<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/NCT03238573</url>
  </required_header>
  <id_info>
    <org_study_id>2017SDU-QILU-03</org_study_id>
    <nct_id>NCT03238573</nct_id>
  </id_info>
  <brief_title>The Real-time Optical Diagnosis Value of Optical Enhancement Endoscopy in Colorectal Sessile Serrated Adenomas/Polyps</brief_title>
  <official_title>The Real-time Optical Diagnosis Value of Optical Enhancement Endoscopy in Colorectal Sessile Serrated Adenomas/Polyps :A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      When a polyp is found, we begin to wash it and observe it with OE mode 1.Then,the endoscopist&#xD;
      gives a real-time optical diagnosis and the future surveillance interval.Finally,the polyp&#xD;
      will be resected for the biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When discovering a polyp, the endoscopist uses water to wash it.Then, the endoscopist starts&#xD;
      with i-scan 1 (OE mode 1) to observe the polyp closely .Nextly, the endoscopist give a&#xD;
      real-time optical diagnosis with the blind of the history of patient. Considering the other&#xD;
      polyps, the endoscopist gives a surveillance interval predictions according to the guide made&#xD;
      by USMSTF.The confidence of the real-time optical diagnosis is divided into high confidence&#xD;
      and low confidence.After the observation, the small and diminutive polyp will be resected and&#xD;
      have the blinded pathology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 19, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2019</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>Real-time diagnosis accuracy of optical enhancement in colorectal sessile serrated adenomas/polyps</measure>
    <time_frame>2years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Real-time diagnosis accuracy of optical enhancement in colorectal adenomas and hyperplastic polyps</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Colorectal Sessile Serrated Adenomas/Polyps</condition>
  <arm_group>
    <arm_group_label>optical enhancment endoscopy</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who experience an examination of coloscopy found polyps&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The high risk for colorectal cancer screening score&#xD;
&#xD;
          2. Patients with colorectal polyps reviewing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.Inflammatory bowel disease 2. Polyposis syndrome 3. A history of colorectal cancer&#xD;
             or surgical resection 4. Poor bowel preparation5.Not signing the informed consent&#xD;
             6.Severe cardiopulmonary function failure lesions, severe hypertension,&#xD;
             cerebrovascular disease, mental disorder and coma, pregnancy, lactation can't taking&#xD;
             the colonoscopy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Qilu Hospital, Shandong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yanqing Li, MD,PhD</last_name>
    <phone>86-531-82169236</phone>
    <email>liyanqing@sdu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Gastroenterology,Qilu Hospital,Shandong University</name>
      <address>
        <city>Jin'an</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanqing Li, MD,PhD</last_name>
      <phone>86-531-82169236</phone>
      <email>liyanqing@sdu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Erichsen R, Baron JA, Hamilton-Dutoit SJ, Snover DC, Torlakovic EE, Pedersen L, Froslev T, Vyberg M, Hamilton SR, Sorensen HT. Increased Risk of Colorectal Cancer Development Among Patients With Serrated Polyps. Gastroenterology. 2016 Apr;150(4):895-902.e5. doi: 10.1053/j.gastro.2015.11.046. Epub 2015 Dec 8.</citation>
    <PMID>26677986</PMID>
  </results_reference>
  <results_reference>
    <citation>IJspeert JE, Bastiaansen BA, van Leerdam ME, Meijer GA, van Eeden S, Sanduleanu S, Schoon EJ, Bisseling TM, Spaander MC, van Lelyveld N, Bargeman M, Wang J, Dekker E; Dutch Workgroup serrAted polypS &amp; Polyposis (WASP). Development and validation of the WASP classification system for optical diagnosis of adenomas, hyperplastic polyps and sessile serrated adenomas/polyps. Gut. 2016 Jun;65(6):963-70. doi: 10.1136/gutjnl-2014-308411. Epub 2015 Mar 9.</citation>
    <PMID>25753029</PMID>
  </results_reference>
  <results_reference>
    <citation>Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):844-857. doi: 10.1053/j.gastro.2012.06.001. Epub 2012 Jul 3. No abstract available.</citation>
    <PMID>22763141</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Yanqing Li</investigator_full_name>
    <investigator_title>Vice president of Qilu Hospital</investigator_title>
  </responsible_party>
  <keyword>Colorectal Sessile Serrated Adenomas/Polyps optical enhancement endoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Polyps</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03238573
org study id: 2017SDU-QILU-03
nct id: NCT03238573
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
When a polyp is found, we begin to wash it and observe it with OE mode 1.Then,the endoscopist
      gives a real-time optical diagnosis and the future surveillance interval.Finally,the polyp
      will be resected for the biopsy.
When discovering a polyp, the endoscopist uses water to wash it.Then, the endoscopist starts
      with i-scan 1 (OE mode 1) to observe the polyp closely .Nextly, the endoscopist give a
      real-time optical diagnosis with the blind of the history of patient. Considering the other
      polyps, the endoscopist gives a surveillance interval predictions according to the guide made
      by USMSTF.The confidence of the real-time optical diagnosis is divided into high confidence
      and low confidence.After the observation, the small and diminutive polyp will be resected and
      have the blinded pathology.
observational model: Cohort
time perspective: Prospective
measure: Real-time diagnosis accuracy of optical enhancement in colorectal sessile serrated adenomas/polyps
time frame: 2years
measure: Real-time diagnosis accuracy of optical enhancement in colorectal adenomas and hyperplastic polyps
time frame: 2 years
arm group label: optical enhancment endoscopy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Li, MD,PhD
role: Study Director
affiliation: Qilu Hospital, Shandong University
last name: Yanqing Li, MD,PhD
phone: 86-531-82169236
email: liyanqing@sdu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
citation: Erichsen R, Baron JA, Hamilton-Dutoit SJ, Snover DC, Torlakovic EE, Pedersen L, Froslev T, Vyberg M, Hamilton SR, Sorensen HT. Increased Risk of Colorectal Cancer Development Among Patients With Serrated Polyps. Gastroenterology. 2016 Apr;150(4):895-902.e5. doi: 10.1053/j.gastro.2015.11.046. Epub 2015 Dec 8.
PMID: 26677986
citation: IJspeert JE, Bastiaansen BA, van Leerdam ME, Meijer GA, van Eeden S, Sanduleanu S, Schoon EJ, Bisseling TM, Spaander MC, van Lelyveld N, Bargeman M, Wang J, Dekker E; Dutch Workgroup serrAted polypS & Polyposis (WASP). Development and validation of the WASP classification system for optical diagnosis of adenomas, hyperplastic polyps and sessile serrated adenomas/polyps. Gut. 2016 Jun;65(6):963-70. doi: 10.1136/gutjnl-2014-308411. Epub 2015 Mar 9.
PMID: 25753029
citation: Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):844-857. doi: 10.1053/j.gastro.2012.06.001. Epub 2012 Jul 3. No abstract available.
PMID: 22763141
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Yanqing Li
investigator title: Vice president of Qilu Hospital
mesh term: Adenoma
mesh term: Polyps
sharing ipd: No