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/NCT06022978</url>
    </required_header>
    <id_info>
      <org_study_id>FXY-068</org_study_id>
      <nct_id>NCT06022978</nct_id>
    </id_info>
    <brief_title>Submucosal Saline Injection Followed by Endoscopic Ultrasound</brief_title>
    <acronym>EUS-SSI</acronym>
    <official_title>Submucosal Saline Injection Followed by Endoscopic Ultrasound Versus Endoscopic Ultrasound Only for Distinguishing Between T1a and T1b Esophageal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Zhejiang Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sichuan Cancer Hospital and Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shandong Cancer Hospital and Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xinqiao Hospital of Chongqing</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sir Run Run Shaw Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Second Affiliated Hospital of Shaanxi University of Chinese Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Sun Yat-sen University</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>
        Endoscopic ultrasound (EUS) is unsatisfactory in distinguishing between T1a and T1b stage&#xD;
        esophageal squamous cell carcinoma (ESCC). Consequently, the National Comprehensive Cancer&#xD;
        Network guidelines recommend endoscopic resection (ER) as a diagnostic tool for substaging T1&#xD;
        stage ESCC. However, as an invasive approach, diagnostic ER is not an optimal approach&#xD;
        especially for T1b cases as most of them might not be fully cured by ER. It is necessary to&#xD;
        develop reliable and less invasive methods to distinguish between T1a and T1b stage ESCC. In&#xD;
        our previous unicentral trial, we found that submucosal saline injection (SSI) significantly&#xD;
        improved the diagnostic accuracy of EUS in differentiating between T1a and T1b stage ESCC. It&#xD;
        can be used as an alternative to diagnostic ER for preoperative substaging T1 stage ESCC&#xD;
        cases in remote regions where few endoscopists are able to perform diagnostic ER. The use of&#xD;
        EUS and SSI would help T1b stage patients avoid invasive diagnostic ER.&#xD;
  &#xD;
        Therefore, we aim to conduct a multi-center clinical trail to examine whether SSI can improve&#xD;
        traditional EUS accuracy in distinguishing between T1a and T1b stage ESCC.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 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>Diagnostic</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Diagnostic accuracy for T1a and T1b staging</measure>
      <time_frame>Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days</time_frame>
      <description>The stages judged from EUS or EUS+SSI or BLI+ME/EUS+SSI will be compared with the pathological results after endoscopic or surgical resection. So the sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of the three groups for early esophageal cancer will be measured respectivly.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">432</enrollment>
    <condition>Esophageal Cancer</condition>
    <arm_group>
      <arm_group_label>EUS only</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The enrolled patients will accept ordinary EUS only.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>EUS+SSI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The enrolled patients will be accepted submucosal injection of saline（SSI）,then EUS will be performed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BLI+ME/EUS+SSI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The enrolled patients will be accepted ordinary endoscope using blue laser Imaging and magnified ensocope system(BLI+ME), firstly. If B3 type intra pillary capillary loops (IPCL) was observed, then the procedure would be finished (no EUS or EUS+SSI) . If B1 or B2 type IPCL was observed, then EUS+SSI would be performed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Submucosal Saline Injection</intervention_name>
      <description>Inject 3-5 mL of saline into the submucosa within 10 minutes using a single-use 22G mucosal needle. The puncture point is located 0.5 cm from the edgeof the lesion, and the saline injection is stopped when the esophageal mucosa is elevated by approximately 1 cm.</description>
      <arm_group_label>BLI+ME/EUS+SSI</arm_group_label>
      <arm_group_label>EUS+SSI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Blue laser Imaging and Magnifying Endoscopy</intervention_name>
      <description>It is a new system for image-enhanced endoscopy using laser light. By clicking a button on the endoscope only , endoscopists can electronically stain and magnify the digestive tract lesions. This system can help endoscopists observe leisons more clearly and improve diagnosic accuracy.</description>
      <arm_group_label>BLI+ME/EUS+SSI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-75 years old, no gender limited;&#xD;
  &#xD;
            -  Patients with esophageal squamous cell carcinoma who be confirmed by ordinary&#xD;
               endoscopy and pathologic biopsy;&#xD;
  &#xD;
            -  Patients who agree to accept endoscopic resection or surgical excision of the lesion&#xD;
               in esophagus;&#xD;
  &#xD;
            -  patients with normal cardio-pulmonary function and normal coagulative function,are&#xD;
               predicted to be tolerated anesthesia and surgery;&#xD;
  &#xD;
            -  patients who understand test purpose, volunteer to join these study and sign the&#xD;
               consent inform.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with stages of T2, T3, or T4 displayed by EUS;&#xD;
  &#xD;
            -  Patients who can't tolerate endoscopy and surgical treatment for various reasons;&#xD;
  &#xD;
            -  Patients who have distant metastasis, or multiple source of malignant tumors;&#xD;
  &#xD;
            -  Patients with blood coagulative disorder;&#xD;
  &#xD;
            -  Patients don't accept the endoscopic examination or surgical treatment;&#xD;
  &#xD;
            -  Patients with poor compliancy.&#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_official>
      <last_name>Jian-jun Li, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jian-jun Li, M.D.</last_name>
      <phone>86-2087342822</phone>
      <email>lijj@sysucc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cancer center, Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510080</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jian-jun Li, M.D.</last_name>
        <phone>86-2087343381</phone>
        <email>lijj@sysucc.org.cn</email>
      </contact>
      <investigator>
        <last_name>Jian-jun Li, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Jian-jun Li</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Submucosal Saline Injection</keyword>
    <keyword>Endoscopic Ultrasound</keyword>
    <keyword>Early Esophageal Cancer</keyword>
    <keyword>Staging</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Esophageal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
    </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/NCT06022978
  org study id: FXY-068
  nct id: NCT06022978
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Endoscopic ultrasound (EUS) is unsatisfactory in distinguishing between T1a and T1b stage
        esophageal squamous cell carcinoma (ESCC). Consequently, the National Comprehensive Cancer
        Network guidelines recommend endoscopic resection (ER) as a diagnostic tool for substaging T1
        stage ESCC. However, as an invasive approach, diagnostic ER is not an optimal approach
        especially for T1b cases as most of them might not be fully cured by ER. It is necessary to
        develop reliable and less invasive methods to distinguish between T1a and T1b stage ESCC. In
        our previous unicentral trial, we found that submucosal saline injection (SSI) significantly
        improved the diagnostic accuracy of EUS in differentiating between T1a and T1b stage ESCC. It
        can be used as an alternative to diagnostic ER for preoperative substaging T1 stage ESCC
        cases in remote regions where few endoscopists are able to perform diagnostic ER. The use of
        EUS and SSI would help T1b stage patients avoid invasive diagnostic ER.
  
        Therefore, we aim to conduct a multi-center clinical trail to examine whether SSI can improve
        traditional EUS accuracy in distinguishing between T1a and T1b stage ESCC.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Single (Participant)
  measure: Diagnostic accuracy for T1a and T1b staging
  time frame: Participants will be followed for the duration of hospital stay in order to accept endosopic or surgical resection , an expected average of 10 days
  description: The stages judged from EUS or EUS+SSI or BLI+ME/EUS+SSI will be compared with the pathological results after endoscopic or surgical resection. So the sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of the three groups for early esophageal cancer will be measured respectivly.
  arm group label: EUS only
  arm group type: No Intervention
  description: The enrolled patients will accept ordinary EUS only.
  arm group label: EUS+SSI
  arm group type: Experimental
  description: The enrolled patients will be accepted submucosal injection of saline（SSI）,then EUS will be performed.
  arm group label: BLI+ME/EUS+SSI
  arm group type: Experimental
  description: The enrolled patients will be accepted ordinary endoscope using blue laser Imaging and magnified ensocope system(BLI+ME), firstly. If B3 type intra pillary capillary loops (IPCL) was observed, then the procedure would be finished (no EUS or EUS+SSI) . If B1 or B2 type IPCL was observed, then EUS+SSI would be performed.
  intervention type: Procedure
  intervention name: Submucosal Saline Injection
  description: Inject 3-5 mL of saline into the submucosa within 10 minutes using a single-use 22G mucosal needle. The puncture point is located 0.5 cm from the edgeof the lesion, and the saline injection is stopped when the esophageal mucosa is elevated by approximately 1 cm.
  arm group label: BLI+ME/EUS+SSI
  arm group label: EUS+SSI
  intervention type: Procedure
  intervention name: Blue laser Imaging and Magnifying Endoscopy
  description: It is a new system for image-enhanced endoscopy using laser light. By clicking a button on the endoscope only , endoscopists can electronically stain and magnify the digestive tract lesions. This system can help endoscopists observe leisons more clearly and improve diagnosic accuracy.
  arm group label: BLI+ME/EUS+SSI
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jian-jun Li, M.D.
  role: Principal Investigator
  affiliation: Sun Yat-sen University
  last name: Jian-jun Li, M.D.
  phone: 86-2087342822
  email: lijj@sysucc.org.cn
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Jian-jun Li
  investigator title: Professor
  mesh term: Esophageal Neoplasms
  sharing ipd: Yes
  ipd info type: Study Protocol