<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/NCT01712048</url>
  </required_header>
  <id_info>
    <org_study_id>2012.070-2</org_study_id>
    <nct_id>NCT01712048</nct_id>
  </id_info>
  <brief_title>Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps</brief_title>
  <acronym>IvU</acronym>
  <official_title>Submucosal Injection Assisted Endoscopic Resection vs. Underwater EMR for Large Sessile Colorectal Polyps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>California Pacific Medical Center Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>California Pacific Medical Center Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the efficacy and safety of two standard methods of&#xD;
      polypectomy (polyp removal), submucosal injection-assisted endoscopic mucosal resection (EMR)&#xD;
      and full water emersion (without submucosal injection) EMR, for large colorectal polyps.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The endoscopic resection of benign colon polyps (polypectomy) plays a vital role in the&#xD;
      prevention of colo-rectal cancer. While, small pedunculated polyps are removed with ease,&#xD;
      large flat lesions pose a greater challenge. As a result, special techniques have been&#xD;
      developed to assist in the removal of these difficult polyps.&#xD;
&#xD;
      During conventional colonoscopy with polypectomy, the colon lumen is insufflated with air,&#xD;
      which flattens polyps and thins the wall of the colon. These two factors increase the risk of&#xD;
      procedural complications such as bleeding and perforation. In order to counter these&#xD;
      drawbacks a technique, which involves the injection of saline into the submucosal area&#xD;
      beneath the polyp, is commonly used for the resection of large flat polyps. Theoretically,&#xD;
      the injection creates a &quot;safety cushion&quot; that reduces the risks of accidental ensnarement of&#xD;
      the muscularis propria, which can lead to iatrogenic perforation and thermal injury to the&#xD;
      deeper tissue layers. However, the submucosal injection technique is cumbersome in patients&#xD;
      with particularly large polyps as multiple injections are often necessary, which can blur the&#xD;
      line between normal and abnormal tissue.&#xD;
&#xD;
      Water emersion colonoscopy is a well-established alternative to conventional &quot;air&quot;&#xD;
      colonoscopy and is in fact preferred by many endoscopists. Studies have shown that using&#xD;
      water instead of air decreases the discomfort of colonoscopy, measured by the amount of&#xD;
      sedative and pain medication used, time to complete the colonoscopy, and recovery time, and&#xD;
      increases cecal intubation rates. Interventional Endoscopy Services (IES) at CPMC has taken&#xD;
      the concepts of water emersion colonoscopy one step further in order to developed a novel&#xD;
      method of &quot;underwater&quot; EMR. This technique was inspired by the observation that the&#xD;
      muscularis propria of the colon retains its native thickness (1-2 mm) and circular&#xD;
      configuration during underwater EUS examination. Furthermore, water immersion &quot;floats&quot;&#xD;
      mucosal lesions away from the deeper wall layers, eliminating the need for a &quot;safety cushion&quot;&#xD;
      created by submucosal injection. One drawback to the underwater technique is that in the case&#xD;
      of poor preps, residual feces in the colon is suspended in the water, interfering with&#xD;
      visualization. Additionally, the use of water often causes soiling of the gurney as a result&#xD;
      of water seepage from the rectum during the procedure, which requires additional sanitary&#xD;
      attention during the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adenoma recurrence rate</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse event rate</measure>
    <time_frame>48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Colonic Polyps</condition>
  <condition>Rectal Polyps</condition>
  <arm_group>
    <arm_group_label>Submucosal Injection EMR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For patients who are randomized to the &quot;submucosal injection&quot; arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a &quot;safety cushion&quot; for resection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Underwater EMR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For patients who are randomized to the &quot;underwater&quot; arm polypectomy with water will be performed under full water emersion without the use of submucosal injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Submucosal Injection EMR</intervention_name>
    <description>Selective saline injection is applied to the layer of tissue underneath the polyp in order to create a &quot;safety cushion&quot; for resection. EMR is then performed with a standard snare.</description>
    <arm_group_label>Submucosal Injection EMR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Underwater EMR</intervention_name>
    <description>Polypectomy is performed under full water emersion without the use of submucosal injection.</description>
    <arm_group_label>Underwater EMR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age &gt;18 years that are scheduled for endoscopic resection of large&#xD;
             colo-rectal lesions who consent to this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to provide informed consent.&#xD;
&#xD;
          -  Patients with lesions showing adenoma invasion into the muscularis propria on EUS.&#xD;
&#xD;
          -  Patients without at least one colo-rectal lesions ≥ 20mm.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth Binmoeller, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>California Pacific Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christopher Hamerski, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>California Pacific Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California Pacific Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>ROSENBERG N. Submucosal saline wheal as safety factor in fulguration or rectal and sigmoidal polypi. AMA Arch Surg. 1955 Jan;70(1):120-2. doi: 10.1001/archsurg.1955.01270070122021. No abstract available.</citation>
    <PMID>13217613</PMID>
  </reference>
  <reference>
    <citation>Norton ID, Wang L, Levine SA, Burgart LJ, Hofmeister EK, Rumalla A, Gostout CJ, Petersen BT. Efficacy of colonic submucosal saline solution injection for the reduction of iatrogenic thermal injury. Gastrointest Endosc. 2002 Jul;56(1):95-9. doi: 10.1067/mge.2002.125362.</citation>
    <PMID>12085042</PMID>
  </reference>
  <reference>
    <citation>Nelson DB. Techniques for difficult polypectomy. MedGenMed. 2004 Oct 25;6(4):12. No abstract available.</citation>
    <PMID>15775839</PMID>
  </reference>
  <reference>
    <citation>Zarchy T. Risk of submucosal saline injection for colonic polypectomy. Gastrointest Endosc. 1997 Jul;46(1):89-90. doi: 10.1016/s0016-5107(97)70222-0. No abstract available.</citation>
    <PMID>9260717</PMID>
  </reference>
  <reference>
    <citation>Kudo S, Kashida H, Nakajima T, Tamura S, Nakajo K. Endoscopic diagnosis and treatment of early colorectal cancer. World J Surg. 1997 Sep;21(7):694-701. doi: 10.1007/s002689900293.</citation>
    <PMID>9276699</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>California Pacific Medical Center Research Institute</investigator_affiliation>
    <investigator_full_name>Kenneth Binmoeller</investigator_full_name>
    <investigator_title>Interventional Endoscopy Program Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyps</mesh_term>
    <mesh_term>Colonic Polyps</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/NCT01712048
org study id: 2012.070-2
nct id: NCT01712048
lead sponsor: 
has dmc: No
The aim of this study is to compare the efficacy and safety of two standard methods of
      polypectomy (polyp removal), submucosal injection-assisted endoscopic mucosal resection (EMR)
      and full water emersion (without submucosal injection) EMR, for large colorectal polyps.
The endoscopic resection of benign colon polyps (polypectomy) plays a vital role in the
      prevention of colo-rectal cancer. While, small pedunculated polyps are removed with ease,
      large flat lesions pose a greater challenge. As a result, special techniques have been
      developed to assist in the removal of these difficult polyps.

      During conventional colonoscopy with polypectomy, the colon lumen is insufflated with air,
      which flattens polyps and thins the wall of the colon. These two factors increase the risk of
      procedural complications such as bleeding and perforation. In order to counter these
      drawbacks a technique, which involves the injection of saline into the submucosal area
      beneath the polyp, is commonly used for the resection of large flat polyps. Theoretically,
      the injection creates a "safety cushion" that reduces the risks of accidental ensnarement of
      the muscularis propria, which can lead to iatrogenic perforation and thermal injury to the
      deeper tissue layers. However, the submucosal injection technique is cumbersome in patients
      with particularly large polyps as multiple injections are often necessary, which can blur the
      line between normal and abnormal tissue.

      Water emersion colonoscopy is a well-established alternative to conventional "air"
      colonoscopy and is in fact preferred by many endoscopists. Studies have shown that using
      water instead of air decreases the discomfort of colonoscopy, measured by the amount of
      sedative and pain medication used, time to complete the colonoscopy, and recovery time, and
      increases cecal intubation rates. Interventional Endoscopy Services (IES) at CPMC has taken
      the concepts of water emersion colonoscopy one step further in order to developed a novel
      method of "underwater" EMR. This technique was inspired by the observation that the
      muscularis propria of the colon retains its native thickness (1-2 mm) and circular
      configuration during underwater EUS examination. Furthermore, water immersion "floats"
      mucosal lesions away from the deeper wall layers, eliminating the need for a "safety cushion"
      created by submucosal injection. One drawback to the underwater technique is that in the case
      of poor preps, residual feces in the colon is suspended in the water, interfering with
      visualization. Additionally, the use of water often causes soiling of the gurney as a result
      of water seepage from the rectum during the procedure, which requires additional sanitary
      attention during the procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adenoma recurrence rate
time frame: 6 months
measure: Adverse event rate
time frame: 48 hours
measure: Procedure time
time frame: 24 hours
arm group label: Submucosal Injection EMR
arm group type: Active Comparator
description: For patients who are randomized to the "submucosal injection" arm polypectomy will be performed with selective saline injection to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection.
arm group label: Underwater EMR
arm group type: Active Comparator
description: For patients who are randomized to the "underwater" arm polypectomy with water will be performed under full water emersion without the use of submucosal injection.
intervention type: Procedure
intervention name: Submucosal Injection EMR
description: Selective saline injection is applied to the layer of tissue underneath the polyp in order to create a "safety cushion" for resection. EMR is then performed with a standard snare.
arm group label: Submucosal Injection EMR
intervention type: Procedure
intervention name: Underwater EMR
description: Polypectomy is performed under full water emersion without the use of submucosal injection.
arm group label: Underwater EMR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kenneth Binmoeller, M.D.
role: Principal Investigator
affiliation: California Pacific Medical Center
last name: Christopher Hamerski, M.D.
role: Study Director
affiliation: California Pacific Medical Center
facility: 
country: United States
citation: ROSENBERG N. Submucosal saline wheal as safety factor in fulguration or rectal and sigmoidal polypi. AMA Arch Surg. 1955 Jan;70(1):120-2. doi: 10.1001/archsurg.1955.01270070122021. No abstract available.
PMID: 13217613
citation: Norton ID, Wang L, Levine SA, Burgart LJ, Hofmeister EK, Rumalla A, Gostout CJ, Petersen BT. Efficacy of colonic submucosal saline solution injection for the reduction of iatrogenic thermal injury. Gastrointest Endosc. 2002 Jul;56(1):95-9. doi: 10.1067/mge.2002.125362.
PMID: 12085042
citation: Nelson DB. Techniques for difficult polypectomy. MedGenMed. 2004 Oct 25;6(4):12. No abstract available.
PMID: 15775839
citation: Zarchy T. Risk of submucosal saline injection for colonic polypectomy. Gastrointest Endosc. 1997 Jul;46(1):89-90. doi: 10.1016/s0016-5107(97)70222-0. No abstract available.
PMID: 9260717
citation: Kudo S, Kashida H, Nakajima T, Tamura S, Nakajo K. Endoscopic diagnosis and treatment of early colorectal cancer. World J Surg. 1997 Sep;21(7):694-701. doi: 10.1007/s002689900293.
PMID: 9276699
responsible party type: Principal Investigator
investigator affiliation: California Pacific Medical Center Research Institute
investigator full name: Kenneth Binmoeller
investigator title: Interventional Endoscopy Program Director
mesh term: Polyps
mesh term: Colonic Polyps