<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/NCT02238938</url>
  </required_header>
  <id_info>
    <org_study_id>PERLA</org_study_id>
    <secondary_id>PV 4580</secondary_id>
    <nct_id>NCT02238938</nct_id>
  </id_info>
  <brief_title>Piecemeal Versus En Bloc Resection of Large Rectal Adenomas</brief_title>
  <acronym>PERLA</acronym>
  <official_title>Piecemeal Versus En Bloc Resection of Large Rectal Adenomas -A Prospective, Randomized Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, colonoscopy is the safest way to detect bowel tumors and polyps, since these can&#xD;
      be biopsied and removed in one working process. If the size of adenomas is larger than 2 cm,&#xD;
      resections are usually done in a hospital setting. For the resection of large adenomas,&#xD;
      different approaches can be used. The so-called piecemeal resection is done with snares, to&#xD;
      cut off parts of the adenoma piece by piece until the whole adenoma is resected. This&#xD;
      technique is the standard therapy, but is not required for very large adenomas, which can&#xD;
      often show cell alterations that indicate cancer. Therefore these adenomas should be resected&#xD;
      in one piece. This is done by the so-called en-bloc resection. For this kind of therapy,&#xD;
      different endoscopic knifes are use to cut off the adenoma as a whole. Both resection&#xD;
      techniques are done usually by previous injection of saline or other liquids to elevate the&#xD;
      lesion from its bottom tissue.&#xD;
&#xD;
      Although the piecemeal resection of large adenoma is the standard therapy, it shows&#xD;
      recurrence rates of 10 to 25%, which afford repeated therapies and follow up controls.&#xD;
      En-bloc resections, though, are expected to have less recurrence rates but are much more&#xD;
      complex to perform. They have higher complication rates especially in the West, where it has&#xD;
      bee introduced only a couple of years ago.&#xD;
&#xD;
      The data situation regarding safety and efficacy of both therapies is low. This study is the&#xD;
      first one ever to compare piecemeal EMR and ESD in a randomized way. The study might have&#xD;
      influence on the logistics of future adenoma processing and patient flow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 20 to 35% of colonoscopies due to symptoms or for prevention polyps, so-called adenoma,&#xD;
      are found. Currently, colonoscopy is the best way to detect bowel tumors and polyps, since&#xD;
      these can be biopsied and removed in one working process. If the size of adenoma is larger&#xD;
      than 2 cm, resections are usually done in a hospital setting. Foremost for flat adenoma, the&#xD;
      resection by snares piece by piece, the so-called piecemeal polypectomy, or piecemeal&#xD;
      endoscopic mucosal resection (EMR), is state of the art. Resection will usually follow a&#xD;
      submucosal saline injection (saline assisted polypectomy). Recurrences occur in 10 up to 25&#xD;
      %, requiring a reapplication of endoscopic therapy and follow up examinations.&#xD;
&#xD;
      Depending on the size of adenoma, increasing amounts of cell alterations of an advanced stage&#xD;
      such as high grade dysplasia / intraepithelial neoplasia (HGIN) up to early cancer are found.&#xD;
      In these cases, for histo-pathological and oncological reasons, a resection in a solitary&#xD;
      manner (en-bloc resection) is necessary to evaluate the completeness of resection properly.&#xD;
      Also, former studies showed that recurrence rate could be decreased considerably by en-bloc&#xD;
      resections, since the aim is to perform a complete resection basally and laterally. New&#xD;
      endoscopic techniques of en-bloc resections have been introduced since a couple of years,&#xD;
      using several endoscopic knifes to cut adenoma down after submucosal injection of liquid and&#xD;
      consecutively dissect it from the tissue underneath. This technique is mostly called&#xD;
      endoscopic submucosal dissection (ESD), and, with not too large adenoma, can be combined with&#xD;
      snare resection, too. The complexity of this method though is much larger than that of snare&#xD;
      resection. Therefore, the western success rate is considerably less than in Japan, where it&#xD;
      was developed first, and where higher numbers of cases exist in the upper GI tract as well as&#xD;
      in the lower GI tract. All in all, the complication rate of en-bloc resection is higher than&#xD;
      that of snare resection. Those complications, mostly perforations, are endoscopically&#xD;
      controllable in most cases, though.&#xD;
&#xD;
      In comparison with Japan, Korea or China, early malign lesions oft he upper GI tract in the&#xD;
      West are rare. Therefore, this study will be conducted on (colo)rectal lesions, which appear&#xD;
      much more often in the West.&#xD;
&#xD;
      All in all, for efficacy (resection in total, number of recurrences) and risk (perforations),&#xD;
      there is an indistinct data situation between piecemeal resection (EMR) and en-bloc resection&#xD;
      (ESD). Up to now, no randomised comparing data exist. The planned study is the first&#xD;
      randomised study between ESD and piecemeal EMR at all, since there are no studies been done&#xD;
      for the upper GI tract, either. For reasons of complexity, ESD will conceivably remain a&#xD;
      method for specialized centers, while piecemeal polypectomies are done in numerous hospitals.&#xD;
      Therefore, the outcomes of this study will have influence on future logistics in&#xD;
      polypectomies and flow of patients with large colorectal adenoma.&#xD;
&#xD;
      Piecemeal resection will be done by snare following marking and submucosal injection of&#xD;
      saline or equivalent liquids. Small leftover adenoma tissue will be resected thoroughly by&#xD;
      snare or forceps. High resolution endoscopes are mandatory.&#xD;
&#xD;
      After three months, an Argon plasma coagulation (APC) therapy will follow any piecemeal&#xD;
      resection, if necessary, another resection of leftover adenoma will be done. This second&#xD;
      session can be done by sigmoidoscopy.&#xD;
&#xD;
      En- bloc resection is done after marking by use of different customary endoscopic knifes&#xD;
      including combining devices as hybrid knife to cut down the lesion. After submucosal&#xD;
      injection of liquid (saline or equivalent) to elevate the tissue it will be dissected and&#xD;
      removed by a snare of adequate size solitarily. Since the aim of this method is the total&#xD;
      resection basally and laterally, only one session is intended.&#xD;
&#xD;
      Follow-up care: sigmoidoscopy after 6 and 18 months, colonoscopy after 36 months each after&#xD;
      the end of the primary therapy session(s). Diagnostics will be done endoscopically and&#xD;
      histologically of at least 6 biopsies if the size of lesion was up to 3 cm, and of at least&#xD;
      10 biopsies for larger lesions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    insufficient recruitment of study patients&#xD;
  </why_stopped>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">May 30, 2022</completion_date>
  <primary_completion_date type="Actual">May 30, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>success rate of complete resection</measure>
    <time_frame>6 and 18 months after primary therapy</time_frame>
    <description>success rate is confirmed by endoscopical diagnostics as well as histological diagnostics (at lest 6 biopsies in lesions up to 3 cm size, at least 10 biopsies in larger lesions). Patients with no complete resection will be treated further according to clinical requirement, depending on histology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>en-bloc group: rate of R0 resections</measure>
    <time_frame>timeline 0, day of en-bloc resection</time_frame>
    <description>This parameter is regarding histopathology. Since piecemeal resections do not allow such a diagnosis, this parameter is only for the en-bloc resected group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrence rate after complete adenoma resection</measure>
    <time_frame>36 months after initial resection</time_frame>
    <description>Since early recurrences can evolve from leftover tumor cells and will become manifest after a time, the third control after two controls with negative biopsies.has been chosen to be the gold standard.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progress of therapy in patients with incomplete resection and recurrences</measure>
    <time_frame>36 months after initial resection</time_frame>
    <description>patients will be treated further according to treatment standard depending on endoscopical and histological findings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>differences in the subgroups of adenomas</measure>
    <time_frame>5 years</time_frame>
    <description>size, shape according to nice classification, low-grade and high grade intraepithelial adenomas, sm1 carcinomas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>required time for the initial procedure</measure>
    <time_frame>timeline 0, day of initial resection</time_frame>
    <description>for piecemeal resections including second procedure with APC therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications including success of complication management</measure>
    <time_frame>5 years</time_frame>
    <description>rate of complications that need intervention, e.g.&#xD;
perforation (intra - and post procedural, surgery, additional procedures such as antibiotics, monitoring, intensive care&#xD;
secondary haemorrhage (second look endoscopy, surgery)&#xD;
infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications through patient sedation</measure>
    <time_frame>timeline 0, day of initial resection</time_frame>
    <description>depending on sedation standards of the participating centers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>resolution of tumor board for post resections and outcomes of patients with carcinoma histology</measure>
    <time_frame>5 years</time_frame>
    <description>patients with carcinoma histology will be discussed by a of tumor board</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Colorectal Adenoma With Mild Dysplasia</condition>
  <condition>Colorectal Adenoma With Severe Dysplasia</condition>
  <condition>Colorectal Adenomatous Polyp</condition>
  <condition>Colorectal Low Grade Intraepithelial Neoplasia</condition>
  <condition>Colorectal High Grade Intraepithelial Neoplasia</condition>
  <arm_group>
    <arm_group_label>en-bloc resection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>En- bloc resection is done after marking by use of different customary endoscopic knifes including combining devices as hybrid knife to cut down the lesion. After submucosal injection of liquid (saline or equivalent) to elevate the tissue it will be dissected and removed by a snare of adequate size solitarily. Since the aim of this method is the total resection basally and laterally, only one session is intended.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>piecemeal resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Piecemeal resection will be done by snare following marking and submucosal injection of saline or equivalent liquids. Small leftover adenoma tissue will be resected thoroughly by snare or forceps. High resolution endoscopes are mandatory.&#xD;
After three months, an APC therapy will follow any piecemeal resection, if necessary, another resection of leftover adenoma will be done. This second session can be done by sigmoidoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>en-bloc resection</intervention_name>
    <description>En- bloc resection after marking by use of different customary endoscopic knifes including combining devices as hybrid knife to cut down the lesion. After submucosal injection of liquid (saline or equivalent) to elevate the tissue it will be dissected and removed by a snare of adequate size solitarily.</description>
    <arm_group_label>en-bloc resection</arm_group_label>
    <other_name>endoscopic submucosal dissection</other_name>
    <other_name>ESD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>piecemeal resection</intervention_name>
    <description>Piecemeal resection is done by snare after marking and submucosal injection of saline or equivalent liquids. Small leftover adenoma tissue will be resected thoroughly by snare or forceps.&#xD;
After three months, an APC therapy will follow any piecemeal resection, if necessary, another resection of leftover adenoma will be done.</description>
    <arm_group_label>piecemeal resection</arm_group_label>
    <other_name>piecemeal polypectomy</other_name>
    <other_name>piecemeal endoscopic mucosal resection</other_name>
    <other_name>piecemeal EMR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with large non pedunculated colorectal adenomas designated for endoscopic&#xD;
             resection up to 15 cm ab ano, length 2 cm to 5 cm, maximum hemicircumferential&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  signed Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  adenomas smaller or larger than described above&#xD;
&#xD;
          -  more than one large rectal adenoma&#xD;
&#xD;
          -  adenomas with known or suspected carcinoma, proven by previous biopsies&#xD;
&#xD;
          -  adenomas with known or suspected carcinoma that do not seem to be resectable by&#xD;
             endoscopy, e.g. ulcers, suspected infiltration of submucosa after endoscopic or&#xD;
             ultrasound diagnostics&#xD;
&#xD;
          -  patients with chronic inflammatory bowel diseases&#xD;
&#xD;
          -  severe general disease, including metastasising carcinomas&#xD;
&#xD;
          -  coagulation abnormalities or anticoagulant drug use which make resection therapy&#xD;
             impossible&#xD;
&#xD;
          -  bad general state of health (American Society of Anesthesiologists Classification&#xD;
             (ASA) IV or more)&#xD;
&#xD;
          -  pregnancy and lactation&#xD;
&#xD;
          -  recurrence or leftover dysplasia after extended endoscopic or surgical therapy&#xD;
             (transanal endoscopic microsurgery (TEM))&#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>Thomas Rösch, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Eppendorf, Hamburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sana Klinikum Lichtenberg</name>
      <address>
        <city>Berlin</city>
        <zip>10365</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Wenckebach-Klinikum</name>
      <address>
        <city>Berlin</city>
        <zip>12099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Bernward Krankenhaus</name>
      <address>
        <city>Hildesheim</city>
        <zip>31134</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Barmherzige Brüder Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93049</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Portsmouth Hospitals NHS Trust</name>
      <address>
        <city>Portsmouth</city>
        <zip>Havant PO9 5NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United Kingdom</country>
  </location_countries>
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  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsklinikum Hamburg-Eppendorf</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Thomas Rösch</investigator_full_name>
    <investigator_title>Clinical Director, Department of Interdisciplinary Endoscopy</investigator_title>
  </responsible_party>
  <keyword>piecemeal polypectomy</keyword>
  <keyword>piecemeal endoscopic mucosal resection (EMR)</keyword>
  <keyword>endoscopic submucosal dissection (ESD)</keyword>
  <keyword>endoscopic en-bloc resection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Adenomatous Polyps</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/NCT02238938
org study id: PERLA
secondary id: PV 4580
nct id: NCT02238938
lead sponsor: 
has dmc: No
Currently, colonoscopy is the safest way to detect bowel tumors and polyps, since these can
      be biopsied and removed in one working process. If the size of adenomas is larger than 2 cm,
      resections are usually done in a hospital setting. For the resection of large adenomas,
      different approaches can be used. The so-called piecemeal resection is done with snares, to
      cut off parts of the adenoma piece by piece until the whole adenoma is resected. This
      technique is the standard therapy, but is not required for very large adenomas, which can
      often show cell alterations that indicate cancer. Therefore these adenomas should be resected
      in one piece. This is done by the so-called en-bloc resection. For this kind of therapy,
      different endoscopic knifes are use to cut off the adenoma as a whole. Both resection
      techniques are done usually by previous injection of saline or other liquids to elevate the
      lesion from its bottom tissue.

      Although the piecemeal resection of large adenoma is the standard therapy, it shows
      recurrence rates of 10 to 25%, which afford repeated therapies and follow up controls.
      En-bloc resections, though, are expected to have less recurrence rates but are much more
      complex to perform. They have higher complication rates especially in the West, where it has
      bee introduced only a couple of years ago.

      The data situation regarding safety and efficacy of both therapies is low. This study is the
      first one ever to compare piecemeal EMR and ESD in a randomized way. The study might have
      influence on the logistics of future adenoma processing and patient flow.
In 20 to 35% of colonoscopies due to symptoms or for prevention polyps, so-called adenoma,
      are found. Currently, colonoscopy is the best way to detect bowel tumors and polyps, since
      these can be biopsied and removed in one working process. If the size of adenoma is larger
      than 2 cm, resections are usually done in a hospital setting. Foremost for flat adenoma, the
      resection by snares piece by piece, the so-called piecemeal polypectomy, or piecemeal
      endoscopic mucosal resection (EMR), is state of the art. Resection will usually follow a
      submucosal saline injection (saline assisted polypectomy). Recurrences occur in 10 up to 25
      %, requiring a reapplication of endoscopic therapy and follow up examinations.

      Depending on the size of adenoma, increasing amounts of cell alterations of an advanced stage
      such as high grade dysplasia / intraepithelial neoplasia (HGIN) up to early cancer are found.
      In these cases, for histo-pathological and oncological reasons, a resection in a solitary
      manner (en-bloc resection) is necessary to evaluate the completeness of resection properly.
      Also, former studies showed that recurrence rate could be decreased considerably by en-bloc
      resections, since the aim is to perform a complete resection basally and laterally. New
      endoscopic techniques of en-bloc resections have been introduced since a couple of years,
      using several endoscopic knifes to cut adenoma down after submucosal injection of liquid and
      consecutively dissect it from the tissue underneath. This technique is mostly called
      endoscopic submucosal dissection (ESD), and, with not too large adenoma, can be combined with
      snare resection, too. The complexity of this method though is much larger than that of snare
      resection. Therefore, the western success rate is considerably less than in Japan, where it
      was developed first, and where higher numbers of cases exist in the upper GI tract as well as
      in the lower GI tract. All in all, the complication rate of en-bloc resection is higher than
      that of snare resection. Those complications, mostly perforations, are endoscopically
      controllable in most cases, though.

      In comparison with Japan, Korea or China, early malign lesions oft he upper GI tract in the
      West are rare. Therefore, this study will be conducted on (colo)rectal lesions, which appear
      much more often in the West.

      All in all, for efficacy (resection in total, number of recurrences) and risk (perforations),
      there is an indistinct data situation between piecemeal resection (EMR) and en-bloc resection
      (ESD). Up to now, no randomised comparing data exist. The planned study is the first
      randomised study between ESD and piecemeal EMR at all, since there are no studies been done
      for the upper GI tract, either. For reasons of complexity, ESD will conceivably remain a
      method for specialized centers, while piecemeal polypectomies are done in numerous hospitals.
      Therefore, the outcomes of this study will have influence on future logistics in
      polypectomies and flow of patients with large colorectal adenoma.

      Piecemeal resection will be done by snare following marking and submucosal injection of
      saline or equivalent liquids. Small leftover adenoma tissue will be resected thoroughly by
      snare or forceps. High resolution endoscopes are mandatory.

      After three months, an Argon plasma coagulation (APC) therapy will follow any piecemeal
      resection, if necessary, another resection of leftover adenoma will be done. This second
      session can be done by sigmoidoscopy.

      En- bloc resection is done after marking by use of different customary endoscopic knifes
      including combining devices as hybrid knife to cut down the lesion. After submucosal
      injection of liquid (saline or equivalent) to elevate the tissue it will be dissected and
      removed by a snare of adequate size solitarily. Since the aim of this method is the total
      resection basally and laterally, only one session is intended.

      Follow-up care: sigmoidoscopy after 6 and 18 months, colonoscopy after 36 months each after
      the end of the primary therapy session(s). Diagnostics will be done endoscopically and
      histologically of at least 6 biopsies if the size of lesion was up to 3 cm, and of at least
      10 biopsies for larger lesions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: success rate of complete resection
time frame: 6 and 18 months after primary therapy
description: success rate is confirmed by endoscopical diagnostics as well as histological diagnostics (at lest 6 biopsies in lesions up to 3 cm size, at least 10 biopsies in larger lesions). Patients with no complete resection will be treated further according to clinical requirement, depending on histology.
measure: en-bloc group: rate of R0 resections
time frame: timeline 0, day of en-bloc resection
description: This parameter is regarding histopathology. Since piecemeal resections do not allow such a diagnosis, this parameter is only for the en-bloc resected group.
measure: recurrence rate after complete adenoma resection
time frame: 36 months after initial resection
description: Since early recurrences can evolve from leftover tumor cells and will become manifest after a time, the third control after two controls with negative biopsies.has been chosen to be the gold standard.
measure: progress of therapy in patients with incomplete resection and recurrences
time frame: 36 months after initial resection
description: patients will be treated further according to treatment standard depending on endoscopical and histological findings
measure: differences in the subgroups of adenomas
time frame: 5 years
description: size, shape according to nice classification, low-grade and high grade intraepithelial adenomas, sm1 carcinomas
measure: required time for the initial procedure
time frame: timeline 0, day of initial resection
description: for piecemeal resections including second procedure with APC therapy
measure: complications including success of complication management
time frame: 5 years
description: rate of complications that need intervention, e.g.
perforation (intra - and post procedural, surgery, additional procedures such as antibiotics, monitoring, intensive care
secondary haemorrhage (second look endoscopy, surgery)
infection
measure: complications through patient sedation
time frame: timeline 0, day of initial resection
description: depending on sedation standards of the participating centers
measure: resolution of tumor board for post resections and outcomes of patients with carcinoma histology
time frame: 5 years
description: patients with carcinoma histology will be discussed by a of tumor board
arm group label: en-bloc resection
arm group type: Experimental
description: En- bloc resection is done after marking by use of different customary endoscopic knifes including combining devices as hybrid knife to cut down the lesion. After submucosal injection of liquid (saline or equivalent) to elevate the tissue it will be dissected and removed by a snare of adequate size solitarily. Since the aim of this method is the total resection basally and laterally, only one session is intended.
arm group label: piecemeal resection
arm group type: Active Comparator
description: Piecemeal resection will be done by snare following marking and submucosal injection of saline or equivalent liquids. Small leftover adenoma tissue will be resected thoroughly by snare or forceps. High resolution endoscopes are mandatory.
After three months, an APC therapy will follow any piecemeal resection, if necessary, another resection of leftover adenoma will be done. This second session can be done by sigmoidoscopy.
intervention type: Procedure
intervention name: en-bloc resection
description: En- bloc resection after marking by use of different customary endoscopic knifes including combining devices as hybrid knife to cut down the lesion. After submucosal injection of liquid (saline or equivalent) to elevate the tissue it will be dissected and removed by a snare of adequate size solitarily.
arm group label: en-bloc resection
other name: endoscopic submucosal dissection
other name: ESD
intervention type: Procedure
intervention name: piecemeal resection
description: Piecemeal resection is done by snare after marking and submucosal injection of saline or equivalent liquids. Small leftover adenoma tissue will be resected thoroughly by snare or forceps.
After three months, an APC therapy will follow any piecemeal resection, if necessary, another resection of leftover adenoma will be done.
arm group label: piecemeal resection
other name: piecemeal polypectomy
other name: piecemeal endoscopic mucosal resection
other name: piecemeal EMR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Rösch, Prof. Dr.
role: Study Chair
affiliation: University Hospital Eppendorf, Hamburg
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: United Kingdom
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citation: Neuhaus H, Costamagna G, Deviere J, Fockens P, Ponchon T, Rosch T; ARCADE Group. Endoscopic submucosal dissection (ESD) of early neoplastic gastric lesions using a new double-channel endoscope (the "R-scope"). Endoscopy. 2006 Oct;38(10):1016-23. doi: 10.1055/s-2006-944830.
PMID: 17058167
citation: Adler A, Wegscheider K, Lieberman D, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Mross M, Scheel M, Schroder A, Gerber K, Stange G, Roll S, Gauger U, Wiedenmann B, Altenhofen L, Rosch T. Factors determining the quality of screening colonoscopy: a prospective study on adenoma detection rates, from 12,134 examinations (Berlin colonoscopy project 3, BECOP-3). Gut. 2013 Feb;62(2):236-41. doi: 10.1136/gutjnl-2011-300167. Epub 2012 Mar 22.
PMID: 22442161
citation: Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.
PMID: 22056301
citation: Adler A, Aschenbeck J, Yenerim T, Mayr M, Aminalai A, Drossel R, Schroder A, Scheel M, Wiedenmann B, Rosch T. Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: a prospective randomized trial. Gastroenterology. 2009 Feb;136(2):410-6.e1; quiz 715. doi: 10.1053/j.gastro.2008.10.022. Epub 2008 Oct 15.
PMID: 19014944
citation: Adler A, Pohl H, Papanikolaou IS, Abou-Rebyeh H, Schachschal G, Veltzke-Schlieker W, Khalifa AC, Setka E, Koch M, Wiedenmann B, Rosch T. A prospective randomised study on narrow-band imaging versus conventional colonoscopy for adenoma detection: does narrow-band imaging induce a learning effect? Gut. 2008 Jan;57(1):59-64. doi: 10.1136/gut.2007.123539. Epub 2007 Aug 6.
PMID: 17681999
citation: Pohl H, Aschenbeck J, Drossel R, Schroder A, Mayr M, Koch M, Rothe K, Anders M, Voderholzer W, Hoffmann J, Schulz HJ, Liehr RM, Gottschalk U, Wiedenmann B, Rosch T. Endoscopy in Barrett's oesophagus: adherence to standards and neoplasia detection in the community practice versus hospital setting. J Intern Med. 2008 Oct;264(4):370-8. doi: 10.1111/j.1365-2796.2008.01977.x. Epub 2008 May 15.
PMID: 18482289
citation: Meining A, Ott R, Becker I, Hahn S, Muhlen J, Werner M, Hofler H, Classen M, Heldwein W, Rosch T. The Munich Barrett follow up study: suspicion of Barrett's oesophagus based on either endoscopy or histology only--what is the clinical significance? Gut. 2004 Oct;53(10):1402-7. doi: 10.1136/gut.2003.036822.
PMID: 15361485
citation: Heldwein W, Dollhopf M, Rosch T, Meining A, Schmidtsdorff G, Hasford J, Hermanek P, Burlefinger R, Birkner B, Schmitt W; Munich Gastroenterology Group. The Munich Polypectomy Study (MUPS): prospective analysis of complications and risk factors in 4000 colonic snare polypectomies. Endoscopy. 2005 Nov;37(11):1116-22. doi: 10.1055/s-2005-870512.
PMID: 16281142
responsible party type: Principal Investigator
investigator affiliation: Universitätsklinikum Hamburg-Eppendorf
investigator full name: Prof. Dr. Thomas Rösch
investigator title: Clinical Director, Department of Interdisciplinary Endoscopy
mesh term: Adenoma
mesh term: Neoplasms
mesh term: Carcinoma in Situ
mesh term: Adenomatous Polyps
sharing ipd: No