<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/NCT04423354</url>
  </required_header>
  <id_info>
    <org_study_id>WWang</org_study_id>
    <nct_id>NCT04423354</nct_id>
  </id_info>
  <brief_title>A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Ⅱ AEG</brief_title>
  <official_title>A Prospective Clinical Study of Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial Hospital of Traditional Chinese Medicine</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>
      Objective: To evaluate the safety, feasibility and clinical efficacy of transthoracic&#xD;
      single-hole assisted laparoscopic radical gastrectomy for Siewert Type Ⅱ adenocarcinoma of&#xD;
      esophagogastric junction.&#xD;
&#xD;
      Methods: A prospective, single-center, one-arm study will be performed. Patients who have&#xD;
      been diagnosed with Siewert type Ⅱ esophagogastric junction adenocarcinoma and meet the&#xD;
      eligibility criteria will be included in the study and undergo the transthoracic single-hole&#xD;
      assisted laparoscopic radical gastrectomy. The data of preoperative, intraoperative,&#xD;
      postoperative and follow-up will be recorded and analyzed.&#xD;
&#xD;
      Primary study endpoints: The incidences of early postoperative complications and mortality.&#xD;
&#xD;
      The secondary study endpoints:(1) Surgery and oncology indicators ;(2) Early postoperative&#xD;
      recovery information ;(3) 3-year disease-free survival and overall survival rate;(4) 5-year&#xD;
      disease-free survival and overall survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Surgery and oncology indicators,such as length of operation, intraoperative blood loss,&#xD;
           transit thoracotomy or laparotomy rate, length of proximal tumor from esophageal&#xD;
           resection margin, number of mediastinal lymph node dissections and the positive, number&#xD;
           of abdominal lymph node dissections and the positive, tumor type and pathological stage,&#xD;
           etc.;&#xD;
&#xD;
        2. Early postoperative recovery information ,such as time of first exhaust and defecation,&#xD;
           time of leaving the bed, time of recovery of full and half-flow diet, time of removal of&#xD;
           chest drainage tube, time of postoperative hospitalization, etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2024</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>The incidences of early perioperative complications</measure>
    <time_frame>Within 30 days after surgery</time_frame>
    <description>The early perioperative complications include anastomotic fistula, anastomotic stenosis, gastrointestinal dysfunction, chest or abdominal infection, chest or abdominal hemorrhage, respiratory complications, cardiovascular and cerebrovascular accidents, embolism and so on.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perioperative mortality</measure>
    <time_frame>Within 30 days after surgery</time_frame>
    <description>The incidence of death due to the surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of operation</measure>
    <time_frame>From the beginning of anesthesia to the completion of surgery</time_frame>
    <description>The time it takes to complete the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>From the beginning of anesthesia to the completion of surgery</time_frame>
    <description>Total blood lost during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of transit thoracotomy or laparotomy</measure>
    <time_frame>From the beginning of anesthesia to the completion of surgery</time_frame>
    <description>Thoracic or abdominal incisions greater than 10cm are considered to be converted to open chest or abdomen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative mortality</measure>
    <time_frame>From the beginning of anesthesia to the completion of surgery</time_frame>
    <description>The rate of death during the surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proximal marginal distance</measure>
    <time_frame>From the beginning of anesthesia to the completion of surgery</time_frame>
    <description>The length of proximal tumor from esophageal resection margin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of mediastinal lymph node dissections and the positive</measure>
    <time_frame>About 7 days.</time_frame>
    <description>The mediastinal lymph nodes include NO.19,NO.20,NO.105,NO.106,NO.107,NO.108,NO.109,N0.110,NO.111,NO.112.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of abdominal lymph node dissections and the positive</measure>
    <time_frame>About 7 days.</time_frame>
    <description>The abdominal lymph nodes include NO.1,NO.2,NO.3,NO.4,NO.5,NO.6,NO.7,NO.8,NO.9,NO.10,NO.11,NO.12,NO.13,NO.14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The tumor type</measure>
    <time_frame>About 7 days.</time_frame>
    <description>Such as squamous cell carcinoma, adenocarcinoma, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The pathological stage</measure>
    <time_frame>About 7 days.</time_frame>
    <description>Refer to AJCC 8th Edition TNM staging criteria for esophagus and esophagogastric junction cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of first exhaust</measure>
    <time_frame>Time from end of surgery to discharge,about 7 days.</time_frame>
    <description>The duration from the end of the operation to the first exhaust after the operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of first defecation</measure>
    <time_frame>Time from end of surgery to discharge,about 7 days.</time_frame>
    <description>The duration from the end of the operation to the first defecation after the operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of first leaving the bed</measure>
    <time_frame>Time from end of surgery to discharge,about 7 days.</time_frame>
    <description>The duration from the end of the operation to the first leaving the bed after the operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of restoration of full flow diet</measure>
    <time_frame>Time from end of surgery to discharge,about 7 days.</time_frame>
    <description>The duration from the end of the operation to restore to a full-flow diet after the operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of restoration of half-flow diet</measure>
    <time_frame>Time from end of surgery to discharge,about 7 days.</time_frame>
    <description>The duration from the end of the operation to restore to a half-flow diet after the operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of removal of chest drainage tube</measure>
    <time_frame>Time from end of surgery to discharge,about 7 days.</time_frame>
    <description>The duration from the end of the operation to remove the chest drainage tube after the operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of postoperative hospitalization</measure>
    <time_frame>Time from end of surgery to discharge,about 7 days.</time_frame>
    <description>The duration from the end of the operation to hospital discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year overall survival rate</measure>
    <time_frame>3 years after surgery</time_frame>
    <description>Overall survival rate during 3 years after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-year disease-free survival rate</measure>
    <time_frame>3 years after surgery</time_frame>
    <description>Disease-free survival rate during 3 years after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-year overall survival rate</measure>
    <time_frame>5 years after surgery</time_frame>
    <description>Overall survival rate during 5 years after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-year disease-free survival rate</measure>
    <time_frame>5 years after surgery</time_frame>
    <description>Disease-free survival rate during 5 years after surgery</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">94</enrollment>
  <condition>Esophagogastric Junction Adenocarcinoma</condition>
  <condition>Siewert Type II Adenocarcinoma of Esophagogastric Junction</condition>
  <arm_group>
    <arm_group_label>Research group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction</intervention_name>
    <description>Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy by the fixed surgical group.The same model surgical instruments will be provided by the same instrument company.</description>
    <arm_group_label>Research group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent of patients;&#xD;
&#xD;
          -  The tumor invaded the anatomy esophagogastric junction (EGJ), with the tumor center&#xD;
             located at the EGJ line from 1cm above to 2cm below(SiewertⅡ).&#xD;
&#xD;
          -  The endoscopic biopsy was diagnosed with adenocarcinoma;&#xD;
&#xD;
          -  Preoperative clinical staging was cT1-4aNanyM0&#xD;
&#xD;
          -  No distant metastasis and invasion of surrounding organs were found;&#xD;
&#xD;
          -  ECOG score ranged from 0 to 1;&#xD;
&#xD;
          -  ASA score ranged from I to III.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Have a severe mental illness&#xD;
&#xD;
          -  History of esophagectomy and gastrectomy (including EMR / ESD for gastric and&#xD;
             esophageal cancer)&#xD;
&#xD;
          -  History of other malignant tumors within 5 years&#xD;
&#xD;
          -  History of unstable angina pectoris or myocardial infarction within 6 months&#xD;
&#xD;
          -  FEV1% of pulmonary function test was less than 50% of expected value&#xD;
&#xD;
          -  History of cerebral infarction or cerebral hemorrhage within 6 months&#xD;
&#xD;
          -  Have severe liver and kidney damage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>wei wang, M.D.,Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong PHTCM</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>wei wang, M.D.,Ph.D</last_name>
    <phone>+86-13922255515</phone>
    <email>ww1640@yeah.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>yuling xue, M.M.</last_name>
    <phone>+86-15014167320</phone>
    <email>xueyuling1994@yeah.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Wang, M.D.,PH.D.</last_name>
      <phone>+86-13922255515</phone>
      <email>wangwei16400@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Wenjun Xiong, M.D.</last_name>
      <phone>+86-15920553177</phone>
      <email>xiongwj1988@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Wei Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jin Wan</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wen jun Xiong</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yan sheng Zheng</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Li jie Luo</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jin Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>March 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 7, 2020</last_update_submitted>
  <last_update_submitted_qc>June 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Provincial Hospital of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Wei Wang</investigator_full_name>
    <investigator_title>Chief physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <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/NCT04423354
org study id: WWang
nct id: NCT04423354
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To evaluate the safety, feasibility and clinical efficacy of transthoracic
      single-hole assisted laparoscopic radical gastrectomy for Siewert Type Ⅱ adenocarcinoma of
      esophagogastric junction.

      Methods: A prospective, single-center, one-arm study will be performed. Patients who have
      been diagnosed with Siewert type Ⅱ esophagogastric junction adenocarcinoma and meet the
      eligibility criteria will be included in the study and undergo the transthoracic single-hole
      assisted laparoscopic radical gastrectomy. The data of preoperative, intraoperative,
      postoperative and follow-up will be recorded and analyzed.

      Primary study endpoints: The incidences of early postoperative complications and mortality.

      The secondary study endpoints:(1) Surgery and oncology indicators ;(2) Early postoperative
      recovery information ;(3) 3-year disease-free survival and overall survival rate;(4) 5-year
      disease-free survival and overall survival.
1. Surgery and oncology indicators,such as length of operation, intraoperative blood loss,
           transit thoracotomy or laparotomy rate, length of proximal tumor from esophageal
           resection margin, number of mediastinal lymph node dissections and the positive, number
           of abdominal lymph node dissections and the positive, tumor type and pathological stage,
           etc.;

        2. Early postoperative recovery information ,such as time of first exhaust and defecation,
           time of leaving the bed, time of recovery of full and half-flow diet, time of removal of
           chest drainage tube, time of postoperative hospitalization, etc.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The incidences of early perioperative complications
time frame: Within 30 days after surgery
description: The early perioperative complications include anastomotic fistula, anastomotic stenosis, gastrointestinal dysfunction, chest or abdominal infection, chest or abdominal hemorrhage, respiratory complications, cardiovascular and cerebrovascular accidents, embolism and so on.
measure: Perioperative mortality
time frame: Within 30 days after surgery
description: The incidence of death due to the surgery
measure: Duration of operation
time frame: From the beginning of anesthesia to the completion of surgery
description: The time it takes to complete the operation
measure: Intraoperative blood loss
time frame: From the beginning of anesthesia to the completion of surgery
description: Total blood lost during surgery
measure: The rate of transit thoracotomy or laparotomy
time frame: From the beginning of anesthesia to the completion of surgery
description: Thoracic or abdominal incisions greater than 10cm are considered to be converted to open chest or abdomen.
measure: Intraoperative mortality
time frame: From the beginning of anesthesia to the completion of surgery
description: The rate of death during the surgery.
measure: Proximal marginal distance
time frame: From the beginning of anesthesia to the completion of surgery
description: The length of proximal tumor from esophageal resection margin.
measure: The number of mediastinal lymph node dissections and the positive
time frame: About 7 days.
description: The mediastinal lymph nodes include NO.19,NO.20,NO.105,NO.106,NO.107,NO.108,NO.109,N0.110,NO.111,NO.112.
measure: The number of abdominal lymph node dissections and the positive
time frame: About 7 days.
description: The abdominal lymph nodes include NO.1,NO.2,NO.3,NO.4,NO.5,NO.6,NO.7,NO.8,NO.9,NO.10,NO.11,NO.12,NO.13,NO.14.
measure: The tumor type
time frame: About 7 days.
description: Such as squamous cell carcinoma, adenocarcinoma, etc.
measure: The pathological stage
time frame: About 7 days.
description: Refer to AJCC 8th Edition TNM staging criteria for esophagus and esophagogastric junction cancer
measure: The duration of first exhaust
time frame: Time from end of surgery to discharge,about 7 days.
description: The duration from the end of the operation to the first exhaust after the operation.
measure: The duration of first defecation
time frame: Time from end of surgery to discharge,about 7 days.
description: The duration from the end of the operation to the first defecation after the operation.
measure: The duration of first leaving the bed
time frame: Time from end of surgery to discharge,about 7 days.
description: The duration from the end of the operation to the first leaving the bed after the operation.
measure: The duration of restoration of full flow diet
time frame: Time from end of surgery to discharge,about 7 days.
description: The duration from the end of the operation to restore to a full-flow diet after the operation.
measure: The duration of restoration of half-flow diet
time frame: Time from end of surgery to discharge,about 7 days.
description: The duration from the end of the operation to restore to a half-flow diet after the operation.
measure: The duration of removal of chest drainage tube
time frame: Time from end of surgery to discharge,about 7 days.
description: The duration from the end of the operation to remove the chest drainage tube after the operation.
measure: The duration of postoperative hospitalization
time frame: Time from end of surgery to discharge,about 7 days.
description: The duration from the end of the operation to hospital discharge.
measure: 3-year overall survival rate
time frame: 3 years after surgery
description: Overall survival rate during 3 years after surgery
measure: 3-year disease-free survival rate
time frame: 3 years after surgery
description: Disease-free survival rate during 3 years after surgery
measure: 5-year overall survival rate
time frame: 5 years after surgery
description: Overall survival rate during 5 years after surgery
measure: 5-year disease-free survival rate
time frame: 5 years after surgery
description: Disease-free survival rate during 5 years after surgery
arm group label: Research group
arm group type: Experimental
description: Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy.
intervention type: Procedure
intervention name: Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction
description: Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy by the fixed surgical group.The same model surgical instruments will be provided by the same instrument company.
arm group label: Research group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 78 Years
healthy volunteers: No
last name: wei wang, M.D.,Ph.D
role: Principal Investigator
affiliation: Guangdong PHTCM
last name: wei wang, M.D.,Ph.D
phone: +86-13922255515
email: ww1640@yeah.net
last name: yuling xue, M.M.
phone: +86-15014167320
email: xueyuling1994@yeah.net
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
investigator full name: Wei Wang
investigator title: Chief physician
mesh term: Adenocarcinoma
mesh term: Esophageal Neoplasms