<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/NCT03039309</url>
  </required_header>
  <id_info>
    <org_study_id>PHT/2016/45</org_study_id>
    <nct_id>NCT03039309</nct_id>
  </id_info>
  <brief_title>Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom</brief_title>
  <acronym>ESDUK</acronym>
  <official_title>Endoscopic Submucosal Dissection in the Treatment of Early Gastrointestinal Neoplasia: A UK Cohort Study to Assess Effectiveness and Safety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Portsmouth Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Portsmouth Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of&#xD;
      early gastrointestinal neoplasia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data will be collected from participating centres on en bloc resection, curative resection,&#xD;
      R0 resection and complications/adverse events over a 2 year follow up period.&#xD;
&#xD;
      Demographic details on the patients included in the study will be captured alongside details&#xD;
      on the size and location of their early gastrointestinal dysplastic/neoplastic lesions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 5, 2016</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Curative resection rate</measure>
    <time_frame>2 years</time_frame>
    <description>% of successful resections free of disease at follow up endoscopy by the end of the follow up period (2 years)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>En bloc resection rate</measure>
    <time_frame>At the time of procedure</time_frame>
    <description>% of en bloc resections obtained at the time of initial endoscopic submucosal dissection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rates</measure>
    <time_frame>28 days post procedure</time_frame>
    <description>% of complications noted within 28 days following endoscopic submucosal dissection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rates</measure>
    <time_frame>2 years</time_frame>
    <description>% of patients alive at the end of the 2 year follow up</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Endoscopic Submucosal Dissection</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Submucosal Dissection</intervention_name>
    <description>Endoscopic submucosal dissection is an endoscopic resection technique that utilises an endoscopic knife to remove lesions within the gastrointestinal tract in an en bloc fashion.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing endoscopic submucosal dissection for early gastrointestinal neoplasia&#xD;
        (e.g colorectal/gastric/oesophageal) in tertiary referral centres in the UK&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female, aged 18 years or above undergoing endoscopic submucosal dissection&#xD;
&#xD;
          -  Participant is able to give informed consent for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Patients unable to give informed consent&#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>Prof Pradeep Bhandari, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Portsmouth Hospitals NHS Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Prof Pradeep Bhandari, MBBS, MD</last_name>
    <phone>02392286000</phone>
    <phone_ext>5852</phone_ext>
    <email>pradeep.bhandari@porthosp.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sharmila Subramaniam, MBBS</last_name>
    <phone>02392286000</phone>
    <phone_ext>5852</phone_ext>
    <email>Sharmila.Subramaniam@porthosp.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Portsmputh Hospitals NHS Trust</name>
      <address>
        <city>Portsmouth</city>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alice Mortlock</last_name>
      <phone>+2392 286000</phone>
      <phone_ext>3774</phone_ext>
      <email>alice.mortlock@porthosp.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Linda Harndahl</last_name>
      <phone>+2392 286000</phone>
      <email>linda.harndahl@porthosp.nhs.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Pradeep Bhandari, MBBS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endoscopic Submucosal Dissection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03039309
org study id: PHT/2016/45
nct id: NCT03039309
lead sponsor: 
has dmc: No
Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of
      early gastrointestinal neoplasia.
Data will be collected from participating centres on en bloc resection, curative resection,
      R0 resection and complications/adverse events over a 2 year follow up period.

      Demographic details on the patients included in the study will be captured alongside details
      on the size and location of their early gastrointestinal dysplastic/neoplastic lesions.
observational model: Cohort
time perspective: Prospective
measure: Curative resection rate
time frame: 2 years
description: % of successful resections free of disease at follow up endoscopy by the end of the follow up period (2 years)
measure: En bloc resection rate
time frame: At the time of procedure
description: % of en bloc resections obtained at the time of initial endoscopic submucosal dissection
measure: Complication rates
time frame: 28 days post procedure
description: % of complications noted within 28 days following endoscopic submucosal dissection
measure: Mortality rates
time frame: 2 years
description: % of patients alive at the end of the 2 year follow up
intervention type: Procedure
intervention name: Endoscopic Submucosal Dissection
description: Endoscopic submucosal dissection is an endoscopic resection technique that utilises an endoscopic knife to remove lesions within the gastrointestinal tract in an en bloc fashion.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Prof Pradeep Bhandari, MBBS, MD
role: Principal Investigator
affiliation: Portsmouth Hospitals NHS Trust
last name: Prof Pradeep Bhandari, MBBS, MD
phone: 02392286000
phone ext: 5852
email: pradeep.bhandari@porthosp.nhs.uk
last name: Sharmila Subramaniam, MBBS
phone: 02392286000
phone ext: 5852
email: Sharmila.Subramaniam@porthosp.nhs.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: Undecided