<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/NCT03250780</url>
  </required_header>
  <id_info>
    <org_study_id>GA16/89362</org_study_id>
    <nct_id>NCT03250780</nct_id>
  </id_info>
  <brief_title>Chromoendoscopy in Inflammatory Bowel Disease</brief_title>
  <official_title>Chromoendoscopy With 0.03% Indigo-carmine Delivered Via a Foot Pump Compared With 0.2% Indigo-carmine Delivered Via Spray Catheter for Detecting Dysplasia in Patients Undergoing Surveillance in Inflammatory Bowel Disease. A Randomized Control Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Leeds Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Leeds Teaching Hospitals NHS Trust</source>
  <brief_summary>
    <textblock>
      Patients with longstanding ulcerative colitis (inflammatory bowel disease, IBD) have&#xD;
      increased risk of developing colorectal cancer (CRC) when compared with that of the general&#xD;
      population. Therefore patients with longstanding colitis undergo regular screening&#xD;
      colonoscopy at varied time intervals depending on their individual risk. This is thought to&#xD;
      detect early mucosal (interior bowel lining) abnormalities, known as dysplasia, which can&#xD;
      progress to CRC. Until recently, IBD surveillance has relied upon colonoscopy with multiple&#xD;
      (at least 33) random biopsies of the bowel lining to detect dysplasia, but now international&#xD;
      guidelines recommended a technique called chromoendoscopy.&#xD;
&#xD;
      Chromoendoscopy involves applying a dye, called indigo-carmine, to the bowel lining whilst&#xD;
      performing colonoscopy which highlights more subtle abnormalities, therefore increasing&#xD;
      dysplasia detection rate.&#xD;
&#xD;
      There is no standard international concentration of the dye spray used during&#xD;
      chromoendoscopy. Studies have used different concentrations of indigo-carmine dye ranging&#xD;
      from 0.1 to 0.4%. We have recently shown that 0.2% dye improves detection rates compared to&#xD;
      high definition white light. The recent international SCENIC guidelines suggest using 0.03%&#xD;
      indigo-carmine via a foot pump. However there are no trials comparing the two methods and no&#xD;
      previous trials have used the 0.03%. We therefore aim to perform a randomised control trial,&#xD;
      comparing 0.03% indigo-carmine dye versus 0.2% in detecting dysplasia in patients undergoing&#xD;
      surveillance colonoscopy in IBD. Any lesions seen will assessed using standard endoscopic&#xD;
      appearance but also using optical biopsy forceps to further characterise the lesion, then&#xD;
      manage the lesion as standard guidelines. We will also take two additional rectal biopsies,&#xD;
      which will be snap frozen in liquid nitrogen and then studied using Raman Spectroscopy, Infra&#xD;
      Red spectroscopy and electrochemical impedance to develop optical markers to identify&#xD;
      patients at higher risk of dysplasia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with at least low grade dysplasia detected by targeted biopsy using 0.2% indigo-carmine compared with 0.03% indigo-carmine.</measure>
    <time_frame>10 minutes</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Patients with extensive colitis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with extensive colitis, for at least 8-10 years, already on the surveillance programme or newly referred whilst attending their outpatients IBD clinic at Leeds Teaching Hospitals NHS Trust will be screened by one of the research doctors who will be performing the surveillance colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>indigo-carmine 0.2% using a spray catheter</intervention_name>
    <arm_group_label>Patients with extensive colitis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>0.03% using a foot pump</intervention_name>
    <arm_group_label>Patients with extensive colitis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) Patients with longstanding (more than 8 years of disease), extensive (extending&#xD;
             proximal to splenic flexure) colitis attending for surveillance colonoscopy. 2)&#xD;
             Patients aged over 18 years of age 3) Patients with Primary Sclerosing Cholangitis and&#xD;
             Inflammatory Bowel Disease colitis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) Pregnant 2) Unwilling or unable to give informed consent 3) Severe active colitis&#xD;
             4) Poor bowel preparation 5) Unable to reach the caecum&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Venkataraman Subramanian, MBBS, MRCP, MD</last_name>
    <email>venkat.subramanian@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Richard Lord, MBChB, MRCP</last_name>
    <email>richard.lord2@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <zip>LS1 3HE,</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>June 17, 2019</last_update_submitted>
  <last_update_submitted_qc>June 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03250780
org study id: GA16/89362
nct id: NCT03250780
lead sponsor: 
Patients with longstanding ulcerative colitis (inflammatory bowel disease, IBD) have
      increased risk of developing colorectal cancer (CRC) when compared with that of the general
      population. Therefore patients with longstanding colitis undergo regular screening
      colonoscopy at varied time intervals depending on their individual risk. This is thought to
      detect early mucosal (interior bowel lining) abnormalities, known as dysplasia, which can
      progress to CRC. Until recently, IBD surveillance has relied upon colonoscopy with multiple
      (at least 33) random biopsies of the bowel lining to detect dysplasia, but now international
      guidelines recommended a technique called chromoendoscopy.

      Chromoendoscopy involves applying a dye, called indigo-carmine, to the bowel lining whilst
      performing colonoscopy which highlights more subtle abnormalities, therefore increasing
      dysplasia detection rate.

      There is no standard international concentration of the dye spray used during
      chromoendoscopy. Studies have used different concentrations of indigo-carmine dye ranging
      from 0.1 to 0.4%. We have recently shown that 0.2% dye improves detection rates compared to
      high definition white light. The recent international SCENIC guidelines suggest using 0.03%
      indigo-carmine via a foot pump. However there are no trials comparing the two methods and no
      previous trials have used the 0.03%. We therefore aim to perform a randomised control trial,
      comparing 0.03% indigo-carmine dye versus 0.2% in detecting dysplasia in patients undergoing
      surveillance colonoscopy in IBD. Any lesions seen will assessed using standard endoscopic
      appearance but also using optical biopsy forceps to further characterise the lesion, then
      manage the lesion as standard guidelines. We will also take two additional rectal biopsies,
      which will be snap frozen in liquid nitrogen and then studied using Raman Spectroscopy, Infra
      Red spectroscopy and electrochemical impedance to develop optical markers to identify
      patients at higher risk of dysplasia.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of patients with at least low grade dysplasia detected by targeted biopsy using 0.2% indigo-carmine compared with 0.03% indigo-carmine.
time frame: 10 minutes
arm group label: Patients with extensive colitis
arm group type: Experimental
description: Patients with extensive colitis, for at least 8-10 years, already on the surveillance programme or newly referred whilst attending their outpatients IBD clinic at Leeds Teaching Hospitals NHS Trust will be screened by one of the research doctors who will be performing the surveillance colonoscopy.
intervention type: Procedure
intervention name: indigo-carmine 0.2% using a spray catheter
arm group label: Patients with extensive colitis
intervention type: Procedure
intervention name: 0.03% using a foot pump
arm group label: Patients with extensive colitis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Venkataraman Subramanian, MBBS, MRCP, MD
email: venkat.subramanian@nhs.net
last name: Richard Lord, MBChB, MRCP
email: richard.lord2@nhs.net
facility: 
status: Recruiting
country: United Kingdom
responsible party type: Sponsor
mesh term: Inflammatory Bowel Diseases