<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/NCT04464135</url>
  </required_header>
  <id_info>
    <org_study_id>KY20200706-3</org_study_id>
    <nct_id>NCT04464135</nct_id>
  </id_info>
  <brief_title>Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Colonoscopy</brief_title>
  <official_title>Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Screening and Surveillance Colonoscopy: a Multi-centered, Randomized Controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</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>
      Our previous study (Am. J. Gastroenterol. 2017 04;112(4)) showed that water exchange (WE)&#xD;
      colonoscopy was able to increase the detection of flat adenomas as well as overall ADR. We&#xD;
      hypothesized that WE based whole-colon acetic acid（AA） staining might be useful to improve&#xD;
      the detection of flat lesions compared with WE alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Water exchange colonoscopy was performed as described previously (Am. J. Gastroenterol. 2017&#xD;
      04;112(4)). Patients were randomly allocated to WE group or WE+AA group. In WE+AA group,&#xD;
      water containing 1% of AA was used during insertion of colonoscopy instead of water alone. A&#xD;
      bottle of 20ml pure AA was placed abutting the water pump, which make it possible to keep&#xD;
      patients blinded to group allocation. Endoscopist using a high-definition wide-angle Olympus&#xD;
      or Fujinum colonoscope performed all of the colonoscopies, with a withdrawal time of at least&#xD;
      6 min. The observation was initially performed without the assistance of cap or the use of&#xD;
      magnification or electronic staining (NBI, BLI, LCI or AFI et al.). Scopolamine butylbromide&#xD;
      or glucogon was not routinely administrated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 15, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 15, 2021</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>Number of flat polyps per patient</measure>
    <time_frame>9 months</time_frame>
    <description>average numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall ADR</measure>
    <time_frame>9 months</time_frame>
    <description>Adenoma detection rate, defined as the proportion of subjects with at least one adenoma of any size, in each group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Advanced ADR</measure>
    <time_frame>9 months</time_frame>
    <description>Advanced adenoma detection rate. Advanced adenoma: any with 3 or more adenomas of any size, 1 or more large adenomas 1 cm, or 1 or more adenomas with villous architecture or highgrade dysplasia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SSA/P detection rate</measure>
    <time_frame>9 months</time_frame>
    <description>SSA/P detection rate, defined as the proportion of subjects with at least one sessile serrated adenoma/polyp (SSA/P) of any size, in each group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flat neoplasms located in proximal colon</measure>
    <time_frame>9 months</time_frame>
    <description>Low-grade adenoma, adenoma with villous components, high-grade adenoma, noninvasive carcinoma, and invasive carcinoma in proximal colon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>9 months</time_frame>
    <description>the rate of bleeding and perforation during colonoscopy procedure and abdominal pain, diarrhea, hematochezia and change of defecation habit Within one week.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Adenoma Colon</condition>
  <arm_group>
    <arm_group_label>WE+AA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Water containing 1% of AA was used during insertion of colonoscopy using water exchange method.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WE group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Water exchange colonoscopy was used for standard screening or surveillance colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acetic acid staining</intervention_name>
    <description>The water exchange colonoscopy is used during insertion procedure, in which the water contains 1% acetic acid, and the liquid is absorbed during the withdrawal process for observation.</description>
    <arm_group_label>WE+AA group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water exchange colonoscopy</intervention_name>
    <description>The water exchange colonoscopy is used during insertion procedure, and the liquid is absorbed during the withdrawal process for observation.</description>
    <arm_group_label>WE group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 40-70&#xD;
&#xD;
          -  Undergoing colonoscopy after standard bowel preparation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known familial polyposis&#xD;
&#xD;
          -  Small amount of feces or semi-solid stool in last rectal effluent&#xD;
&#xD;
          -  Inflammatory Bowel Disease&#xD;
&#xD;
          -  Lactated or pregnant women&#xD;
&#xD;
          -  Unable to provide informed content&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanglin Pan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xijing Hospital of Digestive Diseases</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gui Ren, MD</last_name>
    <phone>+86298477136</phone>
    <email>renguigz@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yanglin Pan, MD</last_name>
    <phone>+862984771536</phone>
    <email>yanglinpan@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Gastroenterology, Second Affiliated Hospital, Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaojun Huang, MD</last_name>
      <phone>+8609318942279</phone>
      <email>haungxj62@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoying Zhang, MD</last_name>
      <phone>+8613116950266</phone>
      <email>13116950266@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Gastroenterology, Huaihe Hospital of Henan University</name>
      <address>
        <city>Kaifeng</city>
        <state>Henan</state>
        <zip>475000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianghai Zhao, MD</last_name>
      <phone>+8615191903630</phone>
      <email>493109907@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Gastroenterology, Shaanxi Second People's Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710005</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Limei Wang, MD</last_name>
      <phone>+8615291680602</phone>
      <email>15291680602@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Shibagaki K, Amano Y, Ishimura N, Yuki T, Taniguchi H, Fujita H, Kobayashi K, Kinoshita Y. Magnification endoscopy with acetic acid enhancement and a narrow-band imaging system for pit pattern diagnosis of colorectal neoplasms. J Clin Gastroenterol. 2015 Apr;49(4):306-12. doi: 10.1097/MCG.0000000000000148.</citation>
    <PMID>24804989</PMID>
  </reference>
  <results_reference>
    <citation>Jia H, Pan Y, Guo X, Zhao L, Wang X, Zhang L, Dong T, Luo H, Ge Z, Liu J, Hao J, Yao P, Zhang Y, Ren H, Zhou W, Guo Y, Zhang W, Chen X, Sun D, Yang X, Kang X, Liu N, Liu Z, Leung F, Wu K, Fan D. Water Exchange Method Significantly Improves Adenoma Detection Rate: A Multicenter, Randomized Controlled Trial. Am J Gastroenterol. 2017 Apr;112(4):568-576. doi: 10.1038/ajg.2016.501. Epub 2016 Dec 6.</citation>
    <PMID>27922025</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.</citation>
    <PMID>30738046</PMID>
  </results_reference>
  <results_reference>
    <citation>Desai M, Sanchez-Yague A, Choudhary A, Pervez A, Gupta N, Vennalaganti P, Vennelaganti S, Fugazza A, Repici A, Hassan C, Sharma P. Impact of cap-assisted colonoscopy on detection of proximal colon adenomas: systematic review and meta-analysis. Gastrointest Endosc. 2017 Aug;86(2):274-281.e3. doi: 10.1016/j.gie.2017.03.1524. Epub 2017 Mar 29.</citation>
    <PMID>28365356</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Yanglin Pan</investigator_full_name>
    <investigator_title>Associated professor</investigator_title>
  </responsible_party>
  <keyword>Water exchange colonoscopy</keyword>
  <keyword>Flat Polyps</keyword>
  <keyword>Acetic Acid Staining</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetic Acid</mesh_term>
    <mesh_term>Retinol acetate</mesh_term>
  </intervention_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/NCT04464135
org study id: KY20200706-3
nct id: NCT04464135
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Our previous study (Am. J. Gastroenterol. 2017 04;112(4)) showed that water exchange (WE)
      colonoscopy was able to increase the detection of flat adenomas as well as overall ADR. We
      hypothesized that WE based whole-colon acetic acid（AA） staining might be useful to improve
      the detection of flat lesions compared with WE alone.
Water exchange colonoscopy was performed as described previously (Am. J. Gastroenterol. 2017
      04;112(4)). Patients were randomly allocated to WE group or WE+AA group. In WE+AA group,
      water containing 1% of AA was used during insertion of colonoscopy instead of water alone. A
      bottle of 20ml pure AA was placed abutting the water pump, which make it possible to keep
      patients blinded to group allocation. Endoscopist using a high-definition wide-angle Olympus
      or Fujinum colonoscope performed all of the colonoscopies, with a withdrawal time of at least
      6 min. The observation was initially performed without the assistance of cap or the use of
      magnification or electronic staining (NBI, BLI, LCI or AFI et al.). Scopolamine butylbromide
      or glucogon was not routinely administrated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Number of flat polyps per patient
time frame: 9 months
description: average numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient
measure: Overall ADR
time frame: 9 months
description: Adenoma detection rate, defined as the proportion of subjects with at least one adenoma of any size, in each group.
measure: Advanced ADR
time frame: 9 months
description: Advanced adenoma detection rate. Advanced adenoma: any with 3 or more adenomas of any size, 1 or more large adenomas 1 cm, or 1 or more adenomas with villous architecture or highgrade dysplasia.
measure: SSA/P detection rate
time frame: 9 months
description: SSA/P detection rate, defined as the proportion of subjects with at least one sessile serrated adenoma/polyp (SSA/P) of any size, in each group.
measure: Flat neoplasms located in proximal colon
time frame: 9 months
description: Low-grade adenoma, adenoma with villous components, high-grade adenoma, noninvasive carcinoma, and invasive carcinoma in proximal colon
measure: Adverse events
time frame: 9 months
description: the rate of bleeding and perforation during colonoscopy procedure and abdominal pain, diarrhea, hematochezia and change of defecation habit Within one week.
arm group label: WE+AA group
arm group type: Experimental
description: Water containing 1% of AA was used during insertion of colonoscopy using water exchange method.
arm group label: WE group
arm group type: Active Comparator
description: Water exchange colonoscopy was used for standard screening or surveillance colonoscopy.
intervention type: Other
intervention name: acetic acid staining
description: The water exchange colonoscopy is used during insertion procedure, in which the water contains 1% acetic acid, and the liquid is absorbed during the withdrawal process for observation.
arm group label: WE+AA group
intervention type: Other
intervention name: Water exchange colonoscopy
description: The water exchange colonoscopy is used during insertion procedure, and the liquid is absorbed during the withdrawal process for observation.
arm group label: WE group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yanglin Pan, MD
role: Principal Investigator
affiliation: Xijing Hospital of Digestive Diseases
last name: Gui Ren, MD
phone: +86298477136
email: renguigz@hotmail.com
last name: Yanglin Pan, MD
phone: +862984771536
email: yanglinpan@hotmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
citation: Shibagaki K, Amano Y, Ishimura N, Yuki T, Taniguchi H, Fujita H, Kobayashi K, Kinoshita Y. Magnification endoscopy with acetic acid enhancement and a narrow-band imaging system for pit pattern diagnosis of colorectal neoplasms. J Clin Gastroenterol. 2015 Apr;49(4):306-12. doi: 10.1097/MCG.0000000000000148.
PMID: 24804989
citation: Jia H, Pan Y, Guo X, Zhao L, Wang X, Zhang L, Dong T, Luo H, Ge Z, Liu J, Hao J, Yao P, Zhang Y, Ren H, Zhou W, Guo Y, Zhang W, Chen X, Sun D, Yang X, Kang X, Liu N, Liu Z, Leung F, Wu K, Fan D. Water Exchange Method Significantly Improves Adenoma Detection Rate: A Multicenter, Randomized Controlled Trial. Am J Gastroenterol. 2017 Apr;112(4):568-576. doi: 10.1038/ajg.2016.501. Epub 2016 Dec 6.
PMID: 27922025
citation: Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
PMID: 30738046
citation: Desai M, Sanchez-Yague A, Choudhary A, Pervez A, Gupta N, Vennalaganti P, Vennelaganti S, Fugazza A, Repici A, Hassan C, Sharma P. Impact of cap-assisted colonoscopy on detection of proximal colon adenomas: systematic review and meta-analysis. Gastrointest Endosc. 2017 Aug;86(2):274-281.e3. doi: 10.1016/j.gie.2017.03.1524. Epub 2017 Mar 29.
PMID: 28365356
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Yanglin Pan
investigator title: Associated professor
mesh term: Adenoma
mesh term: Acetic Acid
mesh term: Retinol acetate
sharing ipd: No