<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/NCT03294096</url>
  </required_header>
  <id_info>
    <org_study_id>4-2017-0625</org_study_id>
    <nct_id>NCT03294096</nct_id>
  </id_info>
  <brief_title>Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients</brief_title>
  <official_title>Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei 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>
      Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary&#xD;
      surgery contribute impaired nutritional status in postoperative period. It can also affect&#xD;
      perioperative and oncologic outcomes negatively. Therefore it is important to improve&#xD;
      nutritional status in postoperative period by supply tailor-made optimal diets. The&#xD;
      investigators have developed customized postoperative diets and products for&#xD;
      pancreaticobiliary cancer patients. The investigators expect that nutritional supplement for&#xD;
      pancreaticobiliary patients will increase the food intake rate and contribute a improvement&#xD;
      of perioperative outcomes and even oncologic outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">July 11, 2018</completion_date>
  <primary_completion_date type="Actual">July 11, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Food Intake Rate(%) for postoperative diet</measure>
    <time_frame>Pre-operation</time_frame>
    <description>Diet Intake Rate(%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Food Intake Rate(%) for postoperative diet</measure>
    <time_frame>1 day before discharging</time_frame>
    <description>Diet Intake Rate(%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Food Intake Rate(%) for postoperative diet</measure>
    <time_frame>1 week after discharging (first outpatient follow up)</time_frame>
    <description>Diet Intake Rate(%)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Pancreaticobiliary Cancer</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Routine care + Nutritional product</intervention_name>
    <description>Routine post-op care + Nutritional supplement by specific product</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine care</intervention_name>
    <description>Routine post-op care</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (age more than 19)&#xD;
&#xD;
          -  Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal&#xD;
             pancreatectomy&#xD;
&#xD;
          -  Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater&#xD;
             cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who denied clinical trial&#xD;
&#xD;
          -  Diabetes Mellitus(DM) patient with DM complication&#xD;
&#xD;
          -  Hyperlipidemia patient with vascular co-morbidity&#xD;
&#xD;
          -  Impaired renal function or renal failure (GFP&lt;70%)&#xD;
&#xD;
          -  Poor nutritional status (PG-SGA grade C)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03294096
org study id: 4-2017-0625
nct id: NCT03294096
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary
      surgery contribute impaired nutritional status in postoperative period. It can also affect
      perioperative and oncologic outcomes negatively. Therefore it is important to improve
      nutritional status in postoperative period by supply tailor-made optimal diets. The
      investigators have developed customized postoperative diets and products for
      pancreaticobiliary cancer patients. The investigators expect that nutritional supplement for
      pancreaticobiliary patients will increase the food intake rate and contribute a improvement
      of perioperative outcomes and even oncologic outcomes.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Food Intake Rate(%) for postoperative diet
time frame: Pre-operation
description: Diet Intake Rate(%)
measure: Food Intake Rate(%) for postoperative diet
time frame: 1 day before discharging
description: Diet Intake Rate(%)
measure: Food Intake Rate(%) for postoperative diet
time frame: 1 week after discharging (first outpatient follow up)
description: Diet Intake Rate(%)
arm group label: experimental group
arm group type: Experimental
arm group label: control group
arm group type: Active Comparator
intervention type: Dietary Supplement
intervention name: Routine care + Nutritional product
description: Routine post-op care + Nutritional supplement by specific product
arm group label: experimental group
intervention type: Other
intervention name: Routine care
description: Routine post-op care
arm group label: control group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
sharing ipd: Undecided