<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/NCT03781648</url>
  </required_header>
  <id_info>
    <org_study_id>PLA GH-water exchange-ADR</org_study_id>
    <nct_id>NCT03781648</nct_id>
  </id_info>
  <brief_title>Water Exchange With Narrow Band Imaging on Adenoma Detection</brief_title>
  <acronym>NBI; ADR; WE</acronym>
  <official_title>PLA Army General Hospital of Beijing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuqi He</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>General Hospital of Beijing PLA Military Region</source>
  <oversight_info>
    <has_dmc>No</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>
      Colorectal cancer remains the third most common cause of death from cancer worldwide. The&#xD;
      adenoma detection rate is correlated with quality of colonoscopy and risk of postcolonoscopy&#xD;
      CRC. Low quality of bowel preparation with fecal residue and brown liquid in the colon may&#xD;
      lower the adenoma detection rate (ADR). Optimal bowel preparation and novel approaches for&#xD;
      colonoscopy increases the effectiveness of colonoscopic examination to improve ADR are&#xD;
      desirable. Water exchange, which significantly increased colon cleanliness both in the right&#xD;
      colon and the entire colon, is characterized by insertion to the cecum in clear water in lieu&#xD;
      of gas insufflations. Water exchange led to an increase in ADR, particularly for the&#xD;
      improvement in the right colon, providing adequate bowel preparation.&#xD;
&#xD;
      NBI is an innovative imaging technology which efficiency for the early detection of&#xD;
      superficial cancers in the head and neck region and the esophagus had been reported&#xD;
      previously. In the colorectal region, different results have been reported for improvement in&#xD;
      the adenoma detection rate of NBI compared with that of WLI. All procedures were performed up&#xD;
      to the cecum by using a high-definition colonoscope (GIF-HQ290I; Olympus Optical ) However,&#xD;
      whether NBI in high-definition colonoscope can increase the ADR after water exchange&#xD;
      insertion, remains to be elucidated. The aim of this study was therefore to determine whether&#xD;
      the use of NBI system as an adjunct to water exchange insertion would improve the ADR&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: Prospective single-blinded randomized controlled trial. Patients were randomly&#xD;
      assigned to control group or study group through a computer-based randomization list by a&#xD;
      technician. See also inclusion and exclusion criteria.&#xD;
&#xD;
      Colonoscopy was performed using high-definition colonoscope (GIF-HQ290I) after bowel&#xD;
      preparation. Experienced endoscopists (each with over 3000 colonoscopies performed) and&#xD;
      fellows (performed more than 600 colonoscopies) performed all procedures. During the&#xD;
      insertion phase, air pump was turned off to avoid inadvertent insufflations. Water exchange&#xD;
      with infusion pump was used to open the lumen and simultaneous suction of infused water to&#xD;
      allow passage of the scope in clear water. Suction of water can maximize cleanliness and&#xD;
      minimize distension. Air pockets at any location of the lumen were always aspirated. In a&#xD;
      collapsed colon, water turbulence formation at the tip of the scope facilitates residual&#xD;
      feces removal, salvage cleansing also be provided during insertion. Simethicone was used to&#xD;
      remove bubbles over the mucosa. Cecal intubation was defined as the passage of the scope tip&#xD;
      beyond the ileocecal valve with visualization of the cecal appendix. After cecal intubation,&#xD;
      as much residual water as possible was aspirated before beginning the withdrawal phase. The&#xD;
      same endoscopist uses the same assigned method to perform tandem or back-to-back colonoscopy&#xD;
      on all patients. After the first colonoscopic examination with the colonoscope removed from&#xD;
      the anus, using the same entry method for insertion and the same assigned method for the&#xD;
      second colon examination. In all arms, withdrawal lasted at least 9 minutes and was done&#xD;
      using air insufflation to obtain adequate distension. A stopwatch was used to time the&#xD;
      procedures, and time for polypectomy was not included.&#xD;
&#xD;
      Colon cleanliness was assessed using the Boston Bowel Preparation Scale (BBPS) and bubble&#xD;
      scores. Cardiopulmonary function was monitored throughout, and adverse outcomes were&#xD;
      recorded.&#xD;
&#xD;
      Study end points The primary outcome was to compare the ADR of the 290-NBI with the HD-WL.&#xD;
      Secondary outcomes included Right and left colon Adenoma Detection Rate. Right and left colon&#xD;
      &lt;10 mm Adenoma Detection Rate. Mean adenomas resected per procedure. Cecal intubation rate.&#xD;
      Cecal intubation time. Total withdrawal time. Amount of water used during the procedure.&#xD;
      Adenoma and polyp miss rate between the two group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 20, 2018</start_date>
  <completion_date type="Anticipated">October 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 20, 2022</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adenoma and polyp Detection Rate between the 290-NBI and the HD-WL group</measure>
    <time_frame>6 months</time_frame>
    <description>Overall ADR detection rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Right and left colon Adenoma Detection Rate</measure>
    <time_frame>6 months</time_frame>
    <description>ADR detection rate at different location</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Right and left colon &lt;10 mm Adenoma Detection Rate</measure>
    <time_frame>12 months</time_frame>
    <description>small polyp detection rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean adenomas resected per procedure</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of adenomas resected per subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total withdrawal time</measure>
    <time_frame>6 months</time_frame>
    <description>Total procedure time (including time required for polyp resection or biopsy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of water used during the procedure</measure>
    <time_frame>6 months</time_frame>
    <description>Amount of water used during insertion and withdrawal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adenoma and polyp miss rate between the two groups</measure>
    <time_frame>6 months</time_frame>
    <description>lesion miss rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">640</enrollment>
  <condition>Adenoma and Polyp Detection Rates</condition>
  <arm_group>
    <arm_group_label>WL withdrawal method</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Active Comparator: WL was used on withdrawal. During the insertion phase, air pump was turned off to avoid inadvertent insufflations. Water exchange with infusion pump was used to open the lumen and simultaneous suction of infused water to allow passage of the scope in clear water. Withdrawal phase done using air insufflation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NBI withdrawal method</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: NBI was used on withdrawal. During the insertion phase, air pump was turned off to avoid inadvertent insufflations. Water exchange with infusion pump was used to open the lumen and simultaneous suction of infused water to allow passage of the scope in clear water. Withdrawal phase done using air insufflation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>NBI withdrawal method</intervention_name>
    <description>The newly available second generation of NBI using the 290 system (290-NBI) provides an at least twofold brighter image compared with the previous version</description>
    <arm_group_label>NBI withdrawal method</arm_group_label>
    <arm_group_label>WL withdrawal method</arm_group_label>
    <other_name>Water exchange</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Any patient ≥40 and &lt;85 who underwent colonoscopy, does not meet exclusion criteria&#xD;
             mentioned below and provide written informed consent will be eligible for enrolment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • (1) history of inflammatory bowel disease;(2) familial adenomatous polyposis; (3)&#xD;
             hereditary non-polyposis colorectal cancer syndrome; (4) personal history of&#xD;
             colorectal cancer or had previous colonic resection; (5) haemodialysis; (6) an&#xD;
             American Society of Anaesthesiologists class III or higher; (7) antiplatelet or&#xD;
             anticoagulant therapy 5 days before the procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>tianyang zhang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>yuqi he, doctor</last_name>
    <phone>+801066721299</phone>
    <email>endohe@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Gastroenterology, PLA Army General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Dongcheng District</state>
        <zip>100700</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>yuqi he</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Cadoni S, Falt P, Rondonotti E, Radaelli F, Fojtik P, Gallittu P, Liggi M, Amato A, Paggi S, Smajstrla V, Urban O, Erriu M, Koo M, Leung FW. Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial. Endoscopy. 2017 May;49(5):456-467. doi: 10.1055/s-0043-101229. Epub 2017 Mar 10.</citation>
    <PMID>28282689</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>January 1, 2022</last_update_submitted>
  <last_update_submitted_qc>January 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>General Hospital of Beijing PLA Military Region</investigator_affiliation>
    <investigator_full_name>Yuqi He</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>After the research has been finished</ipd_description>
  </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/NCT03781648
org study id: PLA GH-water exchange-ADR
nct id: NCT03781648
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colorectal cancer remains the third most common cause of death from cancer worldwide. The
      adenoma detection rate is correlated with quality of colonoscopy and risk of postcolonoscopy
      CRC. Low quality of bowel preparation with fecal residue and brown liquid in the colon may
      lower the adenoma detection rate (ADR). Optimal bowel preparation and novel approaches for
      colonoscopy increases the effectiveness of colonoscopic examination to improve ADR are
      desirable. Water exchange, which significantly increased colon cleanliness both in the right
      colon and the entire colon, is characterized by insertion to the cecum in clear water in lieu
      of gas insufflations. Water exchange led to an increase in ADR, particularly for the
      improvement in the right colon, providing adequate bowel preparation.

      NBI is an innovative imaging technology which efficiency for the early detection of
      superficial cancers in the head and neck region and the esophagus had been reported
      previously. In the colorectal region, different results have been reported for improvement in
      the adenoma detection rate of NBI compared with that of WLI. All procedures were performed up
      to the cecum by using a high-definition colonoscope (GIF-HQ290I; Olympus Optical ) However,
      whether NBI in high-definition colonoscope can increase the ADR after water exchange
      insertion, remains to be elucidated. The aim of this study was therefore to determine whether
      the use of NBI system as an adjunct to water exchange insertion would improve the ADR
Design: Prospective single-blinded randomized controlled trial. Patients were randomly
      assigned to control group or study group through a computer-based randomization list by a
      technician. See also inclusion and exclusion criteria.

      Colonoscopy was performed using high-definition colonoscope (GIF-HQ290I) after bowel
      preparation. Experienced endoscopists (each with over 3000 colonoscopies performed) and
      fellows (performed more than 600 colonoscopies) performed all procedures. During the
      insertion phase, air pump was turned off to avoid inadvertent insufflations. Water exchange
      with infusion pump was used to open the lumen and simultaneous suction of infused water to
      allow passage of the scope in clear water. Suction of water can maximize cleanliness and
      minimize distension. Air pockets at any location of the lumen were always aspirated. In a
      collapsed colon, water turbulence formation at the tip of the scope facilitates residual
      feces removal, salvage cleansing also be provided during insertion. Simethicone was used to
      remove bubbles over the mucosa. Cecal intubation was defined as the passage of the scope tip
      beyond the ileocecal valve with visualization of the cecal appendix. After cecal intubation,
      as much residual water as possible was aspirated before beginning the withdrawal phase. The
      same endoscopist uses the same assigned method to perform tandem or back-to-back colonoscopy
      on all patients. After the first colonoscopic examination with the colonoscope removed from
      the anus, using the same entry method for insertion and the same assigned method for the
      second colon examination. In all arms, withdrawal lasted at least 9 minutes and was done
      using air insufflation to obtain adequate distension. A stopwatch was used to time the
      procedures, and time for polypectomy was not included.

      Colon cleanliness was assessed using the Boston Bowel Preparation Scale (BBPS) and bubble
      scores. Cardiopulmonary function was monitored throughout, and adverse outcomes were
      recorded.

      Study end points The primary outcome was to compare the ADR of the 290-NBI with the HD-WL.
      Secondary outcomes included Right and left colon Adenoma Detection Rate. Right and left colon
      <10 mm Adenoma Detection Rate. Mean adenomas resected per procedure. Cecal intubation rate.
      Cecal intubation time. Total withdrawal time. Amount of water used during the procedure.
      Adenoma and polyp miss rate between the two group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Care Provider)
measure: Adenoma and polyp Detection Rate between the 290-NBI and the HD-WL group
time frame: 6 months
description: Overall ADR detection rate
measure: Right and left colon Adenoma Detection Rate
time frame: 6 months
description: ADR detection rate at different location
measure: Right and left colon <10 mm Adenoma Detection Rate
time frame: 12 months
description: small polyp detection rate
measure: Mean adenomas resected per procedure
time frame: 6 months
description: Total number of adenomas resected per subject
measure: Total withdrawal time
time frame: 6 months
description: Total procedure time (including time required for polyp resection or biopsy)
measure: Amount of water used during the procedure
time frame: 6 months
description: Amount of water used during insertion and withdrawal
measure: adenoma and polyp miss rate between the two groups
time frame: 6 months
description: lesion miss rate
arm group label: WL withdrawal method
arm group type: Other
description: Active Comparator: WL was used on withdrawal. During the insertion phase, air pump was turned off to avoid inadvertent insufflations. Water exchange with infusion pump was used to open the lumen and simultaneous suction of infused water to allow passage of the scope in clear water. Withdrawal phase done using air insufflation.
arm group label: NBI withdrawal method
arm group type: Experimental
description: Experimental: NBI was used on withdrawal. During the insertion phase, air pump was turned off to avoid inadvertent insufflations. Water exchange with infusion pump was used to open the lumen and simultaneous suction of infused water to allow passage of the scope in clear water. Withdrawal phase done using air insufflation.
intervention type: Diagnostic Test
intervention name: NBI withdrawal method
description: The newly available second generation of NBI using the 290 system (290-NBI) provides an at least twofold brighter image compared with the previous version
arm group label: NBI withdrawal method
arm group label: WL withdrawal method
other name: Water exchange
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: tianyang zhang
role: Principal Investigator
affiliation: Medical department
last name: yuqi he, doctor
phone: +801066721299
email: endohe@163.com
facility: 
status: Recruiting
contact: 
country: China
citation: Cadoni S, Falt P, Rondonotti E, Radaelli F, Fojtik P, Gallittu P, Liggi M, Amato A, Paggi S, Smajstrla V, Urban O, Erriu M, Koo M, Leung FW. Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial. Endoscopy. 2017 May;49(5):456-467. doi: 10.1055/s-0043-101229. Epub 2017 Mar 10.
PMID: 28282689
responsible party type: Sponsor-Investigator
investigator affiliation: General Hospital of Beijing PLA Military Region
investigator full name: Yuqi He
investigator title: Principal Investigator, Clinical Professor
mesh term: Adenoma
sharing ipd: Undecided
ipd description: After the research has been finished