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/NCT06002906</url>
    </required_header>
    <id_info>
      <org_study_id>20-5008</org_study_id>
      <nct_id>NCT06002906</nct_id>
    </id_info>
    <brief_title>The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery.</brief_title>
    <official_title>The Use of Indocyanine Green to Visualize Blood Flow to the Gastrojejunostomy During Bariatric Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Health Network, Toronto</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Stryker Endoscopy</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>University Health Network, Toronto</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an interventional pilot study aimed to evaluate the use of NIF imaging as an&#xD;
        intraoperative aid to assess the anastomotic blood flow to the gastric pouch and&#xD;
        gastrojejunostomy during Roux-en-Y gastric bypass surgery and to determine its long-term&#xD;
        impact on the rate of marginal ulceration, leaks and stricture.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to examine intraoperative usefulness of near-infrared light&#xD;
        fluorescence imaging with a contrast agent called indocyanine green to improve visualization&#xD;
        of blood flow to a surgical connection between the small intestine and stomach&#xD;
        (gastrojejunostomy) in patients undergoing gastric bypass surgery. ICG will be given prior to&#xD;
        and after making the gastrojejunostomy to examine blood flow and then a subjective perfusion&#xD;
        score will be given by the surgeon and assistant during the surgery.&#xD;
  &#xD;
        Patients will be recruited before the laparoscopic Roux-en-Y gastric bypass surgery and the&#xD;
        study data will be collected prospectively through standard bariatric follow up visits up to&#xD;
        2 years. A mid-term analysis of the procedure and patient outcomes will be performed for&#xD;
        quality assurance purposes when half the study patients have undergone intraoperative ICG&#xD;
        use. The ICG will be not given if a patient is allergic to sodium iodide or has a history of&#xD;
        allergy to iodides because of the risk of a severe allergic reaction.&#xD;
  &#xD;
        Participants will be assigned an identifying number to protect confidentiality. Descriptive&#xD;
        univariate and multivariate statistical analysis will be performed on all patients satisfying&#xD;
        the study's inclusion criteria.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 25, 2023</start_date>
    <completion_date type="Anticipated">January 2026</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>Phase 4</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.</measure>
      <time_frame>2 years</time_frame>
      <description>ICG imaging will be performed intraoperatively using an existing imaging system (1688 Advanced Imaging Modalities (AIM) System (Stryker)), and the images will be assessed by the operating surgeons and as well as by an independent surgeon (part of the study team, independent from the surgery) postoperatively using a scoring system. Images will also be analyzed postoperatively to obtain an objective score based on fluorescence intensity. The applicability of ICG imaging in the context of RYGB will be assessed based on the inter-observer agreement.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The impact of ICG imaging on the rate of marginal ulcer and other complications (leaks, strictures).</measure>
      <time_frame>2 years</time_frame>
      <description>The patients in the Toronto Western Hospital as per the standard care of bariatric program will be followed for up to 2 years following surgery to identify any complications including marginal ulcerations. Data is collected prospectively at the study site. We will also use the data from the scoring system and determine the correlation between the scores and the occurrence of marginal ulcers and any other complications (leaks, strictures).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the safety of routine use of NIF imaging using ICG in bariatric patients.</measure>
      <time_frame>2 Years</time_frame>
      <description>Based on the literature, we do not anticipate intra-operative or injection-related adverse effects. Nevertheless, we will use our existing database that collects postoperative outcomes for 30 days to identify adverse events, if any.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Ulcer, Gastric</condition>
    <condition>Obesity, Morbid</condition>
    <arm_group>
      <arm_group_label>Interventional group (with drug)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Indocyanine green</intervention_name>
      <description>Indocyanine green (ICG) is a safe, sterile, water-soluble molecule that binds to plasma proteins and can be injected intravenously. ICG will be injected intravenously based on the patient's weight prior to and after making the GJ anastomosis and a 10 mL bolus of normal saline will be immediately followed the injection of indocyanine green by an anesthesiologist. A subjective score of 1-5 for perfusion will be assigned by operating surgeons. The RYGB will then be completed by the operating surgeon in their routine fashion.</description>
      <arm_group_label>Interventional group (with drug)</arm_group_label>
      <other_name>SPY AGENT GREEN</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Stryker 1688 AIM system</intervention_name>
      <description>The Stryker 1688 AIM system used during laparoscopic surgery which is sensitive in the visible and infrared spectrum. ICG (SPY AGENT™ GREEN) is used with the SPY mode in the Stryker 1688 AIM fluorescence imaging system to perform intraoperative fluorescence angiography.</description>
      <arm_group_label>Interventional group (with drug)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Capacity to provide informed consent.&#xD;
  &#xD;
            -  Over the Age of 18.&#xD;
  &#xD;
            -  Eligible for bariatric surgery in Ontario and deemed an appropriate candidate for RYGB&#xD;
               surgery by the bariatric program.&#xD;
  &#xD;
            -  Commit to follow-up within the bariatric program, including behavioral and dietary&#xD;
               modifications designed to aid in sustained weight-loss.&#xD;
  &#xD;
            -  Treatment of marginal ulcer with the revisional surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not willing to participate in study&#xD;
  &#xD;
            -  Contraindication to, or not planned to undergo RYGB&#xD;
  &#xD;
            -  Known allergy to indocyanine green or Sodium Iodide&#xD;
  &#xD;
            -  Are you pregnant or are you planning to get pregnant in next two years&#xD;
  &#xD;
            -  Ongoing substance abuse or active smoking&#xD;
  &#xD;
            -  Bleeding diathesis or Coagulopathy&#xD;
  &#xD;
            -  Unwilling to take PPI medication Post operatively&#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>Allan Okrainec</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Health Network, Toronto</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Allan Okrainec, MDCM, MHPE</last_name>
      <phone>4166035224</phone>
      <email>allan.okrainec@uhn.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Priya Sharma</last_name>
      <email>priya.sharma@uhn.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Toronto Western Hospital, University Health Network</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5T2S8</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dr. Allan Okrainec, MDCM, MHPE</last_name>
        <phone>4166035224</phone>
        <email>allan.okrainec@uhn.ca</email>
      </contact>
      <contact_backup>
        <last_name>Priya Sharma</last_name>
        <email>priya.sharma@uhn.ca</email>
      </contact_backup>
      <investigator>
        <last_name>Dr. Allan Okrainec, MDCM, MHPE</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dr. Timothy Jackson, MD, MPH</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dr. Andras B. Fecso, MD PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
      <investigator_full_name>Allan Okrainec</investigator_full_name>
      <investigator_title>MD, MHPE, FACS, FRCSC</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Ulcer</mesh_term>
      <mesh_term>Obesity, Morbid</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06002906
  org study id: 20-5008
  nct id: NCT06002906
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: Yes
  is us export: Yes
  This is an interventional pilot study aimed to evaluate the use of NIF imaging as an
        intraoperative aid to assess the anastomotic blood flow to the gastric pouch and
        gastrojejunostomy during Roux-en-Y gastric bypass surgery and to determine its long-term
        impact on the rate of marginal ulceration, leaks and stricture.
  The purpose of this study is to examine intraoperative usefulness of near-infrared light
        fluorescence imaging with a contrast agent called indocyanine green to improve visualization
        of blood flow to a surgical connection between the small intestine and stomach
        (gastrojejunostomy) in patients undergoing gastric bypass surgery. ICG will be given prior to
        and after making the gastrojejunostomy to examine blood flow and then a subjective perfusion
        score will be given by the surgeon and assistant during the surgery.
  
        Patients will be recruited before the laparoscopic Roux-en-Y gastric bypass surgery and the
        study data will be collected prospectively through standard bariatric follow up visits up to
        2 years. A mid-term analysis of the procedure and patient outcomes will be performed for
        quality assurance purposes when half the study patients have undergone intraoperative ICG
        use. The ICG will be not given if a patient is allergic to sodium iodide or has a history of
        allergy to iodides because of the risk of a severe allergic reaction.
  
        Participants will be assigned an identifying number to protect confidentiality. Descriptive
        univariate and multivariate statistical analysis will be performed on all patients satisfying
        the study's inclusion criteria.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: The applicability of ICG as an indicator of anastomotic blood flow during bariatric surgery.
  time frame: 2 years
  description: ICG imaging will be performed intraoperatively using an existing imaging system (1688 Advanced Imaging Modalities (AIM) System (Stryker)), and the images will be assessed by the operating surgeons and as well as by an independent surgeon (part of the study team, independent from the surgery) postoperatively using a scoring system. Images will also be analyzed postoperatively to obtain an objective score based on fluorescence intensity. The applicability of ICG imaging in the context of RYGB will be assessed based on the inter-observer agreement.
  measure: The impact of ICG imaging on the rate of marginal ulcer and other complications (leaks, strictures).
  time frame: 2 years
  description: The patients in the Toronto Western Hospital as per the standard care of bariatric program will be followed for up to 2 years following surgery to identify any complications including marginal ulcerations. Data is collected prospectively at the study site. We will also use the data from the scoring system and determine the correlation between the scores and the occurrence of marginal ulcers and any other complications (leaks, strictures).
  measure: To evaluate the safety of routine use of NIF imaging using ICG in bariatric patients.
  time frame: 2 Years
  description: Based on the literature, we do not anticipate intra-operative or injection-related adverse effects. Nevertheless, we will use our existing database that collects postoperative outcomes for 30 days to identify adverse events, if any.
  arm group label: Interventional group (with drug)
  arm group type: Experimental
  description: The interventional group will receive indocyanine green during bariatric surgery inside the operating room before and after making the gastrojejunostomy.
  intervention type: Drug
  intervention name: Indocyanine green
  description: Indocyanine green (ICG) is a safe, sterile, water-soluble molecule that binds to plasma proteins and can be injected intravenously. ICG will be injected intravenously based on the patient's weight prior to and after making the GJ anastomosis and a 10 mL bolus of normal saline will be immediately followed the injection of indocyanine green by an anesthesiologist. A subjective score of 1-5 for perfusion will be assigned by operating surgeons. The RYGB will then be completed by the operating surgeon in their routine fashion.
  arm group label: Interventional group (with drug)
  other name: SPY AGENT GREEN
  intervention type: Device
  intervention name: Stryker 1688 AIM system
  description: The Stryker 1688 AIM system used during laparoscopic surgery which is sensitive in the visible and infrared spectrum. ICG (SPY AGENT™ GREEN) is used with the SPY mode in the Stryker 1688 AIM fluorescence imaging system to perform intraoperative fluorescence angiography.
  arm group label: Interventional group (with drug)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Allan Okrainec
  role: Principal Investigator
  affiliation: University Health Network, Toronto
  last name: Allan Okrainec, MDCM, MHPE
  phone: 4166035224
  email: allan.okrainec@uhn.ca
  last name: Priya Sharma
  email: priya.sharma@uhn.ca
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University Health Network, Toronto
  investigator full name: Allan Okrainec
  investigator title: MD, MHPE, FACS, FRCSC
  mesh term: Stomach Ulcer
  mesh term: Obesity, Morbid
  sharing ipd: No