and may
      be useful in identifying patients with severe acute pancreatitis in the early phase after
      onset.

      Antinuclear antibodies (ANA) are important biomarkers for the autoimmune disorder. ANA may
      contribute to the pathogenesis of pancreatitis and ANA positivity is associated with the
      presence of autoimmune pancreatitis. Cortisol is released into the blood due to stimulation
      of corticotrophin receptors in the adrenal cortex. Thus, serum cortisol can be measured.
      Although the association between serum levels of some inflammatory marker and acute
      pancreatitis revealed, the relationship between ANA, cortisol, hs-CRP and with the severity
      of acute pancreatic lesions have not evaluated yet.
observational model: Cohort
time perspective: Prospective
measure: The mean difference of cortisol before and after treatment
time frame: 72 hours
description: Cortisol mean difference will be measured by immunofluorescence in acute pancreatitis.
arm group label: Group I:
description: Fifty AP patients on admission
arm group label: Group II:
description: The previous AP patients after 72 hours
intervention type: Diagnostic Test
intervention name: Measurement of cortisol
description: Cortisol will be measured by immunofluorescence and correlated with ANA and hs-CRP
arm group label: Group I:
arm group label: Group II:
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: reham elmahdy
phone: +201002714637
email: reham.elmahdy@aun.edu.eg
citation: Zhang XP, Zhang L, Wang Y, Cheng QH, Wang JM, Cai W, Shen HP, Cai J. Study of the protective effects of dexamethasone on multiple organ injury in rats with severe acute pancreatitis. JOP. 2007 Jul 9;8(4):400-12.
PMID: 17625291
citation: Imamura T, Tanaka S, Yoshida H, Kitamura K, Ikegami A, Takahashi A, Niikawa J, Mitamura K. Significance of measurement of high-sensitivity C-reactive protein in acute pancreatitis. J Gastroenterol. 2002;37(11):935-8. doi: 10.1007/s005350200157.
PMID: 12483249
citation: Nebiker CA, Staubli S, Schafer J, Bingisser R, Christ-Crain M, Dell-Kuster S, Mueller C, Scamardi K, Viehl CT, Kolleth D, von Holzen U, Oertli D, Rosenthal R. Cortisol Outperforms Novel Cardiovascular, Inflammatory, and Neurohumoral Biomarkers in the Prediction of Outcome in Acute Pancreatitis. Pancreas. 2018 Jan;47(1):55-64. doi: 10.1097/MPA.0000000000000962.
PMID: 29215538
citation: Smyk DS, Rigopoulou EI, Koutsoumpas AL, Kriese S, Burroughs AK, Bogdanos DP. Autoantibodies in autoimmune pancreatitis. Int J Rheumatol. 2012;2012:940831. doi: 10.1155/2012/940831. Epub 2012 Jul 12.
PMID: 22844291
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Reham I El-mahdy
investigator title: Principal Investigator
mesh term: Pancreatitis
mesh term: Hypersensitivity
mesh term: Hydrocortisone