<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/NCT04418843</url>
  </required_header>
  <id_info>
    <org_study_id>RMEFRÍA.2019</org_study_id>
    <nct_id>NCT04418843</nct_id>
  </id_info>
  <brief_title>Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions</brief_title>
  <official_title>Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions.Randomized and Multicentric Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oscar Nogales</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Spanish Society of Digestive Endoscopy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</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>
      This study compares the effectiveness in complete resection (absence of recurrence at 6&#xD;
      months) the two different techniques for performing endoscopic mucosal resection (EMR) of&#xD;
      nonpedunculated homogeneous colorectal lesions &gt;20mm&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colonoscopy is the reference diagnostic test for the study of colon diseases. This procedure&#xD;
      also allows the realization of endoscopic therapeutics techniques; thus, endoscopic mucosal&#xD;
      resection (EMR) is an effective and safe therapy for the treatment of premalignant and early&#xD;
      malignant colorectal lesions of the colon and its use is universal.&#xD;
&#xD;
      Usually, colon lesions larger than 10 mm (or pedunculated of any size) require for resection&#xD;
      the use of electrocoagulation current (or hot snare polypectomy) and thus is reflected in the&#xD;
      most recent clinical practice guidelines (ESGE guidelines, for example). However, the risk of&#xD;
      side adverse effects from the use of electrocoagulation is not insignificant and includes&#xD;
      post-polypectomy bleeding, post-polypectomy syndrome, post-polypectomy fever and/or immediate&#xD;
      or delayed perforation. This risk of complications is higher depending on the characteristics&#xD;
      and size of colorectal lesions resected.&#xD;
&#xD;
      On the other hand, currently in small lesions not pedunculated (&lt; 10 mm), it is recommended&#xD;
      to use cold snare polypectomy according to ESGE clinical guidelines, as it has been seen in&#xD;
      previous studies that this reduces complication rates without varying the effectiveness in&#xD;
      resection.&#xD;
&#xD;
      However, in lesions &gt; 10 mm the previous experience with cold snare resection is less,&#xD;
      probably motivated by the possible drawbacks in terms of the possible difficulty of resection&#xD;
      of thick tissue with cold snare and a possible increased intra-procedure hemorrhagic risk&#xD;
      that can make it difficult to see the scar, with the possibility of leaving residual tissue.&#xD;
&#xD;
      However, in recent years the accumulated evidence gathered in various studies and grouped in&#xD;
      a recent systematic review suggests that endoscopic mucosal resection with cold snare&#xD;
      (Cold-EMR) may be safer than electrocoagulation resection for both 10-19mm lesions and for&#xD;
      lesions &gt;20 mm, associated with a lower rate of adverse effects with similar efficacy rates&#xD;
      in terms of complete resection and adenomatous recurrence rate. Still, evidence for the&#xD;
      treatment of nonpedunculated lesions &gt;20 mm is relatively limited and is not based on&#xD;
      randomized comparative studies with the standard EMR technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>
    <intervention_model_description>Prospective randomized study (1:1), multicenter, non-blind of consecutive non-pedunculated lesions of serrated and adenomatous histology, homogeneous, with a size greater than or equal to 20 mm (no upper limit in size). Performing cold-EMR vs standard EMR. A non-inferiority study of cold-EMR versus standard EMR.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete resection of the lesion</measure>
    <time_frame>3-6 months</time_frame>
    <description>Complete resection of the lesion is defined as the non-visualization by the endoscopist of a residual lesion in the mucosal defect and its edge at the end of the EMR and no visualization of recurrence in the post-EMR scar on the first surveillance colonoscopy and absence of recurrence data in scar biopsies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Security profile</measure>
    <time_frame>30 days</time_frame>
    <description>Security profile is defined as the observed percentage of complications (Intra-procedure bleeding, deferred bleeding, deferred bleeding in antiplatelet and/or anticoagulated patients,post-polypectomy fever, post-polypectomy syndrome, deep muscle damage and perforation) in each of the evaluated techniques.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late adenoma recurrence rate</measure>
    <time_frame>18 months</time_frame>
    <description>Late adenoma recurrence rate as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies) in surveillance colonoscopy at 18 months of the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of fragments needed to complete the resection</measure>
    <time_frame>1 day</time_frame>
    <description>Number of fragments needed to resect with polypectomy snare to complete the resection of the colorectal lesion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resection time</measure>
    <time_frame>1 day</time_frame>
    <description>Time needed to perform endoscopic mucosal resection measured from first snare positioning until complete resection is achieved based on endoscopic assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bloc resection rate</measure>
    <time_frame>1</time_frame>
    <description>Number of lesions that have undergone resection in a single fragment with each of these evaluated techniques.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>1 day</time_frame>
    <description>Number of lesions with complete macroscopic resection with a negative microscopic margin in the mucosectomy specimen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EMR technique conversion rate</measure>
    <time_frame>1 day</time_frame>
    <description>Number of lesions to be finally resected with the other arm of study technique not initially assigned</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for additional treatments to complete the resection.</measure>
    <time_frame>1 day</time_frame>
    <description>Number of lesions that cannot be completely resected with the assigned EMR technique, requiring different techniques to complete the resection, such as SOFT coagulation with snare tip, APC (argon plasma coagulation), hot avulsion with hot biopsy forceps, biopsy forceps, biopsy forceps +ablation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clips used</measure>
    <time_frame>1 day</time_frame>
    <description>Number of clip used for hemostatic purposes or for the prophylactic closure of the injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of artifact/interference in the histological interpretation</measure>
    <time_frame>1 day</time_frame>
    <description>Subjective impression of the artifact in the histological interpretation of the resected sample (null, moderate, severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depth of the resected submucosa</measure>
    <time_frame>1 day</time_frame>
    <description>Measure the depth of the resected submucosa layer (in microns) with each of the resection techniques used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of mucosal muscle present in the mucosal protrusions in the resection defect of cold-EMR.</measure>
    <time_frame>1 day</time_frame>
    <description>Assess the percentage of presence of mucosal muscle in biopsies performed on the protrusions present in the resection defect of cold-EMR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for surgery for technical failure</measure>
    <time_frame>6 months</time_frame>
    <description>Number of lesions that have to be finally resected by surgery due to technical impossibility for their endoscopic resection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness study.</measure>
    <time_frame>18 months</time_frame>
    <description>evaluate the cost-effectiveness of each of the endoscopic mucosal resection techniques</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-analysis by center participating in the study</measure>
    <time_frame>18 months</time_frame>
    <description>A subanalysis of the study results by center will be carried out to rule out significant differences between them</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">620</enrollment>
  <condition>Adenoma Colon</condition>
  <condition>Serrated Polyp</condition>
  <condition>Serrated Adenoma</condition>
  <condition>Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Standard Endoscopic Mucosal Resection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (&gt;20 mm)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cold Snare Endoscopic Mucosal Resection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cold Snare Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (&gt;20 mm)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Endoscopic Mucosal Resection</intervention_name>
    <description>Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery</description>
    <arm_group_label>Standard Endoscopic Mucosal Resection</arm_group_label>
    <other_name>Standard EMR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cold Snare Endoscopic Mucosal Resection</intervention_name>
    <description>Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery</description>
    <arm_group_label>Cold Snare Endoscopic Mucosal Resection</arm_group_label>
    <other_name>Cold EMR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of age &gt; 18 years undergoing a colonoscopy for any reason of request and who&#xD;
             do not meet exclusion criteria.&#xD;
&#xD;
          -  Nonpedunculated homogeneous colorectal lesions type LST ( Paris 0-IIa morphology) and&#xD;
             serrated lesions larger than 20 mm without endoscopic data of malignancy: NICE 1&#xD;
             pattern +/- NICE 2 component ( serrated lesions) or NICE2 pattern/JNET 2A (adenomas)&#xD;
             and therefore subsidiaries of RME. Randomization will be performed per patient, not&#xD;
             for colorectal lesions&#xD;
&#xD;
          -  Signature of informed consent of endoscopic exploration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  .No signature of informed consent prior to the study procedure.&#xD;
&#xD;
          -  Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to&#xD;
             procedure according to usual pre-procedure recommendations (BSG and ESGE guidelines)&#xD;
&#xD;
          -  Patients with severe thrombopenia/ coagulopathy (Platelets &lt; 50,000/INR &gt; 1.5) not&#xD;
             corrected prior to procedure (plasma or platelet transfusion)&#xD;
&#xD;
          -  Patients not candidates for endoscopic resection of colorectal lesions by&#xD;
             comorbidities.&#xD;
&#xD;
          -  Pregnant.&#xD;
&#xD;
          -  Patients with inflammatory bowel disease (IBD)&#xD;
&#xD;
          -  Urgent colonoscopy.&#xD;
&#xD;
          -  Poor preparation (BBPS &lt;2 in the colon segment where the lesion is located)&#xD;
&#xD;
          -  Laterally spreading tumors (LST) lesions with non-homogeneous morphology including:&#xD;
             sessile polyps (0-Is), pedunculated (0-Ip) and LST lesions with depressed or excavated&#xD;
             components (Paris 0-IIc or Paris 0-III), LST granular nodular mixed, LST-G with whole&#xD;
             nodular type. In case of doubt depressed component (Paris 0-IIc) or histological&#xD;
             borderline lesion (JNET2B), will be excluded from the study.&#xD;
&#xD;
          -  Histological prediction of deep invasive or non-subsidiary to endoscopic mucosal&#xD;
             resection lesion as a treatment of choice: NICE 3 pattern by inspection with NBI or&#xD;
             Kudo V pattern in traditional/electronic chromoendoscopy or Sano IIIA/IIIB pattern&#xD;
&#xD;
          -  Endoscopic resection of post-EMR scar level relapses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oscar Nogales</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital General Universitario Gregorio Marañon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Oscar Nogales</last_name>
    <phone>+34686948910</phone>
    <email>oscar.nogales@salud.madrid.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Óscar Nogales Rincón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oscar Nogales</last_name>
      <phone>+34 686 948 910</phone>
      <email>oscar.nogales@salud.madrid.org</email>
    </contact>
    <contact_backup>
      <last_name>Carlos Carbonell</last_name>
      <phone>+34 620 11 84 02</phone>
      <email>carbonell.blanco@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Thoguluva Chandrasekar V, Spadaccini M, Aziz M, Maselli R, Hassan S, Fuccio L, Duvvuri A, Frazzoni L, Desai M, Fugazza A, Jegadeesan R, Colombo M, Dasari CS, Hassan C, Sharma P, Repici A. Cold snare endoscopic resection of nonpedunculated colorectal polyps larger than 10 mm: a systematic review and pooled-analysis. Gastrointest Endosc. 2019 May;89(5):929-936.e3. doi: 10.1016/j.gie.2018.12.022. Epub 2019 Jan 9.</citation>
    <PMID>30639542</PMID>
  </reference>
  <reference>
    <citation>Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.</citation>
    <PMID>24125514</PMID>
  </reference>
  <reference>
    <citation>Takeuchi Y, Yamashina T, Matsuura N, Ito T, Fujii M, Nagai K, Matsui F, Akasaka T, Hanaoka N, Higashino K, Iishi H, Ishihara R, Thorlacius H, Uedo N. Feasibility of cold snare polypectomy in Japan: A pilot study. World J Gastrointest Endosc. 2015 Nov 25;7(17):1250-6. doi: 10.4253/wjge.v7.i17.1250.</citation>
    <PMID>26634041</PMID>
  </reference>
  <reference>
    <citation>Aslan F, Camci M, Alper E, Akpinar Z, Arabul M, Celik M, Unsal B. Cold snare polypectomy versus hot snare polypectomy in endoscopic treatment of small polyps. Turk J Gastroenterol. 2014 Jun;25(3):279-83. doi: 10.5152/tjg.2014.5085.</citation>
    <PMID>25141316</PMID>
  </reference>
  <reference>
    <citation>Tate DJ, Awadie H, Bahin FF, Desomer L, Lee R, Heitman SJ, Goodrick K, Bourke MJ. Wide-field piecemeal cold snare polypectomy of large sessile serrated polyps without a submucosal injection is safe. Endoscopy. 2018 Mar;50(3):248-252. doi: 10.1055/s-0043-121219. Epub 2017 Nov 23.</citation>
    <PMID>29169195</PMID>
  </reference>
  <reference>
    <citation>Hirose R, Yoshida N, Murakami T, Ogiso K, Inada Y, Dohi O, Okayama T, Kamada K, Uchiyama K, Handa O, Ishikawa T, Konishi H, Naito Y, Fujita Y, Kishimoto M, Yanagisawa A, Itoh Y. Histopathological analysis of cold snare polypectomy and its indication for colorectal polyps 10-14 mm in diameter. Dig Endosc. 2017 Jul;29(5):594-601. doi: 10.1111/den.12825. Epub 2017 May 17.</citation>
    <PMID>28160332</PMID>
  </reference>
  <reference>
    <citation>Rameshshanker R, Tsiamoulos Z, Latchford A, Moorghen M, Saunders BP. Resection of large sessile serrated polyps by cold piecemeal endoscopic mucosal resection: Serrated COld Piecemeal Endoscopic mucosal resection (SCOPE). Endoscopy. 2018 Jul;50(7):E165-E167. doi: 10.1055/a-0599-0346. Epub 2018 May 9. No abstract available.</citation>
    <PMID>29742770</PMID>
  </reference>
  <reference>
    <citation>Rex KD, Vemulapalli KC, Rex DK. Recurrence rates after EMR of large sessile serrated polyps. Gastrointest Endosc. 2015 Sep;82(3):538-41. doi: 10.1016/j.gie.2015.01.025. Epub 2015 Apr 4.</citation>
    <PMID>25851161</PMID>
  </reference>
  <reference>
    <citation>Qu J, Jian H, Li L, Zhang Y, Feng B, Li Z, Zuo X. Effectiveness and safety of cold versus hot snare polypectomy: A meta-analysis. J Gastroenterol Hepatol. 2019 Jan;34(1):49-58. doi: 10.1111/jgh.14464. Epub 2018 Sep 26.</citation>
    <PMID>30176072</PMID>
  </reference>
  <reference>
    <citation>Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, Dumonceau JM. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Endoscopy. 2016 Apr;48(4):c1. doi: 10.1055/s-0042-122686. Epub 2017 Jan 23. No abstract available.</citation>
    <PMID>28114689</PMID>
  </reference>
  <reference>
    <citation>Burgess NG, Bassan MS, McLeod D, Williams SJ, Byth K, Bourke MJ. Deep mural injury and perforation after colonic endoscopic mucosal resection: a new classification and analysis of risk factors. Gut. 2017 Oct;66(10):1779-1789. doi: 10.1136/gutjnl-2015-309848. Epub 2016 Jul 27.</citation>
    <PMID>27464708</PMID>
  </reference>
  <reference>
    <citation>Takayanagi D, Nemoto D, Isohata N, Endo S, Aizawa M, Utano K, Kumamoto K, Hojo H, Lefor AK, Togashi K. Histological Comparison of Cold versus Hot Snare Resections of the Colorectal Mucosa. Dis Colon Rectum. 2018 Aug;61(8):964-970. doi: 10.1097/DCR.0000000000001109.</citation>
    <PMID>29944582</PMID>
  </reference>
  <reference>
    <citation>Rodriguez Sanchez J, Sanchez Alonso M, Pellise Urquiza M. The &quot;bubble sign&quot;: a novel way to detect a perforation after cold snare polypectomy. Endoscopy. 2019 Aug;51(8):796-797. doi: 10.1055/a-0881-2856. Epub 2019 May 9. No abstract available.</citation>
    <PMID>31071753</PMID>
  </reference>
  <reference>
    <citation>Keklikkiran C, Ozdogan OC. Thermal ablation of mucosal defect margins reduces adenoma recurrence after colonic endoscopic mucosal resection. Turk J Gastroenterol. 2019 Jun;30(6):580-581. doi: 10.5152/tjg.2019.210519. No abstract available.</citation>
    <PMID>31144663</PMID>
  </reference>
  <reference>
    <citation>Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.</citation>
    <PMID>24986245</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Gregorio Marañon</investigator_affiliation>
    <investigator_full_name>Oscar Nogales</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>endoscopic mucosal resection</keyword>
  <keyword>cold snare endoscopic mucosal resection</keyword>
  <keyword>standard endoscopic mucosal resection</keyword>
  <keyword>large nonpedunculated homogeneous colorectal lesions</keyword>
  <keyword>adenoma colon</keyword>
  <keyword>serrated polyp</keyword>
  <keyword>serrated adenoma</keyword>
  <keyword>conventional endoscopic mucosal resection</keyword>
  <keyword>laterally spreading adenomas.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Colorectal Neoplasms</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/NCT04418843
org study id: RMEFRÍA.2019
nct id: NCT04418843
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study compares the effectiveness in complete resection (absence of recurrence at 6
      months) the two different techniques for performing endoscopic mucosal resection (EMR) of
      nonpedunculated homogeneous colorectal lesions >20mm
Colonoscopy is the reference diagnostic test for the study of colon diseases. This procedure
      also allows the realization of endoscopic therapeutics techniques; thus, endoscopic mucosal
      resection (EMR) is an effective and safe therapy for the treatment of premalignant and early
      malignant colorectal lesions of the colon and its use is universal.

      Usually, colon lesions larger than 10 mm (or pedunculated of any size) require for resection
      the use of electrocoagulation current (or hot snare polypectomy) and thus is reflected in the
      most recent clinical practice guidelines (ESGE guidelines, for example). However, the risk of
      side adverse effects from the use of electrocoagulation is not insignificant and includes
      post-polypectomy bleeding, post-polypectomy syndrome, post-polypectomy fever and/or immediate
      or delayed perforation. This risk of complications is higher depending on the characteristics
      and size of colorectal lesions resected.

      On the other hand, currently in small lesions not pedunculated (< 10 mm), it is recommended
      to use cold snare polypectomy according to ESGE clinical guidelines, as it has been seen in
      previous studies that this reduces complication rates without varying the effectiveness in
      resection.

      However, in lesions > 10 mm the previous experience with cold snare resection is less,
      probably motivated by the possible drawbacks in terms of the possible difficulty of resection
      of thick tissue with cold snare and a possible increased intra-procedure hemorrhagic risk
      that can make it difficult to see the scar, with the possibility of leaving residual tissue.

      However, in recent years the accumulated evidence gathered in various studies and grouped in
      a recent systematic review suggests that endoscopic mucosal resection with cold snare
      (Cold-EMR) may be safer than electrocoagulation resection for both 10-19mm lesions and for
      lesions >20 mm, associated with a lower rate of adverse effects with similar efficacy rates
      in terms of complete resection and adenomatous recurrence rate. Still, evidence for the
      treatment of nonpedunculated lesions >20 mm is relatively limited and is not based on
      randomized comparative studies with the standard EMR technique.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective randomized study (1:1), multicenter, non-blind of consecutive non-pedunculated lesions of serrated and adenomatous histology, homogeneous, with a size greater than or equal to 20 mm (no upper limit in size). Performing cold-EMR vs standard EMR. A non-inferiority study of cold-EMR versus standard EMR.
primary purpose: Treatment
masking: None (Open Label)
measure: Complete resection of the lesion
time frame: 3-6 months
description: Complete resection of the lesion is defined as the non-visualization by the endoscopist of a residual lesion in the mucosal defect and its edge at the end of the EMR and no visualization of recurrence in the post-EMR scar on the first surveillance colonoscopy and absence of recurrence data in scar biopsies
measure: Security profile
time frame: 30 days
description: Security profile is defined as the observed percentage of complications (Intra-procedure bleeding, deferred bleeding, deferred bleeding in antiplatelet and/or anticoagulated patients,post-polypectomy fever, post-polypectomy syndrome, deep muscle damage and perforation) in each of the evaluated techniques.
measure: Late adenoma recurrence rate
time frame: 18 months
description: Late adenoma recurrence rate as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies) in surveillance colonoscopy at 18 months of the procedure
measure: Number of fragments needed to complete the resection
time frame: 1 day
description: Number of fragments needed to resect with polypectomy snare to complete the resection of the colorectal lesion.
measure: Resection time
time frame: 1 day
description: Time needed to perform endoscopic mucosal resection measured from first snare positioning until complete resection is achieved based on endoscopic assessment.
measure: Bloc resection rate
time frame: 1
description: Number of lesions that have undergone resection in a single fragment with each of these evaluated techniques.
measure: R0 resection rate
time frame: 1 day
description: Number of lesions with complete macroscopic resection with a negative microscopic margin in the mucosectomy specimen
measure: EMR technique conversion rate
time frame: 1 day
description: Number of lesions to be finally resected with the other arm of study technique not initially assigned
measure: Need for additional treatments to complete the resection.
time frame: 1 day
description: Number of lesions that cannot be completely resected with the assigned EMR technique, requiring different techniques to complete the resection, such as SOFT coagulation with snare tip, APC (argon plasma coagulation), hot avulsion with hot biopsy forceps, biopsy forceps, biopsy forceps +ablation
measure: Number of clips used
time frame: 1 day
description: Number of clip used for hemostatic purposes or for the prophylactic closure of the injury
measure: Degree of artifact/interference in the histological interpretation
time frame: 1 day
description: Subjective impression of the artifact in the histological interpretation of the resected sample (null, moderate, severe)
measure: Depth of the resected submucosa
time frame: 1 day
description: Measure the depth of the resected submucosa layer (in microns) with each of the resection techniques used
measure: Percentage of mucosal muscle present in the mucosal protrusions in the resection defect of cold-EMR.
time frame: 1 day
description: Assess the percentage of presence of mucosal muscle in biopsies performed on the protrusions present in the resection defect of cold-EMR
measure: Need for surgery for technical failure
time frame: 6 months
description: Number of lesions that have to be finally resected by surgery due to technical impossibility for their endoscopic resection.
measure: Cost-effectiveness study.
time frame: 18 months
description: evaluate the cost-effectiveness of each of the endoscopic mucosal resection techniques
measure: Sub-analysis by center participating in the study
time frame: 18 months
description: A subanalysis of the study results by center will be carried out to rule out significant differences between them
arm group label: Standard Endoscopic Mucosal Resection
arm group type: Experimental
description: Standard Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (>20 mm)
arm group label: Cold Snare Endoscopic Mucosal Resection
arm group type: Experimental
description: Cold Snare Endoscopic Mucosal Resection, if necessary, multi-piece to resect large nonpedunculated homogeneous colorectal lesions (>20 mm)
intervention type: Procedure
intervention name: Standard Endoscopic Mucosal Resection
description: Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery
arm group label: Standard Endoscopic Mucosal Resection
other name: Standard EMR
intervention type: Procedure
intervention name: Cold Snare Endoscopic Mucosal Resection
description: Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery
arm group label: Cold Snare Endoscopic Mucosal Resection
other name: Cold EMR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Oscar Nogales
role: Principal Investigator
affiliation: Hospital General Universitario Gregorio Marañon
last name: Oscar Nogales
phone: +34686948910
email: oscar.nogales@salud.madrid.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
citation: Thoguluva Chandrasekar V, Spadaccini M, Aziz M, Maselli R, Hassan S, Fuccio L, Duvvuri A, Frazzoni L, Desai M, Fugazza A, Jegadeesan R, Colombo M, Dasari CS, Hassan C, Sharma P, Repici A. Cold snare endoscopic resection of nonpedunculated colorectal polyps larger than 10 mm: a systematic review and pooled-analysis. Gastrointest Endosc. 2019 May;89(5):929-936.e3. doi: 10.1016/j.gie.2018.12.022. Epub 2019 Jan 9.
PMID: 30639542
citation: Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.
PMID: 24125514
citation: Takeuchi Y, Yamashina T, Matsuura N, Ito T, Fujii M, Nagai K, Matsui F, Akasaka T, Hanaoka N, Higashino K, Iishi H, Ishihara R, Thorlacius H, Uedo N. Feasibility of cold snare polypectomy in Japan: A pilot study. World J Gastrointest Endosc. 2015 Nov 25;7(17):1250-6. doi: 10.4253/wjge.v7.i17.1250.
PMID: 26634041
citation: Aslan F, Camci M, Alper E, Akpinar Z, Arabul M, Celik M, Unsal B. Cold snare polypectomy versus hot snare polypectomy in endoscopic treatment of small polyps. Turk J Gastroenterol. 2014 Jun;25(3):279-83. doi: 10.5152/tjg.2014.5085.
PMID: 25141316
citation: Tate DJ, Awadie H, Bahin FF, Desomer L, Lee R, Heitman SJ, Goodrick K, Bourke MJ. Wide-field piecemeal cold snare polypectomy of large sessile serrated polyps without a submucosal injection is safe. Endoscopy. 2018 Mar;50(3):248-252. doi: 10.1055/s-0043-121219. Epub 2017 Nov 23.
PMID: 29169195
citation: Hirose R, Yoshida N, Murakami T, Ogiso K, Inada Y, Dohi O, Okayama T, Kamada K, Uchiyama K, Handa O, Ishikawa T, Konishi H, Naito Y, Fujita Y, Kishimoto M, Yanagisawa A, Itoh Y. Histopathological analysis of cold snare polypectomy and its indication for colorectal polyps 10-14 mm in diameter. Dig Endosc. 2017 Jul;29(5):594-601. doi: 10.1111/den.12825. Epub 2017 May 17.
PMID: 28160332
citation: Rameshshanker R, Tsiamoulos Z, Latchford A, Moorghen M, Saunders BP. Resection of large sessile serrated polyps by cold piecemeal endoscopic mucosal resection: Serrated COld Piecemeal Endoscopic mucosal resection (SCOPE). Endoscopy. 2018 Jul;50(7):E165-E167. doi: 10.1055/a-0599-0346. Epub 2018 May 9. No abstract available.
PMID: 29742770
citation: Rex KD, Vemulapalli KC, Rex DK. Recurrence rates after EMR of large sessile serrated polyps. Gastrointest Endosc. 2015 Sep;82(3):538-41. doi: 10.1016/j.gie.2015.01.025. Epub 2015 Apr 4.
PMID: 25851161
citation: Qu J, Jian H, Li L, Zhang Y, Feng B, Li Z, Zuo X. Effectiveness and safety of cold versus hot snare polypectomy: A meta-analysis. J Gastroenterol Hepatol. 2019 Jan;34(1):49-58. doi: 10.1111/jgh.14464. Epub 2018 Sep 26.
PMID: 30176072
citation: Veitch AM, Vanbiervliet G, Gershlick AH, Boustiere C, Baglin TP, Smith LA, Radaelli F, Knight E, Gralnek IM, Hassan C, Dumonceau JM. Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Endoscopy. 2016 Apr;48(4):c1. doi: 10.1055/s-0042-122686. Epub 2017 Jan 23. No abstract available.
PMID: 28114689
citation: Burgess NG, Bassan MS, McLeod D, Williams SJ, Byth K, Bourke MJ. Deep mural injury and perforation after colonic endoscopic mucosal resection: a new classification and analysis of risk factors. Gut. 2017 Oct;66(10):1779-1789. doi: 10.1136/gutjnl-2015-309848. Epub 2016 Jul 27.
PMID: 27464708
citation: Takayanagi D, Nemoto D, Isohata N, Endo S, Aizawa M, Utano K, Kumamoto K, Hojo H, Lefor AK, Togashi K. Histological Comparison of Cold versus Hot Snare Resections of the Colorectal Mucosa. Dis Colon Rectum. 2018 Aug;61(8):964-970. doi: 10.1097/DCR.0000000000001109.
PMID: 29944582
citation: Rodriguez Sanchez J, Sanchez Alonso M, Pellise Urquiza M. The "bubble sign": a novel way to detect a perforation after cold snare polypectomy. Endoscopy. 2019 Aug;51(8):796-797. doi: 10.1055/a-0881-2856. Epub 2019 May 9. No abstract available.
PMID: 31071753
citation: Keklikkiran C, Ozdogan OC. Thermal ablation of mucosal defect margins reduces adenoma recurrence after colonic endoscopic mucosal resection. Turk J Gastroenterol. 2019 Jun;30(6):580-581. doi: 10.5152/tjg.2019.210519. No abstract available.
PMID: 31144663
citation: Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.
PMID: 24986245
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: Oscar Nogales
investigator title: Principal Investigator
mesh term: Adenoma
mesh term: Colorectal Neoplasms
sharing ipd: No