<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/NCT01697943</url>
  </required_header>
  <id_info>
    <org_study_id>2012-44-563</org_study_id>
    <nct_id>NCT01697943</nct_id>
  </id_info>
  <brief_title>Impact of Roux-En-Y Pouch Reconstruction Compared With Conventional Roux-En-Y Reconstruction on Quality of Life in Patients Undergoing Total Gastrectomy</brief_title>
  <acronym>GCQOL02</acronym>
  <official_title>A Pilot Randomized Controlled Trial Examining the Differences of Quality of Life of Roux-En-Y Pouch Reconstruction and Conventional Roux-En-Y Reconstruction in Patients Undergoing Total Gastrectomy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out more about differences of the quality of life in&#xD;
      patients undergoing Roux-En-Y pouch reconstruction and conventional Roux-En-Y reconstruction.&#xD;
      To find a better reconstruction for patients who received total gastrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total gastrectomy has been indicated mainly for advanced gastric cancer located from the&#xD;
      upper to middle third of the stomach or multiple gastric cancers.The most common method of&#xD;
      creating a way for food is called a &quot;Roux-en-Y&quot;, in which one part of the intestines is&#xD;
      connected with the end of the esophagus (the swallowing tube) in the abdomen, and another&#xD;
      connection is made between the intestines ' lower down.&#xD;
&#xD;
      Patients with total gastrectomy suffer from poor food intake, anemia, and poor digestion&#xD;
      because of loss of gastric reservoir or a lack of normal hormonal secretion for digestion. It&#xD;
      often is associated with a limitation of postoperative quality of life (QOL). To improve&#xD;
      postoperative nutritional status and QOL, surgeons have tried to establish ideal&#xD;
      reconstruction after total gastrectomy and the optimum procedure for reconstruction has been&#xD;
      discussed.&#xD;
&#xD;
      This study will compare the postoperative quality of life (QOL) of gastric pouch&#xD;
      reconstruction with the usual reconstruction to see if the pouch makes patients feel better.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in QOL (Quality of Life)</measure>
    <time_frame>5years</time_frame>
    <description>From preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nutritional status of patients</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Gastric Tumor</condition>
  <arm_group>
    <arm_group_label>Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction</intervention_name>
    <arm_group_label>Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Pathologically confirmed gastric malignant tumor at fUSCC (biopsy may be performed&#xD;
             at other institutions but slides must be confirmed at SHCA, as is routine care at our&#xD;
             institution) , and the patients be assessed must be carried out total gastrectomy by&#xD;
             three specialists.&#xD;
&#xD;
               -  Patients 20-75 years old&#xD;
&#xD;
               -  Normal organ function, able to tolerate surgery, no clear contraindication for&#xD;
                  surgery&#xD;
&#xD;
               -  No evidence of metastases of adjacent organs&#xD;
&#xD;
               -  be able to provide follow-up over 2 years&#xD;
&#xD;
               -  No specific treatment for gastric cancer before surgery&#xD;
&#xD;
               -  In line with the Declaration of Helsinki and the requirements of the hospital&#xD;
                  ethics committee.&#xD;
&#xD;
               -  The subjects were able to understand and comply with the trial protocol, and&#xD;
                  signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Synchronous or metachronous (less than five years) and with other malignancies.&#xD;
&#xD;
               -  Cirrhosis and portal hypertension&#xD;
&#xD;
               -  Associated with blood diseases&#xD;
&#xD;
               -  Serious heart/ lung and kidney dysfunction or with metabolic diseases such as&#xD;
                  diabetes, hyperthyroidism.&#xD;
&#xD;
               -  Suffering from a serious neurological diseases or psychological diseases&#xD;
                  affecting the life&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ya Nong Wang, MD,PhD</last_name>
    <phone>+86-21 64175590</phone>
    <phone_ext>1208</phone_ext>
    <email>huahuang@fudan.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hua Huang, MD,PhD</last_name>
    <phone>+86-21 64175590</phone>
    <phone_ext>1205</phone_ext>
    <email>huahuang@fudan.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ya Nong Wang, MD,PhD</last_name>
      <phone>+86-21 64175590</phone>
      <phone_ext>1208</phone_ext>
      <email>huahuang@fudan.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Hua Huang, MD,PhD</last_name>
      <phone>+86-21 64175590</phone>
      <phone_ext>1205</phone_ext>
      <email>huahuang@fudan.edu.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Ya Nong Wang, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>October 15, 2012</last_update_submitted>
  <last_update_submitted_qc>October 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Yanong Wang</investigator_full_name>
    <investigator_title>Director of Department of Abdominal Surgery</investigator_title>
  </responsible_party>
  <keyword>Gastric Malignant Tumor</keyword>
  <keyword>Total Gastrectomy</keyword>
  <keyword>Reconstruction</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/NCT01697943
org study id: 2012-44-563
nct id: NCT01697943
lead sponsor: 
has dmc: No
The purpose of this study is to find out more about differences of the quality of life in
      patients undergoing Roux-En-Y pouch reconstruction and conventional Roux-En-Y reconstruction.
      To find a better reconstruction for patients who received total gastrectomy.
Total gastrectomy has been indicated mainly for advanced gastric cancer located from the
      upper to middle third of the stomach or multiple gastric cancers.The most common method of
      creating a way for food is called a "Roux-en-Y", in which one part of the intestines is
      connected with the end of the esophagus (the swallowing tube) in the abdomen, and another
      connection is made between the intestines ' lower down.

      Patients with total gastrectomy suffer from poor food intake, anemia, and poor digestion
      because of loss of gastric reservoir or a lack of normal hormonal secretion for digestion. It
      often is associated with a limitation of postoperative quality of life (QOL). To improve
      postoperative nutritional status and QOL, surgeons have tried to establish ideal
      reconstruction after total gastrectomy and the optimum procedure for reconstruction has been
      discussed.

      This study will compare the postoperative quality of life (QOL) of gastric pouch
      reconstruction with the usual reconstruction to see if the pouch makes patients feel better.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in QOL (Quality of Life)
time frame: 5years
description: From preoperative following total gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires
measure: Nutritional status of patients
time frame: 5 years
arm group label: Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction
arm group type: Experimental
intervention type: Procedure
intervention name: Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction
arm group label: Roux-En-Y Pouch Reconstruction or Roux-En-Y Reconstruction
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ya Nong Wang, MD,PhD
phone: +86-21 64175590
phone ext: 1208
email: huahuang@fudan.edu.cn
last name: Hua Huang, MD,PhD
phone: +86-21 64175590
phone ext: 1205
email: huahuang@fudan.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Yanong Wang
investigator title: Director of Department of Abdominal Surgery
mesh term: Stomach Neoplasms