<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/NCT01724775</url>
  </required_header>
  <id_info>
    <org_study_id>PKPH-CME</org_study_id>
    <secondary_id>Z121100005312015</secondary_id>
    <secondary_id>TG-2015-002</secondary_id>
    <secondary_id>20130001120064</secondary_id>
    <nct_id>NCT01724775</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Complete Mesocolic Excision for Colon Cancer</brief_title>
  <acronym>ESCME</acronym>
  <official_title>A Prospective, Non-randomized, Double-blind, Single-center Study to Evaluate Efficacy and Safety of Complete Mesocolic Excision for Colon Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shan Wang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In 2009, Prof. Hohenberger proposed complete mesocolic excision (CME) as standardized, in&#xD;
      which the same principle of TME in rectal cancer has been applied to the colon. More and more&#xD;
      surgeons pay attention to the rationality of this surgical approach. However, the clinical&#xD;
      application researches are still few, in particular the prospective controlled study is still&#xD;
      none. This clinical trial will compare the CME group and non-CME group to evaluate the&#xD;
      outcome and safety of CME for apply in clinic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Materials and Methods:&#xD;
&#xD;
      All the patients with colon cancer will undergo elective radical operation. The observations&#xD;
      were recorded during the operation and on the postoperative specimens. Intra-operative&#xD;
      photographs were taken at various stages, as were photographs of the postoperative specimen.&#xD;
      According to the CME operation keypoints, all the photographs will accept third-party&#xD;
      assessment of the expert group, while the third-party expert group will not participate in&#xD;
      the management of patients. Both of The evaluators and research doctors are double-blind&#xD;
      state. The postoperative patients will divided into two groups according to the results of&#xD;
      the assessment. The clinical and pathological data of the patients as well as follow-up&#xD;
      information will be recorded and collected.&#xD;
&#xD;
        1. Outcome of CME By comparison to clinicopathologic variables, and precise tissues&#xD;
           morphometry of two groups, the prognosis, lymph nodes harvest and removal of the&#xD;
           mesocolic area were investigated. Outcomes of interest also include disease-free&#xD;
           survival, local recurrence-free survival, recurrence rate. In addition, we analyzed the&#xD;
           correlation between mesocolic area and height, weight, body surface area and body mass&#xD;
           index.&#xD;
&#xD;
        2. Safety of CME CME group and non-CME group were compared the differences of security,&#xD;
           included operation time, blood loss, postoperation complications, flatus restoring time,&#xD;
           defecation restoring time, drainage removal time, Diet restoring time, drainage volume&#xD;
           in three days after surgery, hospital deaths, the exhaust time, hospitalization time and&#xD;
           hospitalization costs. In addition, the feasibility of CME techniques as the surgical&#xD;
           approach of choice for elderly patients was also evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prognosis assessment of postoperative patients</measure>
    <time_frame>yearly, up to 5 years</time_frame>
    <description>The assessment of 5-year and 3-year overall survival, disease-free survival, local recurrence rate, local recurrence-free survival for postoperative patients respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety assessment of the patients in perioperation period</measure>
    <time_frame>Daily, up to one month</time_frame>
    <description>Includes: postoperative complications, hospital mortality, operative time, blood loss, exhaust time, defecation time, drainage and unplug time, resumed eating time, drainage volume during postoperation three days and so on.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>CME surgery for colon cancer</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>non-CME surgery for colon cancer</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients of colon caner in China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of colon cancer;&#xD;
&#xD;
          -  Clinical stage Ⅰ ~ Ⅲ;&#xD;
&#xD;
          -  Undergoing colorectal surgery for the first time;&#xD;
&#xD;
          -  Accept laparotomy;&#xD;
&#xD;
          -  Accept radical resection;&#xD;
&#xD;
          -  More than 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery;&#xD;
&#xD;
          -  Preoperative neoadjuvant chemoradiotherapy history;&#xD;
&#xD;
          -  Combined with other malignant diseases;&#xD;
&#xD;
          -  Pathological stage Ⅳ patients with colon cancer.&#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>Yingjiang Ye, M.D. &amp; Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhidong Gao, M.D.</last_name>
    <phone>15810195892</phone>
    <email>xiaoya-008@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Gastroenterology Surgery, Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhidong Gao, M.D.</last_name>
      <phone>8610-88326600</phone>
      <email>xiaoya-008@163.com</email>
    </contact>
    <investigator>
      <last_name>Yingjiang Ye, M.D. &amp; Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>November 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>August 17, 2016</last_update_submitted>
  <last_update_submitted_qc>August 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>Shan Wang</investigator_full_name>
    <investigator_title>Department of Gastrointestinal Surgery</investigator_title>
  </responsible_party>
  <keyword>complete mesocolic excision</keyword>
  <keyword>colon cancer</keyword>
  <keyword>efficacy</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 24, 2021</submitted>
    <returned>September 17, 2021</returned>
  </pending_results>
  <!-- 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/NCT01724775
org study id: PKPH-CME
secondary id: Z121100005312015
secondary id: TG-2015-002
secondary id: 20130001120064
nct id: NCT01724775
lead sponsor: 
has dmc: Yes
In 2009, Prof. Hohenberger proposed complete mesocolic excision (CME) as standardized, in
      which the same principle of TME in rectal cancer has been applied to the colon. More and more
      surgeons pay attention to the rationality of this surgical approach. However, the clinical
      application researches are still few, in particular the prospective controlled study is still
      none. This clinical trial will compare the CME group and non-CME group to evaluate the
      outcome and safety of CME for apply in clinic.
Materials and Methods:

      All the patients with colon cancer will undergo elective radical operation. The observations
      were recorded during the operation and on the postoperative specimens. Intra-operative
      photographs were taken at various stages, as were photographs of the postoperative specimen.
      According to the CME operation keypoints, all the photographs will accept third-party
      assessment of the expert group, while the third-party expert group will not participate in
      the management of patients. Both of The evaluators and research doctors are double-blind
      state. The postoperative patients will divided into two groups according to the results of
      the assessment. The clinical and pathological data of the patients as well as follow-up
      information will be recorded and collected.

        1. Outcome of CME By comparison to clinicopathologic variables, and precise tissues
           morphometry of two groups, the prognosis, lymph nodes harvest and removal of the
           mesocolic area were investigated. Outcomes of interest also include disease-free
           survival, local recurrence-free survival, recurrence rate. In addition, we analyzed the
           correlation between mesocolic area and height, weight, body surface area and body mass
           index.

        2. Safety of CME CME group and non-CME group were compared the differences of security,
           included operation time, blood loss, postoperation complications, flatus restoring time,
           defecation restoring time, drainage removal time, Diet restoring time, drainage volume
           in three days after surgery, hospital deaths, the exhaust time, hospitalization time and
           hospitalization costs. In addition, the feasibility of CME techniques as the surgical
           approach of choice for elderly patients was also evaluated.
observational model: Cohort
time perspective: Prospective
measure: Prognosis assessment of postoperative patients
time frame: yearly, up to 5 years
description: The assessment of 5-year and 3-year overall survival, disease-free survival, local recurrence rate, local recurrence-free survival for postoperative patients respectively.
measure: Safety assessment of the patients in perioperation period
time frame: Daily, up to one month
description: Includes: postoperative complications, hospital mortality, operative time, blood loss, exhaust time, defecation time, drainage and unplug time, resumed eating time, drainage volume during postoperation three days and so on.
arm group label: CME surgery for colon cancer
arm group label: non-CME surgery for colon cancer
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yingjiang Ye, M.D. & Ph.D.
role: Study Director
affiliation: Peking University People's Hospital
last name: Zhidong Gao, M.D.
phone: 15810195892
email: xiaoya-008@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: Shan Wang
investigator title: Department of Gastrointestinal Surgery
mesh term: Colonic Neoplasms
sharing ipd: No
submitted: August 24, 2021
returned: September 17, 2021