xml: <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/NCT06033794</url>
    </required_header>
    <id_info>
      <org_study_id>NCC-4123</org_study_id>
      <nct_id>NCT06033794</nct_id>
    </id_info>
    <brief_title>Applications of Fluorescence Imaging Guided Lymph Node Dissection and Fluorescence Angiography of Inferior Mesenteric Artery Assisted Left Colic Artery Preservation</brief_title>
    <official_title>Applications of Near-infrared Fluorescence Imaging Guided Lymph Node Dissection and Fluorescence Angiography of Inferior Mesenteric Artery Assisted Left Colic Artery Preservation: A Prospective Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</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>
        To investigate the accuracy of fluorescence angiography technique IMA classification and the&#xD;
        impact of lymph node mapping technique on the dissection of No. 253 lymph nodes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Multiple studies, including randomized controlled trials (RCTs), have demonstrated that lymph&#xD;
        node imaging techniques can effectively increase the number of harvested lymph nodes in&#xD;
        gastric and colorectal cancer surgeries . However, there remains a scarcity of research&#xD;
        specifically focused on the surgical procedure of fluorescent-guided clearance of No. 253&#xD;
        lymph nodes. Most existing studies have been retrospective analyses, and the need for&#xD;
        prospective studies is evident. Further clinical research is crucial to explore the&#xD;
        successful application of fluorescence lymph node imaging combined with indocyanine green&#xD;
        (ICG) fluorescence angiography and its multifunctional fusion. To address this gap,&#xD;
        investigators plan to conduct a randomized controlled trial comparing the outcomes between&#xD;
        the use of ICG Fluorescence lymph node Imaging combined with Fluorescence angiography (FIFA&#xD;
        group) and conventional techniques (non-ICG group) in laparoscopic rectal cancer surgery.&#xD;
        Specifically, investigators focus will be on the preservation of the left colic artery (LCA)&#xD;
        and the clearance of No. 253 lymph nodes. The primary objectives of our study are to simplify&#xD;
        surgical procedures, enhance surgical safety, and provide substantial evidence for the&#xD;
        further promotion and adoption of this technique.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>success rate of IMA fluorescence imaging</measure>
      <time_frame>From the beginning to the end of the surgery.</time_frame>
      <description>ICG solution was prepared at a concentration of 2.5 g/L. A dose of 0.05 mg-0.10 mg/kg body weight of ICG was administered intravenously through a peripheral or central vein. Before the injection of ICG, the fluorescence laparoscope was set to the original fluorescence mode to monitor the IMA region in real-time.Record the success or failure rate of IMA fluorescence imaging in the observation group. Classify the successful IMA fluorescence imaging results into four different types according to the Morro classification and calculate the proportion of each type in successful imaging.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Left colic artery retention rate</measure>
      <time_frame>From the beginning to the end of the surgery.</time_frame>
      <description>Recording whether the left colic artery is preserved during surger.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of IMA bleeding events</measure>
      <time_frame>From the beginning to the end of the surgery.</time_frame>
      <description>Document incidents of mesenteric artery or vein bleeding caused by vascular injury during surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>No.253 lymph node dissection time</measure>
      <time_frame>From the beginning to the end of the surgery.</time_frame>
      <description>Measured based on surgical videos.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Operation time</measure>
      <time_frame>From the beginning to the end of the surgery.</time_frame>
      <description>Data obtained from anesthesia records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative blood loss</measure>
      <time_frame>From the beginning to the end of the surgery.</time_frame>
      <description>Data obtained from anesthesia records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Protective ostomy rate</measure>
      <time_frame>From the beginning to the end of the surgery.</time_frame>
      <description>Data obtained from surgical records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complication rate within 30 days after operation</measure>
      <time_frame>within 30 days after operation.</time_frame>
      <description>According to the Clavien-Dindo classification system, complications were categorized into five grades. The postoperative status of each patient was recorded within 30 days, and the proportion of complications in each grade was calculated as a percentage of the total number of observations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of postoperative anal function urinary function within 30 days</measure>
      <time_frame>Assessment conducted once before surgery, on postoperative day 7, and on postoperative day 30.</time_frame>
      <description>Evaluation of Low Anterior Resection Syndrome (LARS) scale, assessed using the following scales at preoperative, postoperative day 7, and day 30. Scores range from 0 to 42, with lower scores indicating better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of residual urine volume in the bladder.</measure>
      <time_frame>On the day the catheter was removed after surgery.</time_frame>
      <description>Bladder residual urine volume was measured on the same day as catheter removal. A bladder residual urine volume of less than 50 ml was considered indicative of good bladder function, while a volume greater than or equal to 50 ml was considered indicative of urinary retention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arterial development time</measure>
      <time_frame>From the beginning to the end of the surgery.</time_frame>
      <description>Measured based on surgical videos.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Fluorescence</condition>
    <condition>Indocyanine Green</condition>
    <condition>Rectal Cancer Surgery</condition>
    <arm_group>
      <arm_group_label>Laparoscopic No. 253 lymph node dissection and preserving the LCA under fluorescence guidance.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Preoperatively, indoycine green fluorescent dye was injected into the anus to trace the No. 253 lymph nodes, and intraoperatively, arterial branching of the mesentery was performed by intravenous injection of fluorescent dye to preserve the left colic artery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Performing laparoscopic No. 253 lymph node dissection and preserving the LCA.</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Conventional laparoscopic approach for dissection of the No. 253 lymph nodes and preservation of the left colic artery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Fluorescence laparoscopic system</intervention_name>
      <description>Intraoperative fluorescence imaging was performed using the DPM-ENDOCAM-03 and DPM-LIGHT-03 fluorescence imaging system (manufactured by Digital Precision Medicine Technology Co., Ltd., Zhuhai, China). This system provides original fluorescence mode, color mode, and fusion mode, allowing real-time quantitative analysis of the fluorescence signals.</description>
      <arm_group_label>Laparoscopic No. 253 lymph node dissection and preserving the LCA under fluorescence guidance.</arm_group_label>
      <arm_group_label>Performing laparoscopic No. 253 lymph node dissection and preserving the LCA.</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged between 18 and 75 years&#xD;
  &#xD;
            -  Colonoscopic biopsy confirmed colorectal adenocarcinoma&#xD;
  &#xD;
            -  The tumor was located in the rectum or upper rectum, and the surgical method was Dxion&#xD;
  &#xD;
            -  No local complications before operation (no obstruction, incomplete obstruction, no&#xD;
               massive active bleeding, no perforation, abscess formation, no local invasion)&#xD;
  &#xD;
            -  Preoperative imaging diagnosis was cT1-4aNxM0&#xD;
  &#xD;
            -  The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the&#xD;
               requirements of surgery and anesthesia&#xD;
  &#xD;
            -  Sign the informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous surgical history of malignant colorectal tumors&#xD;
  &#xD;
            -  The surgical methods were combined abdominoperineal resection, Hartman operation and&#xD;
               ISR operation&#xD;
  &#xD;
            -  There are contraindication of laparoscopic surgery, such as severe cardiopulmonary&#xD;
               insufficiency&#xD;
  &#xD;
            -  Patients who have undergone multiple abdominal and pelvic surgeries or extensive&#xD;
               abdominal adhesion&#xD;
  &#xD;
            -  Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and&#xD;
               other emergency operations&#xD;
  &#xD;
            -  ASA grade ≥IV and/or ECOG physical status score ≥2 points&#xD;
  &#xD;
            -  Patients with severe liver and kidney function, cardiopulmonary function, coagulation&#xD;
               dysfunction or combined with serious underlying diseases can not tolerate surgery&#xD;
  &#xD;
            -  Have a history of serious mental illness&#xD;
  &#xD;
            -  Patients with uncontrolled infection before operation&#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_contact>
      <last_name>Jianqiang Tang, Dr.</last_name>
      <phone>+8613661090036</phone>
      <email>doc_tjq@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cancer Hospital Chinese Academy of Medical Sciences</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100021</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jianqiang Tang, Dr.</last_name>
        <phone>+8613661090026</phone>
        <email>doc_tjq@hotmail.com</email>
      </contact>
      <investigator>
        <last_name>Jianqiang Tang, Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
      <investigator_full_name>Jianqiang Tang</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <keyword>Left Colic Artery</keyword>
    <keyword>Fluorescence</keyword>
    <keyword>No. 253 lymph node</keyword>
    <keyword>Inferior mesenteric artery</keyword>
    <keyword>Indocyanine green</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033794
  org study id: NCC-4123
  nct id: NCT06033794
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To investigate the accuracy of fluorescence angiography technique IMA classification and the
        impact of lymph node mapping technique on the dissection of No. 253 lymph nodes.
  Multiple studies, including randomized controlled trials (RCTs), have demonstrated that lymph
        node imaging techniques can effectively increase the number of harvested lymph nodes in
        gastric and colorectal cancer surgeries . However, there remains a scarcity of research
        specifically focused on the surgical procedure of fluorescent-guided clearance of No. 253
        lymph nodes. Most existing studies have been retrospective analyses, and the need for
        prospective studies is evident. Further clinical research is crucial to explore the
        successful application of fluorescence lymph node imaging combined with indocyanine green
        (ICG) fluorescence angiography and its multifunctional fusion. To address this gap,
        investigators plan to conduct a randomized controlled trial comparing the outcomes between
        the use of ICG Fluorescence lymph node Imaging combined with Fluorescence angiography (FIFA
        group) and conventional techniques (non-ICG group) in laparoscopic rectal cancer surgery.
        Specifically, investigators focus will be on the preservation of the left colic artery (LCA)
        and the clearance of No. 253 lymph nodes. The primary objectives of our study are to simplify
        surgical procedures, enhance surgical safety, and provide substantial evidence for the
        further promotion and adoption of this technique.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: success rate of IMA fluorescence imaging
  time frame: From the beginning to the end of the surgery.
  description: ICG solution was prepared at a concentration of 2.5 g/L. A dose of 0.05 mg-0.10 mg/kg body weight of ICG was administered intravenously through a peripheral or central vein. Before the injection of ICG, the fluorescence laparoscope was set to the original fluorescence mode to monitor the IMA region in real-time.Record the success or failure rate of IMA fluorescence imaging in the observation group. Classify the successful IMA fluorescence imaging results into four different types according to the Morro classification and calculate the proportion of each type in successful imaging.
  measure: Left colic artery retention rate
  time frame: From the beginning to the end of the surgery.
  description: Recording whether the left colic artery is preserved during surger.
  measure: Incidence of IMA bleeding events
  time frame: From the beginning to the end of the surgery.
  description: Document incidents of mesenteric artery or vein bleeding caused by vascular injury during surgery.
  measure: No.253 lymph node dissection time
  time frame: From the beginning to the end of the surgery.
  description: Measured based on surgical videos.
  measure: Operation time
  time frame: From the beginning to the end of the surgery.
  description: Data obtained from anesthesia records.
  measure: Intraoperative blood loss
  time frame: From the beginning to the end of the surgery.
  description: Data obtained from anesthesia records.
  measure: Protective ostomy rate
  time frame: From the beginning to the end of the surgery.
  description: Data obtained from surgical records.
  measure: Complication rate within 30 days after operation
  time frame: within 30 days after operation.
  description: According to the Clavien-Dindo classification system, complications were categorized into five grades. The postoperative status of each patient was recorded within 30 days, and the proportion of complications in each grade was calculated as a percentage of the total number of observations.
  measure: Assessment of postoperative anal function urinary function within 30 days
  time frame: Assessment conducted once before surgery, on postoperative day 7, and on postoperative day 30.
  description: Evaluation of Low Anterior Resection Syndrome (LARS) scale, assessed using the following scales at preoperative, postoperative day 7, and day 30. Scores range from 0 to 42, with lower scores indicating better outcomes.
  measure: Measurement of residual urine volume in the bladder.
  time frame: On the day the catheter was removed after surgery.
  description: Bladder residual urine volume was measured on the same day as catheter removal. A bladder residual urine volume of less than 50 ml was considered indicative of good bladder function, while a volume greater than or equal to 50 ml was considered indicative of urinary retention.
  measure: Arterial development time
  time frame: From the beginning to the end of the surgery.
  description: Measured based on surgical videos.
  arm group label: Laparoscopic No. 253 lymph node dissection and preserving the LCA under fluorescence guidance.
  arm group type: Experimental
  description: Preoperatively, indoycine green fluorescent dye was injected into the anus to trace the No. 253 lymph nodes, and intraoperatively, arterial branching of the mesentery was performed by intravenous injection of fluorescent dye to preserve the left colic artery.
  arm group label: Performing laparoscopic No. 253 lymph node dissection and preserving the LCA.
  arm group type: Active Comparator
  description: Conventional laparoscopic approach for dissection of the No. 253 lymph nodes and preservation of the left colic artery.
  intervention type: Device
  intervention name: Fluorescence laparoscopic system
  description: Intraoperative fluorescence imaging was performed using the DPM-ENDOCAM-03 and DPM-LIGHT-03 fluorescence imaging system (manufactured by Digital Precision Medicine Technology Co., Ltd., Zhuhai, China). This system provides original fluorescence mode, color mode, and fusion mode, allowing real-time quantitative analysis of the fluorescence signals.
  arm group label: Laparoscopic No. 253 lymph node dissection and preserving the LCA under fluorescence guidance.
  arm group label: Performing laparoscopic No. 253 lymph node dissection and preserving the LCA.
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jianqiang Tang, Dr.
  phone: +8613661090036
  email: doc_tjq@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  investigator full name: Jianqiang Tang
  investigator title: Associate professor
  mesh term: Colic