<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/NCT03804762</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF2018LSK-168</org_study_id>
    <nct_id>NCT03804762</nct_id>
  </id_info>
  <brief_title>A New Method: the Third Space Robotic and Endoscopic Cooperative Surgery (TS-RECS)</brief_title>
  <official_title>Feasibility of the Third Space Robotic and Endoscopic Cooperative Surgery(TS-RECS) for Treating Gastric Stromal Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The third space robotic and endoscopic cooperative surgery (TS-RECS) combines the endoscopic&#xD;
      techniques and the merits of Da Vinci surgical robot, such as flexible and precise&#xD;
      instruments, tremors filtering system and a 3-D surgical view. TS-RECS takes full advantage&#xD;
      of the methodology of the third space, making it possible to dissect gastric GISTs&#xD;
      (gastrointestinal stromal tumors) entirely without the damage of mucosal layer. Here, this&#xD;
      study preliminarily assessed the feasibility, safety and effectivity of the novel hybrid&#xD;
      operation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 5, 2018</start_date>
  <completion_date type="Actual">December 20, 2018</completion_date>
  <primary_completion_date type="Actual">December 15, 2018</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 rate of adverse events</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>Adverse events included intraoperative adverse (full-thickness perforation, hemorrhage, injury of visceral organs and vessel, and anaesthesia complications), and postoperative adverse events (infectious complications, intra-abdominal /intraluminal bleeding, gastric stasis and leakage)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rate of en bloc resection</measure>
    <time_frame>1 day</time_frame>
    <description>the en bloc resection was defined as complete tumor resection with negative surgical margin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the rate of intact mucosal layer</measure>
    <time_frame>1 day</time_frame>
    <description>intact mucosal layer was defined as the tumor resection without full-thickness incision caused by operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operation time</measure>
    <time_frame>1 day</time_frame>
    <description>Operation time was defined from the time of docking to the time of trocar incision closure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estimated blood loss</measure>
    <time_frame>1 day</time_frame>
    <description>Blood loss was estimated through the analysis of the surgical and anaesthesiological reports.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to oral diet</measure>
    <time_frame>30 days</time_frame>
    <description>time to oral diet to assess the postoperative course.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of postoperative hospital stay</measure>
    <time_frame>30 days</time_frame>
    <description>From the day of operation to the day of discharged, duration of postoperative hospital stay to assess the postoperative course.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Gastric Soft Tissue Neoplasm</condition>
  <arm_group>
    <arm_group_label>patients received treatment of TS-RECS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>the third space robotic and endoscopic cooperative surgery</intervention_name>
    <description>This technique combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view, and take full advantage of the methodology of the third space to dissect gastric submucosal tumors.</description>
    <arm_group_label>patients received treatment of TS-RECS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with gastric GISTs originating from muscularis propria diagnosed by EUS&#xD;
             (endoscopic ultrasound)；&#xD;
&#xD;
          -  The maximal cross-sectional diameter of tumor ranging from 2cm to 5cm, or the maximal&#xD;
             cross-sectional diameter of tumor &lt;2cm but with malignant potential ( irregular shape,&#xD;
             cystic space, heterogeneity and rapid growth during follow-ups ) ；&#xD;
&#xD;
          -  No evidence of tumor metastasis on all per-operative evaluations；&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Patients with serious systemic comorbidities, such as severe heart failure,&#xD;
             respiratory failure, uncontrolled hypertension;&#xD;
&#xD;
          -  2. Patients with advanced malignant tumor;&#xD;
&#xD;
          -  3. Patients were required the emergency operation by complete intestinal obstruction,&#xD;
             perforation and hemorrhage caused by the tumor;&#xD;
&#xD;
          -  4.Patients with ulcer penetration into tumors;&#xD;
&#xD;
          -  5. Patients with the contraindications for general anesthesia;&#xD;
&#xD;
          -  6. Patients were pregnant or younger than 18 years old；&#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>Junjun She, MD,PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Xi'an Jiao Tong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Soft Tissue Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03804762
org study id: XJTU1AF2018LSK-168
nct id: NCT03804762
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The third space robotic and endoscopic cooperative surgery (TS-RECS) combines the endoscopic
      techniques and the merits of Da Vinci surgical robot, such as flexible and precise
      instruments, tremors filtering system and a 3-D surgical view. TS-RECS takes full advantage
      of the methodology of the third space, making it possible to dissect gastric GISTs
      (gastrointestinal stromal tumors) entirely without the damage of mucosal layer. Here, this
      study preliminarily assessed the feasibility, safety and effectivity of the novel hybrid
      operation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the rate of adverse events
time frame: through study completion, an average of 6 months
description: Adverse events included intraoperative adverse (full-thickness perforation, hemorrhage, injury of visceral organs and vessel, and anaesthesia complications), and postoperative adverse events (infectious complications, intra-abdominal /intraluminal bleeding, gastric stasis and leakage)
measure: rate of en bloc resection
time frame: 1 day
description: the en bloc resection was defined as complete tumor resection with negative surgical margin.
measure: the rate of intact mucosal layer
time frame: 1 day
description: intact mucosal layer was defined as the tumor resection without full-thickness incision caused by operation
measure: operation time
time frame: 1 day
description: Operation time was defined from the time of docking to the time of trocar incision closure.
measure: estimated blood loss
time frame: 1 day
description: Blood loss was estimated through the analysis of the surgical and anaesthesiological reports.
measure: time to oral diet
time frame: 30 days
description: time to oral diet to assess the postoperative course.
measure: duration of postoperative hospital stay
time frame: 30 days
description: From the day of operation to the day of discharged, duration of postoperative hospital stay to assess the postoperative course.
arm group label: patients received treatment of TS-RECS
arm group type: Experimental
intervention type: Procedure
intervention name: the third space robotic and endoscopic cooperative surgery
description: This technique combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view, and take full advantage of the methodology of the third space to dissect gastric submucosal tumors.
arm group label: patients received treatment of TS-RECS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Junjun She, MD,PHD
role: Principal Investigator
affiliation: First Affiliated Hospital Xi'an Jiaotong University
facility: 
country: China
responsible party type: Sponsor
mesh term: Soft Tissue Neoplasms
sharing ipd: Undecided