<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/NCT03811704</url>
  </required_header>
  <id_info>
    <org_study_id>201802</org_study_id>
    <nct_id>NCT03811704</nct_id>
  </id_info>
  <brief_title>Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging</brief_title>
  <official_title>Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhujiang Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate the feasibility and efficacy of a novel real-time&#xD;
      navigation way for laparoscope liver resection, which was fused images comprising 3D imaging&#xD;
      and indocyanine green Fluorescence imaging (fusion IGFI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During liver resection, surgeons cannot completely view the intraparenchymal structure.&#xD;
      Although a fluorescent imaging technique using indocyanine green has recently been developed&#xD;
      for hepatobiliary surgery, limitations in its application for real-time navigation persist. A&#xD;
      nove augmented reality surgery navigation system (ARSNS) can be combined with indocyanine&#xD;
      green Fluorescence imaging to guide the surgery real-time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <phase>Phase 2</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>Liver resection navigation success rate</measure>
    <time_frame>intraoperative</time_frame>
    <description>Whether this technique successfully displayed the pre-resection line during the surgery were recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complication rate</measure>
    <time_frame>3 months</time_frame>
    <description>The Postoperative complications were recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative outcomes</measure>
    <time_frame>intraoperative</time_frame>
    <description>Operative outcomes such as operative time, estimated blood loss and blood transfusion were recorded.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Liver Resection</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laparoscopic surgical navigation system</intervention_name>
    <description>We will use this navigation system to guide de liver resection.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indocyanine Green</intervention_name>
    <description>ICG was administered 24 hours before the operation or intravenously after clamping the Glissonian sheaths flowing in the cancer-bearing hepatic segment, or directly into the portal branches supplying blood flow to the tumor-bearing hepatic segment, after puncturing of the target segments under intraoperative ultrasonography guidance.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years≤ Age ≤70 years&#xD;
&#xD;
          2. Compling with the diagnosis criteria of complex hepatic carcinoma.&#xD;
&#xD;
          3. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer&#xD;
             metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled&#xD;
&#xD;
          4. Preoperative liver function is Child - Pugh grade A or B.&#xD;
&#xD;
          5. The patients are volunteered for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with mental illness.&#xD;
&#xD;
          2. Patients can't tolerate the operation owe to a variety of basic diseases (such as&#xD;
             severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system&#xD;
             diseases, etc.)&#xD;
&#xD;
          3. The patients refused to take part in the study.&#xD;
&#xD;
          4. There are other co-existed malignant tumors.&#xD;
&#xD;
          5. Benign liver diseases.&#xD;
&#xD;
          6. Indocyanine green allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chihua Fang, M.D.;Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>China, Guangdong Zhujiang Hospital of The Southern Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fang Chihua, M.D.;Ph.D</last_name>
    <phone>+8613609700805</phone>
    <email>fangch_dr@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhujiang Hospital of Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510282</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chihua Fang, MD</last_name>
      <phone>(+86)2062782568</phone>
      <email>s_mountain@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Qingshan Chen, MM</last_name>
      <phone>(+86)2062782568</phone>
      <email>s_mountain@126.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>three-dimensional reconstruction</keyword>
  <keyword>fluorescence</keyword>
  <keyword>indocyanine green</keyword>
  <keyword>liver resection</keyword>
  <keyword>navigation surgery</keyword>
  <!-- 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/NCT03811704
org study id: 201802
nct id: NCT03811704
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to evaluate the feasibility and efficacy of a novel real-time
      navigation way for laparoscope liver resection, which was fused images comprising 3D imaging
      and indocyanine green Fluorescence imaging (fusion IGFI).
During liver resection, surgeons cannot completely view the intraparenchymal structure.
      Although a fluorescent imaging technique using indocyanine green has recently been developed
      for hepatobiliary surgery, limitations in its application for real-time navigation persist. A
      nove augmented reality surgery navigation system (ARSNS) can be combined with indocyanine
      green Fluorescence imaging to guide the surgery real-time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Liver resection navigation success rate
time frame: intraoperative
description: Whether this technique successfully displayed the pre-resection line during the surgery were recorded.
measure: Postoperative complication rate
time frame: 3 months
description: The Postoperative complications were recorded.
measure: Operative outcomes
time frame: intraoperative
description: Operative outcomes such as operative time, estimated blood loss and blood transfusion were recorded.
arm group label: Experimental group
arm group type: Experimental
description: Hepatectomy procedures were performed under Laparoscopic surgical navigation system and Indocyanine Green guidance.
intervention type: Device
intervention name: Laparoscopic surgical navigation system
description: We will use this navigation system to guide de liver resection.
arm group label: Experimental group
intervention type: Drug
intervention name: Indocyanine Green
description: ICG was administered 24 hours before the operation or intravenously after clamping the Glissonian sheaths flowing in the cancer-bearing hepatic segment, or directly into the portal branches supplying blood flow to the tumor-bearing hepatic segment, after puncturing of the target segments under intraoperative ultrasonography guidance.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Chihua Fang, M.D.;Ph.D
role: Study Director
affiliation: China, Guangdong Zhujiang Hospital of The Southern Medical University
last name: Fang Chihua, M.D.;Ph.D
phone: +8613609700805
email: fangch_dr@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor