<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/NCT03238820</url>
  </required_header>
  <id_info>
    <org_study_id>BE2015687GIST</org_study_id>
    <nct_id>NCT03238820</nct_id>
  </id_info>
  <brief_title>Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study</brief_title>
  <official_title>Robotic Resection for Patients With Gastric Gastrointestinal Stromal Tumors: a Single-center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JIANG Zhi-Wei</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jinling Hospital, China</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>
      Patients with gastric gastrointestinal stromal tumors will receive robotic resection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastrointestinal stromal tumors are the most common stromal tumors of the digestive tract.&#xD;
      Approximately 60% of tumors develop in the stomach.Before, patients with gastric&#xD;
      gastrointestinal stromal tumors would receive open or laparoscopic surgery. However,&#xD;
      gastrointestinal stromal tumors located at special sites, such as cardia, were hardly&#xD;
      treated. Recently, the robot was used to remove gastric gastrointestinal stromal tumors. In&#xD;
      this study, the robot will be used to remove gastric gastrointestinal stromal tumors. Then,&#xD;
      we will evaluate the effect of robotic gastric gastrointestinal stromal tumors resection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2014</start_date>
  <completion_date type="Actual">June 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 5, 2016</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>
    <intervention_model_description>This is a single group, open study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complications</measure>
    <time_frame>1 month</time_frame>
    <description>Intraoperative and postoperative complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>1 day</time_frame>
    <description>Blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>1 day</time_frame>
    <description>Operative time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resection style</measure>
    <time_frame>1 day</time_frame>
    <description>The wedge resection, gastrotomy, partial gastrectomy and total gastrectomy were selected based on tumor size and site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative length of stay</measure>
    <time_frame>1 month</time_frame>
    <description>Postoperative length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation level</measure>
    <time_frame>1 month</time_frame>
    <description>Inflammation level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status</measure>
    <time_frame>6 months</time_frame>
    <description>Nutritional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>6 months</time_frame>
    <description>Body composition</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Gastrointestinal Stromal Tumor of Stomach</condition>
  <arm_group>
    <arm_group_label>The robot group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo robotic gastric gastrointestinal stromal tumors resection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Robotic gastric gastrointestinal stromal tumors resection</intervention_name>
    <description>Robotic gastric gastrointestinal stromal tumors resection</description>
    <arm_group_label>The robot group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Requirements of informed consent and assent of participant, parent or legal guardian&#xD;
             as applicable.&#xD;
&#xD;
          2. Patients with gastric gastrointestinal stromal tumors scheduled for robotic resection&#xD;
             and between the age of 18 and 80 years old without considering sex.&#xD;
&#xD;
          3. American Society of Anesthesiologists (ASA) physical status I-III.&#xD;
&#xD;
          4. Participants can follow the visit plan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients certified by a doctor that doesn't fit to participate in this study.&#xD;
&#xD;
          2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular&#xD;
             disease, or their cardiac function &gt; II (NYHA) patients, patients received coronary&#xD;
             artery bypass grafting (CABG) recently, and patients with severe hypertension&#xD;
             (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).&#xD;
&#xD;
          3. Patients with gastrointestinal stromal tumor with distant metastasis.&#xD;
&#xD;
          4. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe&#xD;
             liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance &lt; 25 ml/min).&#xD;
&#xD;
          5. Patients with gastrointestinal operations and complicated abdominal operations.&#xD;
&#xD;
          6. Patients with severe malnutrition (albumin≤30g/L, weight loss in half a year&gt;10%,&#xD;
             Subjective Global Assessment (SGA) classification C, body mass index &lt;18, Hb&lt;70g/L).&#xD;
&#xD;
          7. Pregnancy and lactation women, or have a pregnancy plan within a month after the test&#xD;
             of the subjects (also including male participants).&#xD;
&#xD;
          8. Patients participated other subjects 3 months before this subject.&#xD;
&#xD;
          9. Sponsors or researchers directly involved in the testing or their family members.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhi-Wei JIANG, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jinling Hospital, Medical School of Nanjing University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jian ZHAO, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Jinling Hospital, Medical School of Nanjing University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jinling Hospital, Medical School of Nanjing University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>JIANG Zhi-Wei</investigator_full_name>
    <investigator_title>Vice director of Research Institute of General Surgery</investigator_title>
  </responsible_party>
  <keyword>Gastrointestinal stromal tumors</keyword>
  <keyword>Robot</keyword>
  <keyword>manual suture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Stromal Tumors</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The results and IPD might be considered to share in published articles.</ipd_description>
  </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/NCT03238820
org study id: BE2015687GIST
nct id: NCT03238820
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with gastric gastrointestinal stromal tumors will receive robotic resection.
Gastrointestinal stromal tumors are the most common stromal tumors of the digestive tract.
      Approximately 60% of tumors develop in the stomach.Before, patients with gastric
      gastrointestinal stromal tumors would receive open or laparoscopic surgery. However,
      gastrointestinal stromal tumors located at special sites, such as cardia, were hardly
      treated. Recently, the robot was used to remove gastric gastrointestinal stromal tumors. In
      this study, the robot will be used to remove gastric gastrointestinal stromal tumors. Then,
      we will evaluate the effect of robotic gastric gastrointestinal stromal tumors resection.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a single group, open study.
primary purpose: Treatment
masking: None (Open Label)
measure: Complications
time frame: 1 month
description: Intraoperative and postoperative complications
measure: Blood loss
time frame: 1 day
description: Blood loss
measure: Operative time
time frame: 1 day
description: Operative time
measure: Resection style
time frame: 1 day
description: The wedge resection, gastrotomy, partial gastrectomy and total gastrectomy were selected based on tumor size and site.
measure: Postoperative length of stay
time frame: 1 month
description: Postoperative length of stay
measure: Inflammation level
time frame: 1 month
description: Inflammation level
measure: Nutritional status
time frame: 6 months
description: Nutritional status
measure: Body composition
time frame: 6 months
description: Body composition
arm group label: The robot group
arm group type: Experimental
description: Patients undergo robotic gastric gastrointestinal stromal tumors resection.
intervention type: Procedure
intervention name: Robotic gastric gastrointestinal stromal tumors resection
description: Robotic gastric gastrointestinal stromal tumors resection
arm group label: The robot group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zhi-Wei JIANG, Ph.D.
role: Principal Investigator
affiliation: Jinling Hospital, Medical School of Nanjing University
last name: Jian ZHAO, Ph.D.
role: Study Director
affiliation: Jinling Hospital, Medical School of Nanjing University
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: JIANG Zhi-Wei
investigator title: Vice director of Research Institute of General Surgery
mesh term: Gastrointestinal Stromal Tumors
mesh term: Stomach Neoplasms
sharing ipd: Undecided
ipd description: The results and IPD might be considered to share in published articles.