<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/NCT04502940</url>
  </required_header>
  <id_info>
    <org_study_id>Pancreatitis 01.06.2020</org_study_id>
    <nct_id>NCT04502940</nct_id>
  </id_info>
  <brief_title>Is Lymphocyte Subtype Important for Acute Pancreatitis Severity?</brief_title>
  <official_title>Can we Measure Pancreatitis Severity With Flow Cytometry?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Pancreatitis is a common complication especially in patients with gallbladder stones, most&#xD;
      patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20%&#xD;
      of patients, the disease is severe and mortality rates of up to 30% are detected in these&#xD;
      patients. In the evaluation of acute biliary pancreatitis, many scoring systems have been&#xD;
      established (Atlanta, Ranson, APACHE, BISAP etc.) from past to present to determine morbidity&#xD;
      and mortality of the disease.&#xD;
&#xD;
      In this study, the investigators aimed to evaluate the correlation between morbidity and&#xD;
      mortality of acute biliary pancreatitis and lymphocyte subtypes with Flow-cytometry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreatitis is a common complication especially in patients with gallbladder stones, most&#xD;
      patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20%&#xD;
      of patients, the disease is severe and mortality rates of up to 30% are detected in these&#xD;
      patients. In patients with severe pancreatitis, aggressive fluid replacement, organ damage&#xD;
      follow-up, appropriate antibiotherapy, and endoscopic sphincterotomy and radiological&#xD;
      interventions may be of great benefit. In the evaluation of acute biliary pancreatitis, many&#xD;
      scoring systems have been established (Atlanta, Ranson, APACHE, BISAP etc.) from past to&#xD;
      present to determine morbidity and mortality of the disease. There are limited number of&#xD;
      studies in the literature about the immune parameters in the evaluation of acute&#xD;
      pancreatitis. In a studies, serum inflammatory markers such as IL-1, IL-6 and CD4, CD8 T&#xD;
      lymphocyte and Treg population were evaluated.Treg cells are reported to be an independent&#xD;
      prognostic factor in determining the severity of acute pancreatitis. In patients diagnosed&#xD;
      with acute biliary pancreatitis, determination of the course of the disease at the time of&#xD;
      diagnosis is extremely important for treatment and survival.&#xD;
&#xD;
      In this study, the investigators aimed to evaluate the correlation between morbidity and&#xD;
      mortality of acute biliary pancreatitis with lymphocyte subtypes via Flow-cytometry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">April 29, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Lymphocyte subtypes 1</measure>
    <time_frame>9 months</time_frame>
    <description>T helper (CD4) (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lymphocyte subtypes 2</measure>
    <time_frame>9 months</time_frame>
    <description>T cytotoxic (CD8) (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lymphocyte subtypes 3</measure>
    <time_frame>9 months</time_frame>
    <description>Treg (CD25 and CD127) (%)</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">53</enrollment>
  <condition>Pancreatitis</condition>
  <condition>Lymphocytic Infiltrate</condition>
  <condition>Immune System Diseases</condition>
  <arm_group>
    <arm_group_label>Mild pancreatitis</arm_group_label>
    <description>Patients with mild acute biliary pancreatitis according to Atlanta classification</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate Pancreatitis</arm_group_label>
    <description>Patients with moderate acute biliary pancreatitis according to Atlanta classification</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe pancreatitis</arm_group_label>
    <description>Patients with severe acute biliary pancreatitis according to Atlanta classification</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Healthy volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Flow Cytometric analysis</intervention_name>
    <description>Blood samples will be taken from the patients with biliary pancreatitis and healthy volunteers to perform flow-cytometric analysis and to determine lymphocyte subgroups</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Mild pancreatitis</arm_group_label>
    <arm_group_label>Moderate Pancreatitis</arm_group_label>
    <arm_group_label>Severe pancreatitis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute pancreatitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-80 years old&#xD;
&#xD;
          -  Diagnosis of acute biliary pancreatitis&#xD;
&#xD;
          -  Sign the voluntary consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being under 18 or older than 80&#xD;
&#xD;
          -  Not signing the voluntary consent form&#xD;
&#xD;
          -  Pancreatitis resulting from an interventional procedure (ERCP, surgery, etc.)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Being a history of immunodeficiency&#xD;
&#xD;
          -  Cancer history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oguzhagan Batikan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>İstanbul Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>İstanbul Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaziosmanpaşa Taksim Eğitim ve Araştırma Hastanesi</name>
      <address>
        <city>Istanbul</city>
        <zip>34900</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Wang W, Xiang HP, Wang HP, Zhu LX, Geng XP. CD4 + CD25 + CD127 high cells as a negative predictor of multiple organ failure in acute pancreatitis. World J Emerg Surg. 2017 Feb 2;12:7. doi: 10.1186/s13017-017-0116-7. eCollection 2017.</citation>
    <PMID>28174597</PMID>
  </reference>
  <reference>
    <citation>Yang Z, Zhang Y, Dong L, Yang C, Gou S, Yin T, Wu H, Wang C. The Reduction of Peripheral Blood CD4+ T Cell Indicates Persistent Organ Failure in Acute Pancreatitis. PLoS One. 2015 May 4;10(5):e0125529. doi: 10.1371/journal.pone.0125529. eCollection 2015.</citation>
    <PMID>25938229</PMID>
  </reference>
  <reference>
    <citation>Li J, Yang WJ, Huang LM, Tang CW. Immunomodulatory therapies for acute pancreatitis. World J Gastroenterol. 2014 Dec 7;20(45):16935-47. doi: 10.3748/wjg.v20.i45.16935.</citation>
    <PMID>25493006</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>April 30, 2021</last_update_submitted>
  <last_update_submitted_qc>April 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Oguzkagan Batikan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>pancreatitis</keyword>
  <keyword>lymphocyte</keyword>
  <keyword>Flow-cytometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Immune System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04502940
org study id: Pancreatitis 01.06.2020
nct id: NCT04502940
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Pancreatitis is a common complication especially in patients with gallbladder stones, most
      patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20%
      of patients, the disease is severe and mortality rates of up to 30% are detected in these
      patients. In the evaluation of acute biliary pancreatitis, many scoring systems have been
      established (Atlanta, Ranson, APACHE, BISAP etc.) from past to present to determine morbidity
      and mortality of the disease.

      In this study, the investigators aimed to evaluate the correlation between morbidity and
      mortality of acute biliary pancreatitis and lymphocyte subtypes with Flow-cytometry.
Pancreatitis is a common complication especially in patients with gallbladder stones, most
      patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20%
      of patients, the disease is severe and mortality rates of up to 30% are detected in these
      patients. In patients with severe pancreatitis, aggressive fluid replacement, organ damage
      follow-up, appropriate antibiotherapy, and endoscopic sphincterotomy and radiological
      interventions may be of great benefit. In the evaluation of acute biliary pancreatitis, many
      scoring systems have been established (Atlanta, Ranson, APACHE, BISAP etc.) from past to
      present to determine morbidity and mortality of the disease. There are limited number of
      studies in the literature about the immune parameters in the evaluation of acute
      pancreatitis. In a studies, serum inflammatory markers such as IL-1, IL-6 and CD4, CD8 T
      lymphocyte and Treg population were evaluated.Treg cells are reported to be an independent
      prognostic factor in determining the severity of acute pancreatitis. In patients diagnosed
      with acute biliary pancreatitis, determination of the course of the disease at the time of
      diagnosis is extremely important for treatment and survival.

      In this study, the investigators aimed to evaluate the correlation between morbidity and
      mortality of acute biliary pancreatitis with lymphocyte subtypes via Flow-cytometry.
observational model: Case-Control
time perspective: Prospective
measure: Lymphocyte subtypes 1
time frame: 9 months
description: T helper (CD4) (%)
measure: Lymphocyte subtypes 2
time frame: 9 months
description: T cytotoxic (CD8) (%)
measure: Lymphocyte subtypes 3
time frame: 9 months
description: Treg (CD25 and CD127) (%)
arm group label: Mild pancreatitis
description: Patients with mild acute biliary pancreatitis according to Atlanta classification
arm group label: Moderate Pancreatitis
description: Patients with moderate acute biliary pancreatitis according to Atlanta classification
arm group label: Severe pancreatitis
description: Patients with severe acute biliary pancreatitis according to Atlanta classification
arm group label: Control
description: Healthy volunteers
intervention type: Diagnostic Test
intervention name: Flow Cytometric analysis
description: Blood samples will be taken from the patients with biliary pancreatitis and healthy volunteers to perform flow-cytometric analysis and to determine lymphocyte subgroups
arm group label: Control
arm group label: Mild pancreatitis
arm group label: Moderate Pancreatitis
arm group label: Severe pancreatitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Oguzhagan Batikan, M.D.
role: Principal Investigator
affiliation: İstanbul Training and Research Hospital
facility: 
facility: 
country: Turkey
citation: Wang W, Xiang HP, Wang HP, Zhu LX, Geng XP. CD4 + CD25 + CD127 high cells as a negative predictor of multiple organ failure in acute pancreatitis. World J Emerg Surg. 2017 Feb 2;12:7. doi: 10.1186/s13017-017-0116-7. eCollection 2017.
PMID: 28174597
citation: Yang Z, Zhang Y, Dong L, Yang C, Gou S, Yin T, Wu H, Wang C. The Reduction of Peripheral Blood CD4+ T Cell Indicates Persistent Organ Failure in Acute Pancreatitis. PLoS One. 2015 May 4;10(5):e0125529. doi: 10.1371/journal.pone.0125529. eCollection 2015.
PMID: 25938229
citation: Li J, Yang WJ, Huang LM, Tang CW. Immunomodulatory therapies for acute pancreatitis. World J Gastroenterol. 2014 Dec 7;20(45):16935-47. doi: 10.3748/wjg.v20.i45.16935.
PMID: 25493006
responsible party type: Principal Investigator
investigator affiliation: Istanbul Training and Research Hospital
investigator full name: Oguzkagan Batikan
investigator title: Principal Investigator
mesh term: Pancreatitis
mesh term: Immune System Diseases
sharing ipd: Undecided