<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/NCT04479111</url>
  </required_header>
  <id_info>
    <org_study_id>CRCCZ-S02</org_study_id>
    <nct_id>NCT04479111</nct_id>
  </id_info>
  <brief_title>Laparoscopic IIeocecus-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon</brief_title>
  <acronym>LISH</acronym>
  <official_title>An Open, Single-arm, Single Center, Clinical Trial to Investigate the Feasibility and Safety of Laparoscopic Ileocecus-sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang 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>
      To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and&#xD;
      oncologically safe&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our study is a single arm, single center clinical trial. The enrolled patients will accept&#xD;
      laparoscopic ileocecus-sparing right hemicolectomy. The primary endpoint: postoperative&#xD;
      complications, 1-year local recurrence. The second endpoint: conversion to conventional right&#xD;
      hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year&#xD;
      disease free survival, R0 resection, Specimen morphometry&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">January 1, 2023</completion_date>
  <primary_completion_date type="Actual">December 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>up to 90 days after surgery</time_frame>
    <description>Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>1-year local recurrence</measure>
    <time_frame>7 days after surgery</time_frame>
    <description>rate of local recurrence one year after surgery, including anastomotic recurrence, recurrence around ileocolic vessels and surgical trunk of superior mesenteric vein,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Conversion to conventional right hemicolectomy</measure>
    <time_frame>1 day of surgery</time_frame>
    <description>the rate of conversion to conventional right hemicolectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first flatus after surgery</measure>
    <time_frame>up to 7 days after surgery</time_frame>
    <description>days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of harvested lymph nodes</measure>
    <time_frame>up to 1 week after surgery</time_frame>
    <description>Number of harvested Lymph nodes according to the pathological report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0 resection</measure>
    <time_frame>up to 1 week after surgery</time_frame>
    <description>Rate of resection without any affected margins during the surgical procedure according to the pathological report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specimen morphometry</measure>
    <time_frame>within 30 days</time_frame>
    <description>The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year disease free survival</measure>
    <time_frame>3 years</time_frame>
    <description>the time from enrollment until disease relapse or death from any cause 3 years after surgery</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Hepatic Flexure Colon Cancer</condition>
  <condition>Proximal Transverse Colon Cancer</condition>
  <arm_group>
    <arm_group_label>LISRH group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following the principle of complete mesocolic excision(CME), Ileocecus-Sparing Right colectomy refers to the resection of the most portion of the ascending colon, hepatic flexure and mid to distal transverse colon. The extent of lymph node dissection and length of distal resection margin are similar to conventional right hemicolectomy. The length of proximal resection margin varies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic ileocecus-sparing right hemicolectomy</intervention_name>
    <description>The ileocecal artery(ICA) is skeletonized. The colic branch of ICA is divided and ligated. Preserve anterior cecal artery, posterior cecal artery and ileocecal branch of ICA. Divide and ligate the right colic artery(RCA) and middle colic artery(MCA) at their roots. Dissect the lymph nodes surrounding the ICA, RCA and MCA accordingly. Head-to-Head colocolic anastomois is done, with circular stapler via making an opening at the bottom of cecum.</description>
    <arm_group_label>LISRH group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients suitable for curative surgery 18-75years old&#xD;
&#xD;
          2. ASA grade I-III&#xD;
&#xD;
          3. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;&#xD;
&#xD;
          4. Localization diagnosis: the tumor located at hepatic flexure and proximal transverse&#xD;
             colon(proximal to the right branch of middle colic artery);&#xD;
&#xD;
          5. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is&#xD;
             T1-T4N0 or TanyN+; there is no distant metastasis.&#xD;
&#xD;
          6. Intraoperative measurement: the distance between colic branch of ileocolic artery and&#xD;
             proximal edge of the tumor should be longer than 5cm.&#xD;
&#xD;
          7. Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Simultaneous or metachronous multiple primary colorectal cancer;&#xD;
&#xD;
          2. History of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.&#xD;
&#xD;
          3. Preoperative imaging examination results show: fused lymph node at the root of&#xD;
             ileocolic artery.&#xD;
&#xD;
          4. Distant metastasis.&#xD;
&#xD;
          5. History of any other malignant tumor in recent 5 years.&#xD;
&#xD;
          6. Patients need emergency operation.&#xD;
&#xD;
          7. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal&#xD;
             surgery, not suitable for artificial pneumoperitoneum, etc).&#xD;
&#xD;
          8. Informed consent refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>KeFeng Ding, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang University</investigator_affiliation>
    <investigator_full_name>Ding Ke-Feng</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>hepatic flexure colon cancer</keyword>
  <keyword>proximal transverse colon cancer</keyword>
  <keyword>ileocecus-sparing</keyword>
  <keyword>laparoscopic right hemicolectomy</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>
  <!-- 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/NCT04479111
org study id: CRCCZ-S02
nct id: NCT04479111
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and
      oncologically safe
Our study is a single arm, single center clinical trial. The enrolled patients will accept
      laparoscopic ileocecus-sparing right hemicolectomy. The primary endpoint: postoperative
      complications, 1-year local recurrence. The second endpoint: conversion to conventional right
      hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year
      disease free survival, R0 resection, Specimen morphometry
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative complications
time frame: up to 90 days after surgery
description: Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded
measure: 1-year local recurrence
time frame: 7 days after surgery
description: rate of local recurrence one year after surgery, including anastomotic recurrence, recurrence around ileocolic vessels and surgical trunk of superior mesenteric vein,
measure: Conversion to conventional right hemicolectomy
time frame: 1 day of surgery
description: the rate of conversion to conventional right hemicolectomy
measure: Time to first flatus after surgery
time frame: up to 7 days after surgery
description: days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery
measure: Number of harvested lymph nodes
time frame: up to 1 week after surgery
description: Number of harvested Lymph nodes according to the pathological report
measure: R0 resection
time frame: up to 1 week after surgery
description: Rate of resection without any affected margins during the surgical procedure according to the pathological report
measure: Specimen morphometry
time frame: within 30 days
description: The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length
measure: 3-year disease free survival
time frame: 3 years
description: the time from enrollment until disease relapse or death from any cause 3 years after surgery
arm group label: LISRH group
arm group type: Experimental
description: Following the principle of complete mesocolic excision(CME), Ileocecus-Sparing Right colectomy refers to the resection of the most portion of the ascending colon, hepatic flexure and mid to distal transverse colon. The extent of lymph node dissection and length of distal resection margin are similar to conventional right hemicolectomy. The length of proximal resection margin varies.
intervention type: Procedure
intervention name: laparoscopic ileocecus-sparing right hemicolectomy
description: The ileocecal artery(ICA) is skeletonized. The colic branch of ICA is divided and ligated. Preserve anterior cecal artery, posterior cecal artery and ileocecal branch of ICA. Divide and ligate the right colic artery(RCA) and middle colic artery(MCA) at their roots. Dissect the lymph nodes surrounding the ICA, RCA and MCA accordingly. Head-to-Head colocolic anastomois is done, with circular stapler via making an opening at the bottom of cecum.
arm group label: LISRH group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: KeFeng Ding, PhD
role: Principal Investigator
affiliation: Zhejiang University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhejiang University
investigator full name: Ding Ke-Feng
investigator title: Professor
mesh term: Colonic Neoplasms
sharing ipd: No