<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/NCT03803891</url>
  </required_header>
  <id_info>
    <org_study_id>HU-EMPRET</org_study_id>
    <nct_id>NCT03803891</nct_id>
  </id_info>
  <brief_title>Endoscopic Full-Thickness Resection In Colon</brief_title>
  <acronym>EFTRICOM</acronym>
  <official_title>Multicenter Prospective Study of Endoscopic Full-thickness Resection (EFTR) in Colon Using Over-the-scope-clip (OTSC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut Germans Trias i Pujol</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Spanish Society of Digestive Endoscopy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital de Sant Joan Despí Moisès Broggi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Complejo Hospitalario de Navarra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clínico Universitario de Santiago de Compostela</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Provincial de Castellon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Althaia Xarxa Assistencial Universitària de Manresa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Mutua de Terrassa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital General Universitario Gregorio Marañon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital San Carlos, Madrid</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario 12 de Octubre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital General de Ciudad Real</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital General Universitario Elche</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario Central de Asturias</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Quironsalud</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario La Paz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro Medico Teknon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Germans Trias i Pujol Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundació Institut Germans Trias i Pujol</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>
      Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC)&#xD;
      as a closure mechanism is a recent technique that allows the endoscopic resection of colonic&#xD;
      lesions that are poor candidates for conventional endoscopic resection techniques. The aim is&#xD;
      to study the safety and efficacy of EFTR in colon.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Early detection and endoscopic resection of early neoplastic lesions in colon can prevent the&#xD;
      development of colon cancer.&#xD;
&#xD;
      The classic endoscopic mucosal resection technique and the submucosal dissection technique&#xD;
      require the creation of a submucosal &quot;cushion&quot; by injecting crystalloid substances or&#xD;
      colloids. However, these advanced techniques have technical limitations when facing a lesion&#xD;
      that presents poor lifting or non-lifting at all as it might be observed in scarring or&#xD;
      fibrotic lesions&#xD;
&#xD;
      Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC)&#xD;
      is a recent technique that does not require the injection of a submucosal solution and allows&#xD;
      a resection of colonic lesions of up to approximately 30 mm, en bloc, allowing a correct&#xD;
      histological study of the sample, to confirm its complete resection with adequate deep&#xD;
      margins, evaluation of the level of invasion and lymphovascular involvement.&#xD;
&#xD;
      EFTR with OTSC allows a colonic wall full-thickness resection, by the deployment of an&#xD;
      over-the-scope clip before the resection of the lesion to prevent perforation. The steps of&#xD;
      the technique are: face the lesion and marking the borders, insertion of the scope with the&#xD;
      kit (consisting of a cap with an integrated snare and OTSC), grasping and pulling the lesion&#xD;
      into the cap, deploy the over-the-scope-clip (OTSC) and closing the integrated snare and&#xD;
      resect.&#xD;
&#xD;
      This is a multicenter observational study on the efficacy and safety of EFTR with OTSC in&#xD;
      colon.&#xD;
&#xD;
      The clinical, endoscopic and histological data are collected prospectively in all cases of&#xD;
      EFTR performed in the participant centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Anticipated">July 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Technical Success</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Percentage of complete en-bloc resection of the lesion without macroscopic residual tissue after completing the endoscopic full-thickness resection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse events</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of procedure-associated major adverse events: bleeding and/or perforation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histologically confirmed full-thickness resection</measure>
    <time_frame>30 days</time_frame>
    <description>Histologically confirmed full-thickness resection</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">65</enrollment>
  <condition>Colon Neoplasm, Malignant</condition>
  <condition>Colo-rectal Cancer</condition>
  <condition>Colonic Cancer</condition>
  <condition>Colonic Adenoma</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Colorectal Neoplasms</condition>
  <condition>Colorectal Adenocarcinoma</condition>
  <condition>Colon Polyp</condition>
  <condition>Colon Lesion</condition>
  <condition>Colon Neoplasm</condition>
  <arm_group>
    <arm_group_label>Endoscopic full-thickness resection</arm_group_label>
    <description>Patients with neoplastic lesions less than 30mm unresectable en bloc by other less invasive endoscopic techniques, including lesions suggestive of T1 colorectal cancer, subepithelial tumors, lesions with diverticular involvement, lesions with no-lifting sign (recurrent, incomplete prior resection or untreated lesions).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic full-thickness resection</intervention_name>
    <description>Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions</description>
    <arm_group_label>Endoscopic full-thickness resection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who undergo a endoscopic full-thickness resection for colonic lesions who meet&#xD;
        the inclusion criteria will be included consecutively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (≥18 years) of both sexes.&#xD;
&#xD;
          -  Colonic lesions less than 30mm unresectable en-bloc by other less invasive endoscopic&#xD;
             techniques, including lesions suggestive of T1, subepithelial tumors, lesions with&#xD;
             diverticular involvement, lesions with no-lifting signs (recurrent, incomplete prior&#xD;
             resection or untreated).&#xD;
&#xD;
          -  Patients who give their written informed consent for the procedure and for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to grant informed consent.&#xD;
&#xD;
          -  Neoplastic lesions of the colon with evidence of advanced stage (for example, lymph&#xD;
             node involvement) or more than 3 cm in greatest diameter.&#xD;
&#xD;
          -  Any medical, psychological, geographical, or social problem that is significant and&#xD;
             uncontrolled that may interfere with the patient's participation in the study or that&#xD;
             does not allow adequate follow-up and adherence to the protocol and evaluation of the&#xD;
             results of the study.&#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>Hugo I. Uchima Koecklin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical researcher</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hugo I. Uchima Koecklin, MD</last_name>
    <phone>+34 934978866</phone>
    <email>hugoikuo@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Magin Farré Albadalejo</last_name>
    <email>mfarre.germanstrias@gencat.cat</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>jsolavera@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Javier Sola Vera</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fundació Althaia, Xarxa Assistencial Universitària de Manresa</name>
      <address>
        <city>Manresa</city>
        <state>Barcelona</state>
        <zip>08243</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>ignasipuig@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Ignasi Puig del Castillo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital de Sant Joan Despí Moisès Broggi</name>
      <address>
        <city>Sant Joan Despí</city>
        <state>Barcelona</state>
        <zip>08970</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>alexfsimon@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Alejandro Fernández</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital de Sant Joan Despí Moisès Broggi</name>
      <address>
        <city>Sant Joan Despí</city>
        <state>Barcelona</state>
        <zip>08970</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>alfredomatabil@yahoo.es</email>
    </contact>
    <investigator>
      <last_name>Alfredo Mata Bilbao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital de Sant Joan Despí Moisès Broggi</name>
      <address>
        <city>Sant Joan Despí</city>
        <state>Barcelona</state>
        <zip>08970</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>David.BarqueroDeclara@sanitatintegral.org</email>
    </contact>
    <investigator>
      <last_name>David Barquero</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Mútua de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona</state>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>jcespinos@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jorge Carlos Espinós</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Consorcio Hospitalario Provincial de Castellón</name>
      <address>
        <city>Castelló de la Plana</city>
        <state>Castellón</state>
        <zip>12002</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>sabado@uji.es</email>
    </contact>
    <investigator>
      <last_name>Fernando Sábado</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago De Compostela</city>
        <state>La Coruña</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>franmartingastro@yahoo.es</email>
    </contact>
    <investigator>
      <last_name>Francisco Martín</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>edualbeniz@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Eduardo Albéniz</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>MPELLISE@clinic.cat</email>
    </contact>
    <investigator>
      <last_name>Maria Pellisé</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Ciudad Real</name>
      <address>
        <city>Ciudad Real</city>
        <zip>13005</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>joakinrodriguez@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Joaquín Rodríguez Sánchez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>jgarcialledo@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Javier García Lledó</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>jestebanl@yahoo.es</email>
    </contact>
    <investigator>
      <last_name>José Miguel Esteban</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>josecarlos.marin@salud.madrid.org</email>
    </contact>
    <investigator>
      <last_name>José Carlos Marín Gabriel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>pedro.demaria@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Pedro De María Pallarés</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Quirónsalud Málaga</name>
      <address>
        <city>Málaga</city>
        <zip>29004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>pjroson@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Pedro J. Rosón</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>miguelfrailelopez@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Miguel Fraile López</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Schmidt A, Meier B, Caca K. Endoscopic full-thickness resection: Current status. World J Gastroenterol. 2015 Aug 21;21(31):9273-85. doi: 10.3748/wjg.v21.i31.9273.</citation>
    <PMID>26309354</PMID>
  </reference>
  <reference>
    <citation>Uchima H, Barquero D, Fernandez A, Mata A, Huertas C, Figa M, Hombrados M, Espinos JC. Su1638 Early Discharge After Endoscopic Full-Thickness Resection in the Colorectum. Gastrointest Endosc. 2017;85:5, AB375</citation>
  </reference>
  <reference>
    <citation>Schmidt A, Beyna T, Schumacher B, Meining A, Richter-Schrag HJ, Messmann H, Neuhaus H, Albers D, Birk M, Thimme R, Probst A, Faehndrich M, Frieling T, Goetz M, Riecken B, Caca K. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut. 2018 Jul;67(7):1280-1289. doi: 10.1136/gutjnl-2016-313677. Epub 2017 Aug 10.</citation>
    <PMID>28798042</PMID>
  </reference>
  <reference>
    <citation>Backes Y, Kappelle WFW, Berk L, Koch AD, Groen JN, de Vos Tot Nederveen Cappel WH, Schwartz MP, Kerkhof M, Siersema PD, Schroder R, Tan TG, Lacle MM, Vleggaar FP, Moons LMG; T1 CRC Working Group. Colorectal endoscopic full-thickness resection using a novel, flat-base over-the-scope clip: a prospective study. Endoscopy. 2017 Nov;49(11):1092-1097. doi: 10.1055/s-0043-114730. Epub 2017 Jul 28.</citation>
    <PMID>28753696</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundació Institut Germans Trias i Pujol</investigator_affiliation>
    <investigator_full_name>HugoUchima</investigator_full_name>
    <investigator_title>Medical Specialist (gastroenterologist, MD)</investigator_title>
  </responsible_party>
  <keyword>Endoscopic resection</keyword>
  <keyword>Colonoscopy</keyword>
  <keyword>Full-thickness resection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Colonic 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/NCT03803891
org study id: HU-EMPRET
nct id: NCT03803891
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC)
      as a closure mechanism is a recent technique that allows the endoscopic resection of colonic
      lesions that are poor candidates for conventional endoscopic resection techniques. The aim is
      to study the safety and efficacy of EFTR in colon.
Early detection and endoscopic resection of early neoplastic lesions in colon can prevent the
      development of colon cancer.

      The classic endoscopic mucosal resection technique and the submucosal dissection technique
      require the creation of a submucosal "cushion" by injecting crystalloid substances or
      colloids. However, these advanced techniques have technical limitations when facing a lesion
      that presents poor lifting or non-lifting at all as it might be observed in scarring or
      fibrotic lesions

      Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC)
      is a recent technique that does not require the injection of a submucosal solution and allows
      a resection of colonic lesions of up to approximately 30 mm, en bloc, allowing a correct
      histological study of the sample, to confirm its complete resection with adequate deep
      margins, evaluation of the level of invasion and lymphovascular involvement.

      EFTR with OTSC allows a colonic wall full-thickness resection, by the deployment of an
      over-the-scope clip before the resection of the lesion to prevent perforation. The steps of
      the technique are: face the lesion and marking the borders, insertion of the scope with the
      kit (consisting of a cap with an integrated snare and OTSC), grasping and pulling the lesion
      into the cap, deploy the over-the-scope-clip (OTSC) and closing the integrated snare and
      resect.

      This is a multicenter observational study on the efficacy and safety of EFTR with OTSC in
      colon.

      The clinical, endoscopic and histological data are collected prospectively in all cases of
      EFTR performed in the participant centers.
observational model: Cohort
time perspective: Prospective
measure: Technical Success
time frame: Through study completion, an average of 1 year
description: Percentage of complete en-bloc resection of the lesion without macroscopic residual tissue after completing the endoscopic full-thickness resection
measure: Major adverse events
time frame: 3 months
description: Percentage of procedure-associated major adverse events: bleeding and/or perforation
measure: Histologically confirmed full-thickness resection
time frame: 30 days
description: Histologically confirmed full-thickness resection
arm group label: Endoscopic full-thickness resection
description: Patients with neoplastic lesions less than 30mm unresectable en bloc by other less invasive endoscopic techniques, including lesions suggestive of T1 colorectal cancer, subepithelial tumors, lesions with diverticular involvement, lesions with no-lifting sign (recurrent, incomplete prior resection or untreated lesions).
intervention type: Procedure
intervention name: Endoscopic full-thickness resection
description: Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions
arm group label: Endoscopic full-thickness resection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hugo I. Uchima Koecklin, MD
role: Principal Investigator
affiliation: Medical researcher
last name: Hugo I. Uchima Koecklin, MD
phone: +34 934978866
email: hugoikuo@gmail.com
last name: Magin Farré Albadalejo
email: mfarre.germanstrias@gencat.cat
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country: Spain
citation: Schmidt A, Meier B, Caca K. Endoscopic full-thickness resection: Current status. World J Gastroenterol. 2015 Aug 21;21(31):9273-85. doi: 10.3748/wjg.v21.i31.9273.
PMID: 26309354
citation: Uchima H, Barquero D, Fernandez A, Mata A, Huertas C, Figa M, Hombrados M, Espinos JC. Su1638 Early Discharge After Endoscopic Full-Thickness Resection in the Colorectum. Gastrointest Endosc. 2017;85:5, AB375
citation: Schmidt A, Beyna T, Schumacher B, Meining A, Richter-Schrag HJ, Messmann H, Neuhaus H, Albers D, Birk M, Thimme R, Probst A, Faehndrich M, Frieling T, Goetz M, Riecken B, Caca K. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut. 2018 Jul;67(7):1280-1289. doi: 10.1136/gutjnl-2016-313677. Epub 2017 Aug 10.
PMID: 28798042
citation: Backes Y, Kappelle WFW, Berk L, Koch AD, Groen JN, de Vos Tot Nederveen Cappel WH, Schwartz MP, Kerkhof M, Siersema PD, Schroder R, Tan TG, Lacle MM, Vleggaar FP, Moons LMG; T1 CRC Working Group. Colorectal endoscopic full-thickness resection using a novel, flat-base over-the-scope clip: a prospective study. Endoscopy. 2017 Nov;49(11):1092-1097. doi: 10.1055/s-0043-114730. Epub 2017 Jul 28.
PMID: 28753696
responsible party type: Principal Investigator
investigator affiliation: Fundació Institut Germans Trias i Pujol
investigator full name: HugoUchima
investigator title: Medical Specialist (gastroenterologist, MD)
mesh term: Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Adenoma
mesh term: Colonic Neoplasms
sharing ipd: No