<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/NCT01669356</url>
  </required_header>
  <id_info>
    <org_study_id>PNsupplESO</org_study_id>
    <secondary_id>Energy Supply Trial</secondary_id>
    <nct_id>NCT01669356</nct_id>
  </id_info>
  <brief_title>The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients</brief_title>
  <official_title>The Effect of Parenteral Nutrition Supplement Versus Enteral Nutrition Alone on Nutrition Status After Esophagectomy: A Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Malnutrition is common in esophagus cancer patients, especially after surgery therapy.&#xD;
      Whether parenteral supplement with enteral nutrtion is benificial for patients after&#xD;
      esophagectomy is controversial, when compared with enteral nutrition alone. In this study,&#xD;
      the investigators are to examine the effect of enteral nutrition supplemented with parenteral&#xD;
      nutrtion on nutrition status after esophagectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative laboratory parameters changes for nutrition assessment compared to preoperation</measure>
    <time_frame>from one day before surgery to the 7th postoperative day</time_frame>
    <description>plasma albumin, prealbumin, transferrin, retinaldehyde-binding protein, total lymphocytes counts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative body composition change compared to preoperation measurement</measure>
    <time_frame>from one day before surgery to the 7th postoperative day</time_frame>
    <description>postoperative body composition is compared to preoperation, bioelectrical impedance spectroscopy is used for measurement of body composition</description>
  </primary_outcome>
  <other_outcome>
    <measure>complicatons incidence after surgery</measure>
    <time_frame>28 days after surgery</time_frame>
    <description>complications involve anastomotic leakage, incision infection, pneumonia, catherter-related blood stream infection, respiratory failure</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Esophagus Cancer</condition>
  <arm_group>
    <arm_group_label>PN supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parenteral supplement with enteral nutrition for patients after esophagectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EN alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Enteral nutrition alone for patients after esophagectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parenteral supplement with enteral nutrition for patients after esophagectomy</intervention_name>
    <arm_group_label>PN supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enteral Nutrition alone for patients after esophagectomy</intervention_name>
    <arm_group_label>EN alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of esophagus cancer&#xD;
&#xD;
          -  Undergo esophagectomy&#xD;
&#xD;
          -  Nasoenteral tube is placed or surgical jejunostomy is performed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication for enteral nutrition or parenteral nutrition&#xD;
&#xD;
          -  Malnutrition before surgery ( BMI &gt; 30 or &lt; 18.5)&#xD;
&#xD;
          -  Hepatic dysfunction preoperatively&#xD;
&#xD;
          -  Renal dysfunction preoperatively&#xD;
&#xD;
          -  Infection before surgery&#xD;
&#xD;
          -  Usage of corticosteroid before surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>August 11, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>March 30, 2014</last_update_submitted>
  <last_update_submitted_qc>March 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>malnutrition</keyword>
  <keyword>parenteral supplement</keyword>
  <keyword>rest metabolic rate</keyword>
  <keyword>postoperative complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal 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/NCT01669356
org study id: PNsupplESO
secondary id: Energy Supply Trial
nct id: NCT01669356
lead sponsor: 
has dmc: No
Malnutrition is common in esophagus cancer patients, especially after surgery therapy.
      Whether parenteral supplement with enteral nutrtion is benificial for patients after
      esophagectomy is controversial, when compared with enteral nutrition alone. In this study,
      the investigators are to examine the effect of enteral nutrition supplemented with parenteral
      nutrtion on nutrition status after esophagectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: postoperative laboratory parameters changes for nutrition assessment compared to preoperation
time frame: from one day before surgery to the 7th postoperative day
description: plasma albumin, prealbumin, transferrin, retinaldehyde-binding protein, total lymphocytes counts
measure: postoperative body composition change compared to preoperation measurement
time frame: from one day before surgery to the 7th postoperative day
description: postoperative body composition is compared to preoperation, bioelectrical impedance spectroscopy is used for measurement of body composition
measure: complicatons incidence after surgery
time frame: 28 days after surgery
description: complications involve anastomotic leakage, incision infection, pneumonia, catherter-related blood stream infection, respiratory failure
arm group label: PN supplement
arm group type: Experimental
description: Parenteral supplement with enteral nutrition for patients after esophagectomy
arm group label: EN alone
arm group type: Active Comparator
description: Enteral nutrition alone for patients after esophagectomy
intervention type: Other
intervention name: Parenteral supplement with enteral nutrition for patients after esophagectomy
arm group label: PN supplement
intervention type: Other
intervention name: Enteral Nutrition alone for patients after esophagectomy
arm group label: EN alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Esophageal Neoplasms