<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/NCT01696682</url>
  </required_header>
  <id_info>
    <org_study_id>ZSchest2012001</org_study_id>
    <nct_id>NCT01696682</nct_id>
  </id_info>
  <brief_title>The Optimal Width of Gastric Conduit for Minimally Invasive Esophagectomy: Wide or Narrow?</brief_title>
  <official_title>Study on the Difference of Anastomotic Leakage Ratio Between Wide and Narrow Gastric Conduit During Minimally Invasive Esophagectomy</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 study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize&#xD;
      anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this&#xD;
      random-controlled research, and investigate the leakage ratio from different widths of&#xD;
      gastric conduit formed during the operation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University&#xD;
      will be enrolled and be assigned to wide or narrow gastric conduit group randomly.&#xD;
      Intra-operative blood supply and vascular SaO2 will be observed during the operation, and the&#xD;
      rate of anastomotic leakage, together with its clinical details will be recorded in the two&#xD;
      groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The anastomotic leakage rate</measure>
    <time_frame>the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks</time_frame>
    <description>The anastomotic leakage is a severe complication following minimally invasive esophagectomy. The definition of anastomotic leakage is determined as per the STS (SOCIETY OF THORACIC SURGEONS) database.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Anastomotic Leakage</condition>
  <arm_group>
    <arm_group_label>Narrow Gastric Conduit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group in which narrowed gastric conduit will be performed during minimally invasive esophagectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wide Gastric Conduit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group in which widened gastric conduit will be performed during minimally invasive esophagectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Narrowed Gastric Conduit</intervention_name>
    <description>The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy</description>
    <arm_group_label>Narrow Gastric Conduit</arm_group_label>
    <other_name>Narrowed Gastric Tube</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Widened Gastric Conduit</intervention_name>
    <description>A widened gastric tube will be formed during the surgery</description>
    <arm_group_label>Wide Gastric Conduit</arm_group_label>
    <other_name>Wide Gastric Tube</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients underwent minimally invasive esophagectomy(three-hole procedure)&#xD;
&#xD;
          2. Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as&#xD;
             T1-3N0M0 esophageal cancer after neo-adjuvant therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. With previous cancer history&#xD;
&#xD;
          2. Severe Co-morbidity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lijie Tan, MD</last_name>
    <role>Study Director</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yaxing Shen, MD</last_name>
    <phone>86-13661983366</phone>
    <email>SHEN.YAXING@ZS-HOSPITAL.SH.CN</email>
  </overall_contact>
  <location>
    <facility>
      <name>Division of Thoracic Surgery, Zhongshan Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yaxing Shen, MD</last_name>
      <phone>86-13661983366</phone>
      <email>shen.yaxing@zs-hospital.sh.cn</email>
    </contact>
    <investigator>
      <last_name>Hao Wang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>September 22, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>February 7, 2013</last_update_submitted>
  <last_update_submitted_qc>February 7, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Tan, Lijie</investigator_full_name>
    <investigator_title>Associate Professor of Surgery; Vice Chief, Division of Thoracic Surgery</investigator_title>
  </responsible_party>
  <keyword>minimally invasive esophagectomy</keyword>
  <keyword>anastomotic leakage</keyword>
  <keyword>gastric conduit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anastomotic Leak</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/NCT01696682
org study id: ZSchest2012001
nct id: NCT01696682
lead sponsor: 
has dmc: No
The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize
      anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this
      random-controlled research, and investigate the leakage ratio from different widths of
      gastric conduit formed during the operation.
Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University
      will be enrolled and be assigned to wide or narrow gastric conduit group randomly.
      Intra-operative blood supply and vascular SaO2 will be observed during the operation, and the
      rate of anastomotic leakage, together with its clinical details will be recorded in the two
      groups.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: The anastomotic leakage rate
time frame: the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks
description: The anastomotic leakage is a severe complication following minimally invasive esophagectomy. The definition of anastomotic leakage is determined as per the STS (SOCIETY OF THORACIC SURGEONS) database.
arm group label: Narrow Gastric Conduit
arm group type: Experimental
description: The group in which narrowed gastric conduit will be performed during minimally invasive esophagectomy
arm group label: Wide Gastric Conduit
arm group type: Experimental
description: The group in which widened gastric conduit will be performed during minimally invasive esophagectomy
intervention type: Procedure
intervention name: Narrowed Gastric Conduit
description: The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy
arm group label: Narrow Gastric Conduit
other name: Narrowed Gastric Tube
intervention type: Procedure
intervention name: Widened Gastric Conduit
description: A widened gastric tube will be formed during the surgery
arm group label: Wide Gastric Conduit
other name: Wide Gastric Tube
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lijie Tan, MD
role: Study Director
affiliation: Fudan University
last name: Yaxing Shen, MD
phone: 86-13661983366
email: SHEN.YAXING@ZS-HOSPITAL.SH.CN
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Tan, Lijie
investigator title: Associate Professor of Surgery; Vice Chief, Division of Thoracic Surgery
mesh term: Anastomotic Leak