<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/NCT02196402</url>
  </required_header>
  <id_info>
    <org_study_id>5/2014</org_study_id>
    <nct_id>NCT02196402</nct_id>
  </id_info>
  <brief_title>Narrow Band Imaging in the Prediction of Surveillance Intervals After Polypectomy in Community Practice: Ready for (a European) Prime Time</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Valduce Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Valduce Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several reports have suggested that an endoscopic diagnosis of adenoma, by means of narrow&#xD;
      band imaging (NBI), might allow the determination of polyp management and surveillance&#xD;
      interval, particularly in patients with diminutive polyps (&lt; 5mm), in which the advanced&#xD;
      histological features are uncommon and the prevalence of invasive cancer is negligible (1).&#xD;
      On this basis, the American Society of Gastrointestinal Endoscopy (ASGE) has set an&#xD;
      initiative evaluating the applicability of real-time endoscopic polyp assessment in clinical&#xD;
      practice (1), which states that:&#xD;
&#xD;
        1. for diminutive polyps to be resected and discarded without pathologic assessment,&#xD;
           endoscopic technology (when used with high confidence) used to determine histology of&#xD;
           polyps &lt; 5mm in size, when combined with the histopathologic assessment of polyps &gt;5 mm&#xD;
           in size, should provide a &gt; 90% agreement in assignment of post-polypectomy surveillance&#xD;
           intervals when compared to decisions based on pathology assessment of all identified&#xD;
           polyps.&#xD;
&#xD;
        2. In order for a technology to be used to guide the decision to leave suspected&#xD;
           rectosigmoid hyperplastic polyps &lt;5 mm in size in place (without resection), the&#xD;
           technology should provide &gt; 90% negative predictive value (when used with high&#xD;
           confidence) for adenomatous histology&#xD;
&#xD;
      This strategy could potentially exert a significant impact on colonoscopy practice, by&#xD;
      decreasing at some extent pathology-associated costs, although those related to histological&#xD;
      analysis of &gt;5mm polyps is maintained.&#xD;
&#xD;
      In a recent study performed in our Centre (2), we restricted the application of the resect&#xD;
      and discard strategy to patients with small or diminutive polyps only, achieving an&#xD;
      accordance between endoscopy-directed and histology-directed surveillance strategy of about&#xD;
      85% in both populations. This approach, where decisions on patient management are driven only&#xD;
      by the &quot;in vivo&quot; endoscopic assessment, provides on one hand a slightly lower accordance than&#xD;
      the threshold of 90% set by the PIVI, but on the other one it allows the complete spare of&#xD;
      pathology related costs, although for a smaller proportion of patients. Moreover we observed&#xD;
      a negative predictive value of 86% for the presence of adenoma within the diminutive polyps&#xD;
      cohort, although a separate analysis for left sided ones was not performed.&#xD;
&#xD;
      AIms of this single center, prospective, observational study:&#xD;
&#xD;
        1. To prospectively evaluate the accordance between the endoscopy-directed and&#xD;
           histology-directed surveillance strategies by applying the resect and discard strategy&#xD;
           for diminutive polyps according to the PIVI statements&#xD;
&#xD;
        2. To assess the economic impact of the resect and discard strategy when applied either&#xD;
           according to the PIVI statements or to restrictedly to subjects with diminutive polyps&#xD;
           only&#xD;
&#xD;
        3. To provide a temporary validation of diagnostic performances of the resect and discard&#xD;
           strategy for our group and the potential presence of a learning effect for the&#xD;
           methodology&#xD;
&#xD;
        4. Accordance between endoscopists' and nurses' categorization of adenomas according to&#xD;
           standardized criteria (see below)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>proportion of cases in which the accordance between the endoscopy-directed and histology-directed surveillance strategies by applying the resect and discard strategy for diminutive polyps according to the PIVI statements was observed</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">280</enrollment>
  <condition>Resect and Discard Strategies for Colonoscopy</condition>
  <arm_group>
    <arm_group_label>study population</arm_group_label>
    <description>Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy for routine indications (screening, symptoms, surveillance).&#xD;
Exclusion criteria:&#xD;
patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer&#xD;
patients with inadequate bowel preparation&#xD;
patients in which cecal intubation was not achieved or scheduled for partial examinations&#xD;
polyps could not be resected due to ongoing anticoagulation or could not be retrieved for pathologic assessment</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy for routine indications&#xD;
        (screening, symptoms, surveillance).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  patients with CRC history or hereditary polyposis syndromes or hereditary&#xD;
             non-polyposis colorectal cancer&#xD;
&#xD;
          -  patients with inadequate bowel preparation&#xD;
&#xD;
          -  patients in which cecal intubation was not achieved or scheduled for partial&#xD;
             examinations&#xD;
&#xD;
          -  polyps could not be resected due to ongoing anticoagulation or could not be retrieved&#xD;
             for pathologic assessment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy for routine&#xD;
             indications (screening, symptoms, surveillance).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  patients with CRC history or hereditary polyposis syndromes or hereditary&#xD;
             non-polyposis colorectal cancer&#xD;
&#xD;
          -  patients with inadequate bowel preparation&#xD;
&#xD;
          -  patients in which cecal intubation was not achieved or scheduled for partial&#xD;
             examinations&#xD;
&#xD;
          -  polyps could not be resected due to ongoing anticoagulation or could not be retrieved&#xD;
             for pathologic assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ospedale Valduce</name>
      <address>
        <city>Como</city>
        <zip>22100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Valduce Hospital</investigator_affiliation>
    <investigator_full_name>Arnaldo Amato</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <!-- 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/NCT02196402
org study id: 5/2014
nct id: NCT02196402
lead sponsor: 
has dmc: No
Several reports have suggested that an endoscopic diagnosis of adenoma, by means of narrow
      band imaging (NBI), might allow the determination of polyp management and surveillance
      interval, particularly in patients with diminutive polyps (< 5mm), in which the advanced
      histological features are uncommon and the prevalence of invasive cancer is negligible (1).
      On this basis, the American Society of Gastrointestinal Endoscopy (ASGE) has set an
      initiative evaluating the applicability of real-time endoscopic polyp assessment in clinical
      practice (1), which states that:

        1. for diminutive polyps to be resected and discarded without pathologic assessment,
           endoscopic technology (when used with high confidence) used to determine histology of
           polyps < 5mm in size, when combined with the histopathologic assessment of polyps >5 mm
           in size, should provide a > 90% agreement in assignment of post-polypectomy surveillance
           intervals when compared to decisions based on pathology assessment of all identified
           polyps.

        2. In order for a technology to be used to guide the decision to leave suspected
           rectosigmoid hyperplastic polyps <5 mm in size in place (without resection), the
           technology should provide > 90% negative predictive value (when used with high
           confidence) for adenomatous histology

      This strategy could potentially exert a significant impact on colonoscopy practice, by
      decreasing at some extent pathology-associated costs, although those related to histological
      analysis of >5mm polyps is maintained.

      In a recent study performed in our Centre (2), we restricted the application of the resect
      and discard strategy to patients with small or diminutive polyps only, achieving an
      accordance between endoscopy-directed and histology-directed surveillance strategy of about
      85% in both populations. This approach, where decisions on patient management are driven only
      by the "in vivo" endoscopic assessment, provides on one hand a slightly lower accordance than
      the threshold of 90% set by the PIVI, but on the other one it allows the complete spare of
      pathology related costs, although for a smaller proportion of patients. Moreover we observed
      a negative predictive value of 86% for the presence of adenoma within the diminutive polyps
      cohort, although a separate analysis for left sided ones was not performed.

      AIms of this single center, prospective, observational study:

        1. To prospectively evaluate the accordance between the endoscopy-directed and
           histology-directed surveillance strategies by applying the resect and discard strategy
           for diminutive polyps according to the PIVI statements

        2. To assess the economic impact of the resect and discard strategy when applied either
           according to the PIVI statements or to restrictedly to subjects with diminutive polyps
           only

        3. To provide a temporary validation of diagnostic performances of the resect and discard
           strategy for our group and the potential presence of a learning effect for the
           methodology

        4. Accordance between endoscopists' and nurses' categorization of adenomas according to
           standardized criteria (see below)
observational model: Cohort
time perspective: Prospective
measure: proportion of cases in which the accordance between the endoscopy-directed and histology-directed surveillance strategies by applying the resect and discard strategy for diminutive polyps according to the PIVI statements was observed
time frame: 4 months
arm group label: study population
description: Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy for routine indications (screening, symptoms, surveillance).
Exclusion criteria:
patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
patients with inadequate bowel preparation
patients in which cecal intubation was not achieved or scheduled for partial examinations
polyps could not be resected due to ongoing anticoagulation or could not be retrieved for pathologic assessment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Valduce Hospital
investigator full name: Arnaldo Amato
investigator title: MD