<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/NCT03247231</url>
  </required_header>
  <id_info>
    <org_study_id>BANDING-SET</org_study_id>
    <nct_id>NCT03247231</nct_id>
  </id_info>
  <brief_title>Banding Without Resection in Small Subepithelial Tumours</brief_title>
  <acronym>BANDING-SET</acronym>
  <official_title>Effectiveness and Safety of the Endoscopic Band Ligation Without Resection of ≤15-mm Subepithelial Tumours of the Digestive Tract: a Multicenter Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joan B Gornals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari de Bellvitge</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To analyse the effectiveness and safety of endoscopic band ligation without resection in&#xD;
      small gastrointestinal subepithelial tumours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multicenter prospective study analysing the effectiveness and safety of endoscopic band&#xD;
      ligation without resection in small (≤15-mm) gastrointestinal subepithelial tumours.&#xD;
&#xD;
      This endoscopic technique will be complemented with a SINK (single-incision needle-knife)&#xD;
      biopsy for ensuring the pathological diagnosis of the treated subepithelial tumour.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to SARS-CoV2 (Covid-19) pandemia&#xD;
  </why_stopped>
  <start_date type="Actual">March 31, 2017</start_date>
  <completion_date type="Actual">March 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 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>Removal of the subepithelial tumour (initial clinical success).</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Complete removal and disappearance of the subepithelial tumour at 4-6 weeks by endoscopic ultrasonography control.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Removal of the subepithelial tumour (global clinical success).</measure>
    <time_frame>1 year</time_frame>
    <description>Complete removal and disappearance of the subepithelial tumour at 1 year by endoscopic ultrasonography control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by American Society of Gastrointestinal Endoscopy (ASGE) guideline.</measure>
    <time_frame>1 year</time_frame>
    <description>Incidence of treatment-emergent adverse events, graded by American Society of Gastrointestinal Endoscopy (ASGE) guideline (Ref: Cooton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010;71:446-54).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success.</measure>
    <time_frame>First day</time_frame>
    <description>Correct application of elastic banding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SINK biopsy efectiveness.</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Positive definitve pathological result rate of single-incision needle-knife (SINK) biopsies permorfed in subeptihelial tumours ligated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term recurrence.</measure>
    <time_frame>5 years</time_frame>
    <description>Recurrence of indeterminate or pre-malignant subepithelial tumours rate at 5 years by endoscopic ultrasonography control.</description>
  </secondary_outcome>
  <enrollment type="Actual">157</enrollment>
  <condition>Gastrointestinal Subepithelial Tumors</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endoscopic band ligation without resection</intervention_name>
    <description>Endoscopic treatment of subepithelial tumors: autoamputation by endoscopic band ligation without resection.</description>
    <other_name>Endoscopic ligation</other_name>
    <other_name>Endoscopic band ligation without electrosurgery</other_name>
    <other_name>Band ligation with a mucosectomy device without resection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SINK</intervention_name>
    <description>To obtain sample tissue biopsies after the endoscopic band ligation without resection, performing a single-incision with a needle-knife.</description>
    <other_name>Single-incision needle-knife</other_name>
    <other_name>Single-incision needle-knife and use of a biopsy forceps device</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with subepithelial lesions (SEL) in the gastrointestinal tract.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
          -  Age between 18 and 80 years old.&#xD;
&#xD;
          -  Endoscopic ultrasound (EUS) image of a gastrointestinal subepithelial tumour (SET)&#xD;
             ≤15-mm.&#xD;
&#xD;
          -  Patient capable of understanding and signing informed consent form.&#xD;
&#xD;
          -  Patient understanding the type of study and complying with the follow-up of&#xD;
             complementary tests during the study duration.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  SETs &gt;15-mm.&#xD;
&#xD;
          -  SETs with clear diagnosis of EUS benign semiology: ie., lipoma, ectopic pancreas.&#xD;
&#xD;
          -  Patients with multiple SETs (e.g., carcinoids).&#xD;
&#xD;
          -  Vascular SETs (Doppler effect by EUS).&#xD;
&#xD;
          -  Severe coagulation disorder: INR &gt;1.5 not correctible with administration of plasma&#xD;
             and/or platelets &lt;50,000/mm3.&#xD;
&#xD;
          -  Conditions that preclude upper digestive endoscopy, such as stenosis.&#xD;
&#xD;
          -  Pregnancy or breast-feeding.&#xD;
&#xD;
          -  Failure to sign informed consent form.&#xD;
&#xD;
          -  Patients with functional diversity who are unable to understand the nature and&#xD;
             possible consequences of the study, unless there is a competent legal representative.&#xD;
&#xD;
          -  Patients unable to adhere to subsequent follow-up requirements.&#xD;
&#xD;
          -  Patients with a life expectancy of less than 12 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joan B Gornals, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francesc Bas-Cutrina, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol (Can Ruti)</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona, Catalonia</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona, Catalonia</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Mútua de Terrassa</name>
      <address>
        <city>Terrassa</city>
        <state>Barcelona, Catalonia</state>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Sant Pau i de la Santa Creu</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Girona Doctor Josep Trueta</name>
      <address>
        <city>Girona</city>
        <state>Catalonia</state>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Arnau de Vilanova de Lleida</name>
      <address>
        <city>Lleida</city>
        <state>Catalonia</state>
        <zip>25198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Joan XXIII de Tarragona</name>
      <address>
        <city>Tarragona</city>
        <state>Catalonia</state>
        <zip>43005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Bas-Cutrina F, Consiglieri CF, Bosch-Schips J, Gornals JB. Endoscopic band ligation plus single-incision needle knife biopsy for small subepithelial deep-layer tumor: easy and effective. Endoscopy. 2019 Jul;51(7):E191-E192. doi: 10.1055/a-0875-3958. Epub 2019 Apr 12. No abstract available.</citation>
    <PMID>30978731</PMID>
  </reference>
  <reference>
    <citation>Standards of Practice Committee; Faulx AL, Kothari S, Acosta RD, Agrawal D, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Gurudu SR, Khashab MA, Lightdale JR, Muthusamy VR, Shaukat A, Qumseya BJ, Wang A, Wani SB, Yang J, DeWitt JM. The role of endoscopy in subepithelial lesions of the GI tract. Gastrointest Endosc. 2017 Jun;85(6):1117-1132. doi: 10.1016/j.gie.2017.02.022. Epub 2017 Apr 3. No abstract available.</citation>
    <PMID>28385194</PMID>
  </reference>
  <reference>
    <citation>ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12.</citation>
    <PMID>26077453</PMID>
  </reference>
  <reference>
    <citation>Song JH, Kim SG, Chung SJ, Kang HY, Yang SY, Kim YS. Risk of progression for incidental small subepithelial tumors in the upper gastrointestinal tract. Endoscopy. 2015 Aug;47(8):675-9. doi: 10.1055/s-0034-1391967. Epub 2015 May 11.</citation>
    <PMID>25961444</PMID>
  </reference>
  <reference>
    <citation>de la Serna-Higuera C, Perez-Miranda M, Diez-Redondo P, Gil-Simon P, Herranz T, Perez-Martin E, Ochoa C, Caro-Paton A. EUS-guided single-incision needle-knife biopsy: description and results of a new method for tissue sampling of subepithelial GI tumors (with video). Gastrointest Endosc. 2011 Sep;74(3):672-6. doi: 10.1016/j.gie.2011.05.042.</citation>
    <PMID>21872716</PMID>
  </reference>
  <reference>
    <citation>Binmoeller KF, Shah JN, Bhat YM, Kane SD. Suck-ligate-unroof-biopsy by using a detachable 20-mm loop for the diagnosis and therapy of small subepithelial tumors (with video). Gastrointest Endosc. 2014 May;79(5):750-5. doi: 10.1016/j.gie.2013.09.028. Epub 2013 Nov 12. Erratum In: Gastrointest Endosc. 2014 Jul;80(1):196.</citation>
    <PMID>24238309</PMID>
  </reference>
  <reference>
    <citation>Ibanez-Sanz G, Gornals JB, Rivas L, Salord S, Paules MJ, Botargues JM, Galan M. Endoscopic band ligation without resection in selected patients for small and superficial upper gastrointestinal tract lesions. Rev Esp Enferm Dig. 2016 May;108(5):250-6. doi: 10.17235/reed.2016.4031/2015.</citation>
    <PMID>27022723</PMID>
  </reference>
  <reference>
    <citation>Bas-Cutrina F, Ballester-Clau R, Gonzalez-Huix F, Gornals JB. Gastric perforation during ligation-assisted endoscopic mucosal resection of a neuroendocrine tumor: banding without resection may be a safer option. Endoscopy. 2020 Oct;52(10):E370-E371. doi: 10.1055/a-1134-4742. Epub 2020 Mar 27. No abstract available.</citation>
    <PMID>32219785</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>March 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>September 3, 2022</last_update_submitted>
  <last_update_submitted_qc>September 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitari de Bellvitge</investigator_affiliation>
    <investigator_full_name>Joan B Gornals</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Endoscopic ultrasound</keyword>
  <keyword>Small gastrointestinal subepithelial tumours</keyword>
  <keyword>Endoscopic band ligation without resection</keyword>
  <keyword>Single-incision needle-knife biopsy</keyword>
  <keyword>Pre-cancerous tumours</keyword>
  <keyword>Multicenter observational cohort study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03247231
org study id: BANDING-SET
nct id: NCT03247231
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To analyse the effectiveness and safety of endoscopic band ligation without resection in
      small gastrointestinal subepithelial tumours.
Multicenter prospective study analysing the effectiveness and safety of endoscopic band
      ligation without resection in small (≤15-mm) gastrointestinal subepithelial tumours.

      This endoscopic technique will be complemented with a SINK (single-incision needle-knife)
      biopsy for ensuring the pathological diagnosis of the treated subepithelial tumour.
observational model: Cohort
time perspective: Prospective
measure: Removal of the subepithelial tumour (initial clinical success).
time frame: 4-6 weeks
description: Complete removal and disappearance of the subepithelial tumour at 4-6 weeks by endoscopic ultrasonography control.
measure: Removal of the subepithelial tumour (global clinical success).
time frame: 1 year
description: Complete removal and disappearance of the subepithelial tumour at 1 year by endoscopic ultrasonography control.
measure: Number of participants with treatment-related adverse events as assessed by American Society of Gastrointestinal Endoscopy (ASGE) guideline.
time frame: 1 year
description: Incidence of treatment-emergent adverse events, graded by American Society of Gastrointestinal Endoscopy (ASGE) guideline (Ref: Cooton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010;71:446-54).
measure: Technical success.
time frame: First day
description: Correct application of elastic banding.
measure: SINK biopsy efectiveness.
time frame: 4-6 weeks
description: Positive definitve pathological result rate of single-incision needle-knife (SINK) biopsies permorfed in subeptihelial tumours ligated.
measure: Long-term recurrence.
time frame: 5 years
description: Recurrence of indeterminate or pre-malignant subepithelial tumours rate at 5 years by endoscopic ultrasonography control.
intervention type: Device
intervention name: Endoscopic band ligation without resection
description: Endoscopic treatment of subepithelial tumors: autoamputation by endoscopic band ligation without resection.
other name: Endoscopic ligation
other name: Endoscopic band ligation without electrosurgery
other name: Band ligation with a mucosectomy device without resection
intervention type: Procedure
intervention name: SINK
description: To obtain sample tissue biopsies after the endoscopic band ligation without resection, performing a single-incision with a needle-knife.
other name: Single-incision needle-knife
other name: Single-incision needle-knife and use of a biopsy forceps device
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Joan B Gornals, MD, PhD
role: Principal Investigator
affiliation: Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
last name: Francesc Bas-Cutrina, MD
role: Principal Investigator
affiliation: Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
citation: Bas-Cutrina F, Consiglieri CF, Bosch-Schips J, Gornals JB. Endoscopic band ligation plus single-incision needle knife biopsy for small subepithelial deep-layer tumor: easy and effective. Endoscopy. 2019 Jul;51(7):E191-E192. doi: 10.1055/a-0875-3958. Epub 2019 Apr 12. No abstract available.
PMID: 30978731
citation: Standards of Practice Committee; Faulx AL, Kothari S, Acosta RD, Agrawal D, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Gurudu SR, Khashab MA, Lightdale JR, Muthusamy VR, Shaukat A, Qumseya BJ, Wang A, Wani SB, Yang J, DeWitt JM. The role of endoscopy in subepithelial lesions of the GI tract. Gastrointest Endosc. 2017 Jun;85(6):1117-1132. doi: 10.1016/j.gie.2017.02.022. Epub 2017 Apr 3. No abstract available.
PMID: 28385194
citation: ASGE Technology Committee; Hwang JH, Konda V, Abu Dayyeh BK, Chauhan SS, Enestvedt BK, Fujii-Lau LL, Komanduri S, Maple JT, Murad FM, Pannala R, Thosani NC, Banerjee S. Endoscopic mucosal resection. Gastrointest Endosc. 2015 Aug;82(2):215-26. doi: 10.1016/j.gie.2015.05.001. Epub 2015 Jun 12.
PMID: 26077453
citation: Song JH, Kim SG, Chung SJ, Kang HY, Yang SY, Kim YS. Risk of progression for incidental small subepithelial tumors in the upper gastrointestinal tract. Endoscopy. 2015 Aug;47(8):675-9. doi: 10.1055/s-0034-1391967. Epub 2015 May 11.
PMID: 25961444
citation: de la Serna-Higuera C, Perez-Miranda M, Diez-Redondo P, Gil-Simon P, Herranz T, Perez-Martin E, Ochoa C, Caro-Paton A. EUS-guided single-incision needle-knife biopsy: description and results of a new method for tissue sampling of subepithelial GI tumors (with video). Gastrointest Endosc. 2011 Sep;74(3):672-6. doi: 10.1016/j.gie.2011.05.042.
PMID: 21872716
citation: Binmoeller KF, Shah JN, Bhat YM, Kane SD. Suck-ligate-unroof-biopsy by using a detachable 20-mm loop for the diagnosis and therapy of small subepithelial tumors (with video). Gastrointest Endosc. 2014 May;79(5):750-5. doi: 10.1016/j.gie.2013.09.028. Epub 2013 Nov 12. Erratum In: Gastrointest Endosc. 2014 Jul;80(1):196.
PMID: 24238309
citation: Ibanez-Sanz G, Gornals JB, Rivas L, Salord S, Paules MJ, Botargues JM, Galan M. Endoscopic band ligation without resection in selected patients for small and superficial upper gastrointestinal tract lesions. Rev Esp Enferm Dig. 2016 May;108(5):250-6. doi: 10.17235/reed.2016.4031/2015.
PMID: 27022723
citation: Bas-Cutrina F, Ballester-Clau R, Gonzalez-Huix F, Gornals JB. Gastric perforation during ligation-assisted endoscopic mucosal resection of a neuroendocrine tumor: banding without resection may be a safer option. Endoscopy. 2020 Oct;52(10):E370-E371. doi: 10.1055/a-1134-4742. Epub 2020 Mar 27. No abstract available.
PMID: 32219785
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Universitari de Bellvitge
investigator full name: Joan B Gornals
investigator title: Principal investigator
mesh term: Neoplasms
sharing ipd: Undecided