<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/NCT03780439</url>
  </required_header>
  <id_info>
    <org_study_id>PCT-INFECTION</org_study_id>
    <nct_id>NCT03780439</nct_id>
  </id_info>
  <brief_title>Procalcitonin to Predict Infection After Gastrectomy for Gastric Cancer</brief_title>
  <official_title>Diagnostic Accuracy of Procalcitonin as an Early Predictor of Infection After Radical Gastrectomy for Gastric Cancer: a Prospective Bi-center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yongchang Zhang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hunan Province Tumor Hospital</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>
      To investigate the diagnostic accuracy of procalcitonin as an early predictor of infection&#xD;
      after radical gastrectomy for gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From June 2018 to May 2019, consecutive eligible patients who underwent surgery for gastric&#xD;
      cancer in the Department of Gastroduodenal and Pancreatic Surgery, Hunan Cancer Hospital and&#xD;
      the treatment group of Professor Kai-xiong Tao in the Union Hospital of Tongji Medical&#xD;
      College were invited to participate in the study. After surgery, routine blood test were&#xD;
      measured morning on post-operative day (POD) 1, 3, 5, and 7, and serum level of procalcitonin&#xD;
      was measured morning on POD 3 and 5.&#xD;
&#xD;
      The primary outcome of the present study was the accuracy of white blood cell (WBC) and&#xD;
      neutrophil count, the neutrophil to WBC ratio (N%) and procalcitonin to detect post-operative&#xD;
      infection (including intra-abdominal infection (IAI), surgical site infections (SSIs),&#xD;
      pneumonia, urinary tract infection, catheter-related infection, and sepsis not specified)&#xD;
      within 30 days after surgery. The main secondary outcome was their ability to detect any&#xD;
      post-operative complications (such as intestinal obstruction, bleeding, ascites,&#xD;
      cardiovascular and cerebrovascular events) within 30 days after surgery. Other secondary&#xD;
      outcomes were the choice of the best timing to measure each inflammatory marker, the choice&#xD;
      of a clinically meaningful cut-off value for the most accurate marker.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">July 28, 2019</completion_date>
  <primary_completion_date type="Actual">July 28, 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>diagnostic accuracy of procalcitonin to detect post-operative infection</measure>
    <time_frame>within 30 days after surgery</time_frame>
    <description>the accuracy of procalcitonin to detect post-operative infection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>diagnostic accuracy of procalcitonin to detect overall post-operative complications</measure>
    <time_frame>within 30 days after surgery</time_frame>
    <description>the accuracy of procalcitonin to detect any post-operative complications</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">552</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>infection group and non-infection group</arm_group_label>
    <description>patients were divided into 2 sub-groups according to the presence of infection or not after radical gastrectomy for gastric cancer.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with pathologically diagnosed gastric adenocarcinoma who underwent radical&#xD;
        gastrectomy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥ 18 years&#xD;
&#xD;
          2. pathologically diagnosed gastric adenocarcinoma&#xD;
&#xD;
          3. radical gastrectomy with lymphadenectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ongoing infection at surgery&#xD;
&#xD;
          2. pregnancy status&#xD;
&#xD;
          3. underwent non-resection surgery&#xD;
&#xD;
          4. underwent palliative gastrectomy&#xD;
&#xD;
          5. emergency surgery&#xD;
&#xD;
          6. taking corticosteroid or other immunosuppressive drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hua Xiao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hunan Cancer Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hunan Province Tumor Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Facy O, Paquette B, Orry D, Binquet C, Masson D, Bouvier A, Fournel I, Charles PE, Rat P, Ortega-Deballon P; IMACORS Study. Diagnostic Accuracy of Inflammatory Markers As Early Predictors of Infection After Elective Colorectal Surgery: Results From the IMACORS Study. Ann Surg. 2016 May;263(5):961-6. doi: 10.1097/SLA.0000000000001303.</citation>
    <PMID>26135691</PMID>
  </results_reference>
  <results_reference>
    <citation>Cousin F, Ortega-Deballon P, Bourredjem A, Doussot A, Giaccaglia V, Fournel I. Diagnostic Accuracy of Procalcitonin and C-reactive Protein for the Early Diagnosis of Intra-abdominal Infection After Elective Colorectal Surgery: A Meta-analysis. Ann Surg. 2016 Aug;264(2):252-6. doi: 10.1097/SLA.0000000000001545.</citation>
    <PMID>27049766</PMID>
  </results_reference>
  <results_reference>
    <citation>Xiao H, Quan H, Pan S, Yin B, Luo W, Huang G, Ouyang Y. Impact of peri-operative blood transfusion on post-operative infections after radical gastrectomy for gastric cancer: a propensity score matching analysis focusing on the timing, amount of transfusion and role of leukocyte depletion. J Cancer Res Clin Oncol. 2018 Jun;144(6):1143-1154. doi: 10.1007/s00432-018-2630-8. Epub 2018 Mar 23.</citation>
    <PMID>29572591</PMID>
  </results_reference>
  <results_reference>
    <citation>Munoz JL, Ruiz-Tovar J, Miranda E, Berrio DL, Moya P, Gutierrez M, Flores R, Pico C, Perez A. C-Reactive Protein and Procalcitonin as Early Markers of Septic Complications after Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients Within an Enhanced Recovery After Surgery Program. J Am Coll Surg. 2016 May;222(5):831-7. doi: 10.1016/j.jamcollsurg.2016.01.059. Epub 2016 Feb 13.</citation>
    <PMID>27010585</PMID>
  </results_reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 15, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>September 22, 2019</last_update_submitted>
  <last_update_submitted_qc>September 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hunan Province Tumor Hospital</investigator_affiliation>
    <investigator_full_name>Yongchang Zhang</investigator_full_name>
    <investigator_title>Hunan Province Tumor Hospital</investigator_title>
  </responsible_party>
  <keyword>procalcitonin</keyword>
  <keyword>infection</keyword>
  <keyword>gastric cancer</keyword>
  <keyword>gastrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03780439
org study id: PCT-INFECTION
nct id: NCT03780439
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate the diagnostic accuracy of procalcitonin as an early predictor of infection
      after radical gastrectomy for gastric cancer.
From June 2018 to May 2019, consecutive eligible patients who underwent surgery for gastric
      cancer in the Department of Gastroduodenal and Pancreatic Surgery, Hunan Cancer Hospital and
      the treatment group of Professor Kai-xiong Tao in the Union Hospital of Tongji Medical
      College were invited to participate in the study. After surgery, routine blood test were
      measured morning on post-operative day (POD) 1, 3, 5, and 7, and serum level of procalcitonin
      was measured morning on POD 3 and 5.

      The primary outcome of the present study was the accuracy of white blood cell (WBC) and
      neutrophil count, the neutrophil to WBC ratio (N%) and procalcitonin to detect post-operative
      infection (including intra-abdominal infection (IAI), surgical site infections (SSIs),
      pneumonia, urinary tract infection, catheter-related infection, and sepsis not specified)
      within 30 days after surgery. The main secondary outcome was their ability to detect any
      post-operative complications (such as intestinal obstruction, bleeding, ascites,
      cardiovascular and cerebrovascular events) within 30 days after surgery. Other secondary
      outcomes were the choice of the best timing to measure each inflammatory marker, the choice
      of a clinically meaningful cut-off value for the most accurate marker.
observational model: Cohort
time perspective: Prospective
measure: diagnostic accuracy of procalcitonin to detect post-operative infection
time frame: within 30 days after surgery
description: the accuracy of procalcitonin to detect post-operative infection
measure: diagnostic accuracy of procalcitonin to detect overall post-operative complications
time frame: within 30 days after surgery
description: the accuracy of procalcitonin to detect any post-operative complications
arm group label: infection group and non-infection group
description: patients were divided into 2 sub-groups according to the presence of infection or not after radical gastrectomy for gastric cancer.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hua Xiao
role: Principal Investigator
affiliation: Hunan Cancer Hospital
facility: 
country: China
citation: Facy O, Paquette B, Orry D, Binquet C, Masson D, Bouvier A, Fournel I, Charles PE, Rat P, Ortega-Deballon P; IMACORS Study. Diagnostic Accuracy of Inflammatory Markers As Early Predictors of Infection After Elective Colorectal Surgery: Results From the IMACORS Study. Ann Surg. 2016 May;263(5):961-6. doi: 10.1097/SLA.0000000000001303.
PMID: 26135691
citation: Cousin F, Ortega-Deballon P, Bourredjem A, Doussot A, Giaccaglia V, Fournel I. Diagnostic Accuracy of Procalcitonin and C-reactive Protein for the Early Diagnosis of Intra-abdominal Infection After Elective Colorectal Surgery: A Meta-analysis. Ann Surg. 2016 Aug;264(2):252-6. doi: 10.1097/SLA.0000000000001545.
PMID: 27049766
citation: Xiao H, Quan H, Pan S, Yin B, Luo W, Huang G, Ouyang Y. Impact of peri-operative blood transfusion on post-operative infections after radical gastrectomy for gastric cancer: a propensity score matching analysis focusing on the timing, amount of transfusion and role of leukocyte depletion. J Cancer Res Clin Oncol. 2018 Jun;144(6):1143-1154. doi: 10.1007/s00432-018-2630-8. Epub 2018 Mar 23.
PMID: 29572591
citation: Munoz JL, Ruiz-Tovar J, Miranda E, Berrio DL, Moya P, Gutierrez M, Flores R, Pico C, Perez A. C-Reactive Protein and Procalcitonin as Early Markers of Septic Complications after Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients Within an Enhanced Recovery After Surgery Program. J Am Coll Surg. 2016 May;222(5):831-7. doi: 10.1016/j.jamcollsurg.2016.01.059. Epub 2016 Feb 13.
PMID: 27010585
responsible party type: Sponsor-Investigator
investigator affiliation: Hunan Province Tumor Hospital
investigator full name: Yongchang Zhang
investigator title: Hunan Province Tumor Hospital
mesh term: Infections
mesh term: Stomach Neoplasms
sharing ipd: No