<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/NCT01688687</url>
  </required_header>
  <id_info>
    <org_study_id>MD-2012-01</org_study_id>
    <nct_id>NCT01688687</nct_id>
  </id_info>
  <brief_title>Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia</brief_title>
  <acronym>pCLE</acronym>
  <official_title>The Accuracy of Probe-based Confocal Endomicroscopy Versus Conventional Biopsies for the Diagnosis of Superficial Gastric Neoplasias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soonchunhyang University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soonchunhyang University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification&#xD;
      imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous&#xD;
      studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal&#xD;
      polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are&#xD;
      limited data exploring the application of pCLE to gastric lesions, and this is the first&#xD;
      study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the&#xD;
      final specimens obtained from endoscopic resection as a reference standard. The aims of this&#xD;
      study were (1) the accuracy of pCLE compared to conventional forceps biopsy using&#xD;
      histopathology results following endoscopic resection as a reference, and (2) comparison of&#xD;
      &quot;real time&quot; in-vivo pCLE diagnosis with that of blinded &quot;off-line&quot; pCLE diagnosis, and&#xD;
      off-line interobserver agreement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>The accuracy of pCLE compared to conventional forceps biopsy</measure>
    <time_frame>in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection.</time_frame>
    <description>The accuracy of pCLE compared to conventional forceps biopsy was assessed using histopathology results following endoscopic resection as a reference</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of &quot;real time&quot; in-vivo pCLE diagnosis with that of blinded &quot;off-line&quot; pCLE diagnosis.</measure>
    <time_frame>1-3 months after endoscopic resection and final histopathological analysis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Off-line pCLE interobserver agreement</measure>
    <time_frame>1-3 months after endoscopic resection and final histopathological analysis</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">63</enrollment>
  <condition>Early Gastric Cancer</condition>
  <condition>Gastric Dysplasia</condition>
  <arm_group>
    <arm_group_label>Superficial gastric neoplasia</arm_group_label>
    <description>Patients with superficial gastric neoplasia on diagnostic endoscopy, recieved both conventional endoscopic forcpes biopsies and pCLE. All patients were subject to endoscopic resection of the lesion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic submucosal dissection</intervention_name>
    <arm_group_label>Superficial gastric neoplasia</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Endscopic resection specimens of gastric neoplasia. Speciments were obtained either by&#xD;
      endoscopic mucosal resection or endoscopic submucosal dissection.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients referred to a tertiary medical center for endoscopic resection of&#xD;
        gastric superficial lesions.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with biospy proven superficial gastric neoplasia, suitable for endoscopic&#xD;
             resection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with uncorrectable coagulopathy,&#xD;
&#xD;
          -  liver cirrhosis,&#xD;
&#xD;
          -  acute gastrointestinal bleeding,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  breast feeding,&#xD;
&#xD;
          -  documented allergy to fluorescein,&#xD;
&#xD;
          -  patients with lesions that were deemed unsuitable for endoscopic resection, and&#xD;
&#xD;
          -  patients without documented conventional biopsy results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Soonchunhyang University Seoul Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>140-743</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Wallace M, Lauwers GY, Chen Y, Dekker E, Fockens P, Sharma P, Meining A. Miami classification for probe-based confocal laser endomicroscopy. Endoscopy. 2011 Oct;43(10):882-91. doi: 10.1055/s-0030-1256632. Epub 2011 Aug 4.</citation>
    <PMID>21818734</PMID>
  </results_reference>
  <results_reference>
    <citation>Jeon SR, Cho WY, Jin SY, Cheon YK, Choi SR, Cho JY. Optical biopsies by confocal endomicroscopy prevent additive endoscopic biopsies before endoscopic submucosal dissection in gastric epithelial neoplasias: a prospective, comparative study. Gastrointest Endosc. 2011 Oct;74(4):772-80. doi: 10.1016/j.gie.2011.05.005. Epub 2011 Jul 29.</citation>
    <PMID>21802680</PMID>
  </results_reference>
  <results_reference>
    <citation>Shahid MW, Buchner AM, Raimondo M, Woodward TA, Krishna M, Wallace MB. Accuracy of real-time vs. blinded offline diagnosis of neoplastic colorectal polyps using probe-based confocal laser endomicroscopy: a pilot study. Endoscopy. 2012 Apr;44(4):343-8. doi: 10.1055/s-0031-1291589. Epub 2012 Mar 1.</citation>
    <PMID>22382851</PMID>
  </results_reference>
  <results_reference>
    <citation>Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28.</citation>
    <PMID>22749368</PMID>
  </results_reference>
  <results_reference>
    <citation>Kuiper T, Kiesslich R, Ponsioen C, Fockens P, Dekker E. The learning curve, accuracy, and interobserver agreement of endoscope-based confocal laser endomicroscopy for the differentiation of colorectal lesions. Gastrointest Endosc. 2012 Jun;75(6):1211-7. doi: 10.1016/j.gie.2012.01.040. Epub 2012 Mar 28.</citation>
    <PMID>22459661</PMID>
  </results_reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <last_update_submitted>September 19, 2012</last_update_submitted>
  <last_update_submitted_qc>September 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soonchunhyang University Hospital</investigator_affiliation>
    <investigator_full_name>Gene Hyun Bok</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT01688687
org study id: MD-2012-01
nct id: NCT01688687
lead sponsor: 
has dmc: Yes
Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification
      imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous
      studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal
      polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are
      limited data exploring the application of pCLE to gastric lesions, and this is the first
      study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the
      final specimens obtained from endoscopic resection as a reference standard. The aims of this
      study were (1) the accuracy of pCLE compared to conventional forceps biopsy using
      histopathology results following endoscopic resection as a reference, and (2) comparison of
      "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis, and
      off-line interobserver agreement.
observational model: Cohort
time perspective: Prospective
measure: The accuracy of pCLE compared to conventional forceps biopsy
time frame: in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection.
description: The accuracy of pCLE compared to conventional forceps biopsy was assessed using histopathology results following endoscopic resection as a reference
measure: Comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis.
time frame: 1-3 months after endoscopic resection and final histopathological analysis
measure: Off-line pCLE interobserver agreement
time frame: 1-3 months after endoscopic resection and final histopathological analysis
arm group label: Superficial gastric neoplasia
description: Patients with superficial gastric neoplasia on diagnostic endoscopy, recieved both conventional endoscopic forcpes biopsies and pCLE. All patients were subject to endoscopic resection of the lesion.
intervention type: Procedure
intervention name: Endoscopic submucosal dissection
arm group label: Superficial gastric neoplasia
Endscopic resection specimens of gastric neoplasia. Speciments were obtained either by
      endoscopic mucosal resection or endoscopic submucosal dissection.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
citation: Wallace M, Lauwers GY, Chen Y, Dekker E, Fockens P, Sharma P, Meining A. Miami classification for probe-based confocal laser endomicroscopy. Endoscopy. 2011 Oct;43(10):882-91. doi: 10.1055/s-0030-1256632. Epub 2011 Aug 4.
PMID: 21818734
citation: Jeon SR, Cho WY, Jin SY, Cheon YK, Choi SR, Cho JY. Optical biopsies by confocal endomicroscopy prevent additive endoscopic biopsies before endoscopic submucosal dissection in gastric epithelial neoplasias: a prospective, comparative study. Gastrointest Endosc. 2011 Oct;74(4):772-80. doi: 10.1016/j.gie.2011.05.005. Epub 2011 Jul 29.
PMID: 21802680
citation: Shahid MW, Buchner AM, Raimondo M, Woodward TA, Krishna M, Wallace MB. Accuracy of real-time vs. blinded offline diagnosis of neoplastic colorectal polyps using probe-based confocal laser endomicroscopy: a pilot study. Endoscopy. 2012 Apr;44(4):343-8. doi: 10.1055/s-0031-1291589. Epub 2012 Mar 1.
PMID: 22382851
citation: Wallace MB, Crook JE, Saunders M, Lovat L, Coron E, Waxman I, Sharma P, Hwang JH, Banks M, DePreville M, Galmiche JP, Konda V, Diehl NN, Wolfsen HC. Multicenter, randomized, controlled trial of confocal laser endomicroscopy assessment of residual metaplasia after mucosal ablation or resection of GI neoplasia in Barrett's esophagus. Gastrointest Endosc. 2012 Sep;76(3):539-47.e1. doi: 10.1016/j.gie.2012.05.004. Epub 2012 Jun 28.
PMID: 22749368
citation: Kuiper T, Kiesslich R, Ponsioen C, Fockens P, Dekker E. The learning curve, accuracy, and interobserver agreement of endoscope-based confocal laser endomicroscopy for the differentiation of colorectal lesions. Gastrointest Endosc. 2012 Jun;75(6):1211-7. doi: 10.1016/j.gie.2012.01.040. Epub 2012 Mar 28.
PMID: 22459661
responsible party type: Principal Investigator
investigator affiliation: Soonchunhyang University Hospital
investigator full name: Gene Hyun Bok
investigator title: M.D.
mesh term: Neoplasms