<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/NCT01704664</url>
  </required_header>
  <id_info>
    <org_study_id>3-37878 L</org_study_id>
    <nct_id>NCT01704664</nct_id>
  </id_info>
  <brief_title>Perioperative Immunonutrition, Phagocytic and Bactericidal Activity of Blood Platelets in Gastric Cancer Patients</brief_title>
  <official_title>Prospective Study of the Effect of Perioperative Immunonutrition on the Immune Host Defense and the Phagocytic and Bactericidal Activity of Blood Platelets in Gastric Cancer Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Bialystok</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Bialystok</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Perioperative immunonutrition in gastric cancer patients can reduce perioperative morbidity&#xD;
      and may improve quality of their life. Patients with gastric cancer will be divided into four&#xD;
      groups depending on the type of artificial nutrition. Group I (enteral feeding) and II&#xD;
      (enteral feeding and parenteral nutrition with glutamine) will be administered nutritional&#xD;
      therapy during the postoperative period, group III (oral arginine) and IV (parenteral&#xD;
      immunonutrition) patients will be treated nutritionally both prior to and after the surgery.&#xD;
      The lymphocytes and their subpopulations, interleukin IL-1B,-6,-23, and the phagocytic, and&#xD;
      bactericidal activity of blood platelets will be determined before and after nutritional&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical treatment of gastric cancer is associated with a high risk of perioperative&#xD;
      complications. Morbidity of cancer patients increases in concert with the clinical stage of&#xD;
      the malignancy. It is postulated that a reduction in perioperative morbidity and improved&#xD;
      quality of life of patients with advanced gastric cancer can be achieved by proper&#xD;
      preparation to surgery, among others. One of such methods is the implementation of&#xD;
      immunostimulating nutritional therapy during the perioperative period.The stage of cancer&#xD;
      will be graded according to TNM classification. The patients will be randomly assigned to&#xD;
      four clinical groups based on the type of nutritional therapy implemented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2007</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phagocytic activity of blood platelets in gastric cancer patients.</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 3 weeks</time_frame>
    <description>Platelet count and phagocytic activity of thrombocytes will be examined twice in each patient. Blood samples for laboratory tests will be drawn prior to surgery and nutritional therapy and 12 days after the surgery. Thrombocyte count will be determined using ADVIA 120 haematological analyser. Phagocytic activity of blood platelets will be determined against Staphylococcus aureus ATCC 6538P bacterial strain. It expresses as the fraction of phagocytizing platelets and the phagocytic index. The fraction of phagocytizing platelets corresponds to the percentage of phagocyting thrombocytes per 1000 consecutive cells of this type. The phagocytic index represents the ratio of phagocytized bacteria per 100 phagocytic platelets.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>I - Nutritional therapy only during the postoperative period.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Postoperative nutritional therapy administered in group I will not include immunomodulating factors. Early postoperative enteral nutrition, based on standard elementary diet (Peptisorb), starts 20 hours post-surgery. The initial flow rate will be 8 ml/h, which will be increased gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition will be continued for six days. During the initial five days post-surgery, the patients will be additionally supplemented parenterally via peripheral veins (commercially available two-chamber bag for peripheral access with 480 kcal of energetic value and 5.7g of N contained in standard amino acids).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>II - parenteral glutamine in postoperative time</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The nutritional therapy of group II patients will start post-surgery. It will be based on early enteral nutrition with elementary diet (Peptisorb) with simultaneous parenteral nutrition with two-chamber bag with 480 kcal energetic value and 5.7g of N contained in standard amino acids administered via peripheral veins. Additionally, glutamine (100 ml of Dipeptiven) will be added to the two-chamber bag. The parenteral nutrition will be administered for five days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>III - perioperative oral immunonutrition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preoperatively, group III patients will be given commercially available oral diet enriched with arginine (Cubitan, 1 package 3 times per day). Additionally, they will be administered commercially available two-chamber bag with 480 kcal energetic value and 5.7g of N in standard amino acids via peripheral access. The duration of pre-operative preparatory phase ranged between 5 and 10 days (8 days on average). Enteral nutrition with commercially available arginine-containing diet (Cubison) will start 20 hours post-surgery at an 8 ml/h flow rate; the rate will be increased gradually, with the volume doubled every 24 hours, up to 100 ml/h and continued for six days. Simultaneously, commercially available two-chamber bags for peripheral access with composition identical to that used preoperatively will be administered via peripheral veins for five days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IV - Perioperative parenteral immunonutrition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nutritional therapy of group IV will be based on intravenous preparations. Two-chamber bags with 480 kcal energetic value and 5.7 g of N in standard amino acids will be administered preoperatively. A solution of glutamine (Dipeptiven, 100 ml) and ω3-fatty acids (Omegaven, 100 ml) will be added to the bags. The duration of pre-operative preparatory phase ranged between 5 and 10 days (8 days on average). Enteral nutrition with elementary commercially available diet (Peptisorb) will be begun 20 hours post-surgery; it will be started at an 8 ml/h flow rate and increased gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition will be continued for six days. During the initial five days post-surgery, the patients will be additionally supplemented parenterally via peripheral veins; similarly to the preoperative period, the content of two-chamber bag for peripheral access enriched with glutamine and ω3-fatty acids will be administered for five days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Early postoperative enteral nutrition, based on standard elementary diet (Peptisorb)</intervention_name>
    <description>Early postoperative enteral nutrition with standard elementary diet (Peptisorb), will start 20 hours post-surgery. The initial flow rate will be 8 ml/h, which will increase gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition wil be continued for six days. During the initial five days post-surgery, the patients will be additionally supplemented parenterally via peripheral veins (commercially available two-chamber bag for peripheral access with 480 kcal of energetic value and 5.7g of N contained in standard amino acids).</description>
    <arm_group_label>I - Nutritional therapy only during the postoperative period.</arm_group_label>
    <arm_group_label>II - parenteral glutamine in postoperative time</arm_group_label>
    <arm_group_label>IV - Perioperative parenteral immunonutrition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>glutamine</intervention_name>
    <description>The nutritional therapy of group II patients will start post-surgery. It will be based on early enteral nutrition with elementary diet (Peptisorb) with simultaneous parenteral nutrition with two-chamber bag with 480 kcal energetic value and 5.7g of N contained in standard amino acids administered via peripheral veins. Additionally, glutamine (100 ml of Dipeptiven) will be added to the two-chamber bag. The parenteral nutrition will be administered for five days.</description>
    <arm_group_label>II - parenteral glutamine in postoperative time</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>oral diet enriched with arginine (Cubitan)</intervention_name>
    <description>Preoperatively, group III patients will be given commercially available oral diet enriched with arginine (Cubitan, 1 package 3 times per day). Additionally, they were administered commercially available two-chamber bag with 480 kcal energetic value and 5.7g of N in standard amino acids via peripheral access. The duration of pre-operative preparatory phase ranged between 5 and 10 days (8 days on average). Enteral nutrition with commercially available arginine-containing diet (Cubison) will start 20 hours post-surgery at an 8 ml/h flow rate; the rate will increase gradually, with the volume doubled every 24 hours, up to 100 ml/h and continued for six days. Simultaneously, commercially available two-chamber bags for peripheral access with composition identical to that used preoperatively will be administered via peripheral veins for five days.</description>
    <arm_group_label>III - perioperative oral immunonutrition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perioperative parenteral immunonutrition (Dipeptiven, Omegaven)</intervention_name>
    <description>Nutritional therapy of group IV will based on intravenous preparations. Two-chamber bags with 480 kcal energetic value and 5.7 g of N in standard amino acids were administered preoperatively. A solution of glutamine (Dipeptiven, 100 ml) and ω3-fatty acids (Omegaven, 100 ml) will be added to the bags. The duration of pre-operative preparatory phase ranged between 5 and 10 days (8 days on average). Enteral nutrition with elementary commercially available diet (Peptisorb) will be begun 20 hours post-surgery; it will start at an 8 ml/h flow rate and increased gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition was continued for six days. During the initial five days post-surgery, the patients will be additionally supplemented parenterally via peripheral veins; similarly to the preoperative period, the content of two-chamber bag for peripheral access enriched with glutamine and ω3-fatty acids will be administered for five days.</description>
    <arm_group_label>IV - Perioperative parenteral immunonutrition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  gastric cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  for group III constituted gastric cancer associated with severe gastrointestinal&#xD;
             obstruction&#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>Zbigniew Kamocki, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>2nd Department of General and Gastroenterological Surgery Medical University of Bialystok</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zbigniew Kamocki, MD PhD</last_name>
    <phone>+48606452246</phone>
    <email>zkamocki@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical University of Bialystok</name>
      <address>
        <city>Bialystok</city>
        <state>Podlaskie</state>
        <zip>15089</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zbigniew Kamocki, MD PhD</last_name>
      <phone>+48606452246</phone>
      <email>zkamocki@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Zbigniew Kamocki, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joanna Matowicka-Karna, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joanna Osada, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <results_reference>
    <citation>Noisakran S, Gibbons RV, Songprakhon P, Jairungsri A, Ajariyakhajorn Ch, Nisalak A, Jarman RG, Malasit P, Chokephaibulkit K, Perng GC. Detection of dengue virus in platelets isolated from dengue patients. Southeast Asian J Trop Med Public Health. 2009; 40: 253-262. Mustard JF, Packham MA. Platelet phagocytosis. Sem Haematol 1968; 2: 168-184. Clawson CC, White JG.: Platelet interaction with bacteria. I Reaction phases and effects on inhibitors. Am I Pathol 1971; 65: 367-380. Kemona H, Andrzejewska A, Prokopowicz J, Nowak H, Mantur M. Phagocytic activity of human blood platelets examined by electron microscopy. Folia Haematol Int Mag Klin Morphol Blutforsch 1986; 113: 696-702. Bessler H, Agam G, Diadetti M. Increased protein synthesis by human platelets during phagocytosis of latex particles in vivo. Thromb Diath Haemorrh 1976; 35: 350-357. Tang YQ, Yeaman MR, Selsted ME. Antimicrobial peptides from human platelets. Infect Immun 2002; 70: 6524-6533. Yeaman MR. The role of platelets in antimicrobial host defense. Clin Infect Dis 1997; 5: 951-968. Page CP. Platelets as inflammatory cells. Immunopharmacology 1989; 17: 51-59. Sun B, Li J, Kambayashi J. Interaction between GPIbalpha and FcgammaIIa receptor in human platelets. Biochem Biophys Res Commun 1999; 266: 24-27. Kemona H, Andrzejewska A, Prokopowicz J, Nowak H, Mantur M. Phagocytic activity of human blood platelets examined by electron microscopy. Folia Haematol 1986; 113: 696-702. Nash GF, Turner LF, Scully MF, Kakkar AK. Platelets and cancer. Lancet Oncol 2002; 3: 425-430. Yu Y, Zhou XD, Liu YK, Ren N, Chen J. Platelets promote the adhesion of human hepatoma cells with highly metastatic potential to extracellular matrix protein: involvement of platelets P-selectin and GP IIb-IIIa. J Cancer Res Clin Oncol 2002; 128: 283-287. Kamocki Z, Matowicka-Karna J, Piotrowski Z, Kemona H. Bacteriocidal capacity of platelets in gastric cancer patients. Neoplasma 2004; 51: 265-268</citation>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>malnutrition,</keyword>
  <keyword>perioperative artificial nutrition,</keyword>
  <keyword>immunonutrition,</keyword>
  <keyword>gastrectomy,</keyword>
  <keyword>lymphocytes,</keyword>
  <keyword>interleukin,</keyword>
  <keyword>blood platelets,</keyword>
  <keyword>phagocytic and bactericidal activity of blood platelets</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</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/NCT01704664
org study id: 3-37878 L
nct id: NCT01704664
lead sponsor: 
has dmc: Yes
Perioperative immunonutrition in gastric cancer patients can reduce perioperative morbidity
      and may improve quality of their life. Patients with gastric cancer will be divided into four
      groups depending on the type of artificial nutrition. Group I (enteral feeding) and II
      (enteral feeding and parenteral nutrition with glutamine) will be administered nutritional
      therapy during the postoperative period, group III (oral arginine) and IV (parenteral
      immunonutrition) patients will be treated nutritionally both prior to and after the surgery.
      The lymphocytes and their subpopulations, interleukin IL-1B,-6,-23, and the phagocytic, and
      bactericidal activity of blood platelets will be determined before and after nutritional
      therapy.
Surgical treatment of gastric cancer is associated with a high risk of perioperative
      complications. Morbidity of cancer patients increases in concert with the clinical stage of
      the malignancy. It is postulated that a reduction in perioperative morbidity and improved
      quality of life of patients with advanced gastric cancer can be achieved by proper
      preparation to surgery, among others. One of such methods is the implementation of
      immunostimulating nutritional therapy during the perioperative period.The stage of cancer
      will be graded according to TNM classification. The patients will be randomly assigned to
      four clinical groups based on the type of nutritional therapy implemented.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Phagocytic activity of blood platelets in gastric cancer patients.
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
description: Platelet count and phagocytic activity of thrombocytes will be examined twice in each patient. Blood samples for laboratory tests will be drawn prior to surgery and nutritional therapy and 12 days after the surgery. Thrombocyte count will be determined using ADVIA 120 haematological analyser. Phagocytic activity of blood platelets will be determined against Staphylococcus aureus ATCC 6538P bacterial strain. It expresses as the fraction of phagocytizing platelets and the phagocytic index. The fraction of phagocytizing platelets corresponds to the percentage of phagocyting thrombocytes per 1000 consecutive cells of this type. The phagocytic index represents the ratio of phagocytized bacteria per 100 phagocytic platelets.
arm group label: I - Nutritional therapy only during the postoperative period.
arm group type: Active Comparator
description: Postoperative nutritional therapy administered in group I will not include immunomodulating factors. Early postoperative enteral nutrition, based on standard elementary diet (Peptisorb), starts 20 hours post-surgery. The initial flow rate will be 8 ml/h, which will be increased gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition will be continued for six days. During the initial five days post-surgery, the patients will be additionally supplemented parenterally via peripheral veins (commercially available two-chamber bag for peripheral access with 480 kcal of energetic value and 5.7g of N contained in standard amino acids).
arm group label: II - parenteral glutamine in postoperative time
arm group type: Active Comparator
description: The nutritional therapy of group II patients will start post-surgery. It will be based on early enteral nutrition with elementary diet (Peptisorb) with simultaneous parenteral nutrition with two-chamber bag with 480 kcal energetic value and 5.7g of N contained in standard amino acids administered via peripheral veins. Additionally, glutamine (100 ml of Dipeptiven) will be added to the two-chamber bag. The parenteral nutrition will be administered for five days.
arm group label: III - perioperative oral immunonutrition
arm group type: Active Comparator
description: Preoperatively, group III patients will be given commercially available oral diet enriched with arginine (Cubitan, 1 package 3 times per day). Additionally, they will be administered commercially available two-chamber bag with 480 kcal energetic value and 5.7g of N in standard amino acids via peripheral access. The duration of pre-operative preparatory phase ranged between 5 and 10 days (8 days on average). Enteral nutrition with commercially available arginine-containing diet (Cubison) will start 20 hours post-surgery at an 8 ml/h flow rate; the rate will be increased gradually, with the volume doubled every 24 hours, up to 100 ml/h and continued for six days. Simultaneously, commercially available two-chamber bags for peripheral access with composition identical to that used preoperatively will be administered via peripheral veins for five days.
arm group label: IV - Perioperative parenteral immunonutrition
arm group type: Active Comparator
description: Nutritional therapy of group IV will be based on intravenous preparations. Two-chamber bags with 480 kcal energetic value and 5.7 g of N in standard amino acids will be administered preoperatively. A solution of glutamine (Dipeptiven, 100 ml) and ω3-fatty acids (Omegaven, 100 ml) will be added to the bags. The duration of pre-operative preparatory phase ranged between 5 and 10 days (8 days on average). Enteral nutrition with elementary commercially available diet (Peptisorb) will be begun 20 hours post-surgery; it will be started at an 8 ml/h flow rate and increased gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition will be continued for six days. During the initial five days post-surgery, the patients will be additionally supplemented parenterally via peripheral veins; similarly to the preoperative period, the content of two-chamber bag for peripheral access enriched with glutamine and ω3-fatty acids will be administered for five days.
intervention type: Dietary Supplement
intervention name: Early postoperative enteral nutrition, based on standard elementary diet (Peptisorb)
description: Early postoperative enteral nutrition with standard elementary diet (Peptisorb), will start 20 hours post-surgery. The initial flow rate will be 8 ml/h, which will increase gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition wil be continued for six days. During the initial five days post-surgery, the patients will be additionally supplemented parenterally via peripheral veins (commercially available two-chamber bag for peripheral access with 480 kcal of energetic value and 5.7g of N contained in standard amino acids).
arm group label: I - Nutritional therapy only during the postoperative period.
arm group label: II - parenteral glutamine in postoperative time
arm group label: IV - Perioperative parenteral immunonutrition
intervention type: Drug
intervention name: glutamine
description: The nutritional therapy of group II patients will start post-surgery. It will be based on early enteral nutrition with elementary diet (Peptisorb) with simultaneous parenteral nutrition with two-chamber bag with 480 kcal energetic value and 5.7g of N contained in standard amino acids administered via peripheral veins. Additionally, glutamine (100 ml of Dipeptiven) will be added to the two-chamber bag. The parenteral nutrition will be administered for five days.
arm group label: II - parenteral glutamine in postoperative time
intervention type: Dietary Supplement
intervention name: oral diet enriched with arginine (Cubitan)
description: Preoperatively, group III patients will be given commercially available oral diet enriched with arginine (Cubitan, 1 package 3 times per day). Additionally, they were administered commercially available two-chamber bag with 480 kcal energetic value and 5.7g of N in standard amino acids via peripheral access. The duration of pre-operative preparatory phase ranged between 5 and 10 days (8 days on average). Enteral nutrition with commercially available arginine-containing diet (Cubison) will start 20 hours post-surgery at an 8 ml/h flow rate; the rate will increase gradually, with the volume doubled every 24 hours, up to 100 ml/h and continued for six days. Simultaneously, commercially available two-chamber bags for peripheral access with composition identical to that used preoperatively will be administered via peripheral veins for five days.
arm group label: III - perioperative oral immunonutrition
intervention type: Drug
intervention name: Perioperative parenteral immunonutrition (Dipeptiven, Omegaven)
description: Nutritional therapy of group IV will based on intravenous preparations. Two-chamber bags with 480 kcal energetic value and 5.7 g of N in standard amino acids were administered preoperatively. A solution of glutamine (Dipeptiven, 100 ml) and ω3-fatty acids (Omegaven, 100 ml) will be added to the bags. The duration of pre-operative preparatory phase ranged between 5 and 10 days (8 days on average). Enteral nutrition with elementary commercially available diet (Peptisorb) will be begun 20 hours post-surgery; it will start at an 8 ml/h flow rate and increased gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition was continued for six days. During the initial five days post-surgery, the patients will be additionally supplemented parenterally via peripheral veins; similarly to the preoperative period, the content of two-chamber bag for peripheral access enriched with glutamine and ω3-fatty acids will be administered for five days.
arm group label: IV - Perioperative parenteral immunonutrition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zbigniew Kamocki, MD PhD
role: Principal Investigator
affiliation: 2nd Department of General and Gastroenterological Surgery Medical University of Bialystok
last name: Zbigniew Kamocki, MD PhD
phone: +48606452246
email: zkamocki@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Poland
citation: Noisakran S, Gibbons RV, Songprakhon P, Jairungsri A, Ajariyakhajorn Ch, Nisalak A, Jarman RG, Malasit P, Chokephaibulkit K, Perng GC. Detection of dengue virus in platelets isolated from dengue patients. Southeast Asian J Trop Med Public Health. 2009; 40: 253-262. Mustard JF, Packham MA. Platelet phagocytosis. Sem Haematol 1968; 2: 168-184. Clawson CC, White JG.: Platelet interaction with bacteria. I Reaction phases and effects on inhibitors. Am I Pathol 1971; 65: 367-380. Kemona H, Andrzejewska A, Prokopowicz J, Nowak H, Mantur M. Phagocytic activity of human blood platelets examined by electron microscopy. Folia Haematol Int Mag Klin Morphol Blutforsch 1986; 113: 696-702. Bessler H, Agam G, Diadetti M. Increased protein synthesis by human platelets during phagocytosis of latex particles in vivo. Thromb Diath Haemorrh 1976; 35: 350-357. Tang YQ, Yeaman MR, Selsted ME. Antimicrobial peptides from human platelets. Infect Immun 2002; 70: 6524-6533. Yeaman MR. The role of platelets in antimicrobial host defense. Clin Infect Dis 1997; 5: 951-968. Page CP. Platelets as inflammatory cells. Immunopharmacology 1989; 17: 51-59. Sun B, Li J, Kambayashi J. Interaction between GPIbalpha and FcgammaIIa receptor in human platelets. Biochem Biophys Res Commun 1999; 266: 24-27. Kemona H, Andrzejewska A, Prokopowicz J, Nowak H, Mantur M. Phagocytic activity of human blood platelets examined by electron microscopy. Folia Haematol 1986; 113: 696-702. Nash GF, Turner LF, Scully MF, Kakkar AK. Platelets and cancer. Lancet Oncol 2002; 3: 425-430. Yu Y, Zhou XD, Liu YK, Ren N, Chen J. Platelets promote the adhesion of human hepatoma cells with highly metastatic potential to extracellular matrix protein: involvement of platelets P-selectin and GP IIb-IIIa. J Cancer Res Clin Oncol 2002; 128: 283-287. Kamocki Z, Matowicka-Karna J, Piotrowski Z, Kemona H. Bacteriocidal capacity of platelets in gastric cancer patients. Neoplasma 2004; 51: 265-268
responsible party type: Sponsor
mesh term: Stomach Neoplasms