<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/NCT03035071</url>
  </required_header>
  <id_info>
    <org_study_id>AUT-MIOMIE-RCT</org_study_id>
    <nct_id>NCT03035071</nct_id>
  </id_info>
  <brief_title>Morbidity in Open Versus Minimally Invasive Esophagectomy</brief_title>
  <acronym>MIOMIE</acronym>
  <official_title>Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Austrian Society Of Surgical Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Austrian Society Of Surgical Oncology</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MIOMIE trial is a prospective randomized controlled study comparing open and laparoscopic&#xD;
      gastric tube formation in Ivor Lewis esophagectomy. Aim of this trial was to compare the&#xD;
      minimally invasive approach with the standard open procedure regarding morbidity and&#xD;
      mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Esophageal resection is still associated with considerable morbidity and mortality.&#xD;
      Standardized preoperative efforts could increase the outcome of these patients. While early&#xD;
      reports of medical pioneers focused particularly on safety and feasibility, more recent&#xD;
      studies showed that implementation of minimally invasive esophagectomy (MIE) was widely&#xD;
      accepted. Since first reports of MIE, different techniques and adjustments have been&#xD;
      discussed. A recent publication of a large prospective trial in Phase II showed the safety of&#xD;
      a total minimally invasive approach (video assisted thoracoscopic surgery (VATS) and&#xD;
      laparoscopy). Surgical technique however is still a subject of debate and the level of&#xD;
      evidence remains still low. Proving feasibility does not warrant a paradigm shift, as&#xD;
      experience is an important factor for safety and patient benefit.&#xD;
&#xD;
      The aim of this study was to evaluate morbidity and mortality of open esophagectomy (OE)&#xD;
      versus hybrid-MIE in a randomized controlled setting.&#xD;
&#xD;
      Prior to surgery patients will be randomized either the minimally invasive surgery group&#xD;
      (laparoscopic gastric tube formation and thoracotomy) or the the open surgery group (open&#xD;
      gastric tube formation with an open laparotomy approach). Randomizing tool is the&#xD;
      &quot;randomizer&quot; of the medical university of vienna. (link is attached below)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2010</start_date>
  <completion_date type="Actual">April 18, 2016</completion_date>
  <primary_completion_date type="Actual">November 19, 2014</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>morbidity</measure>
    <time_frame>30 days</time_frame>
    <description>anastomotic leakage, gastric conduit necrosis and/or pneumonia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mortality</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>90 days</time_frame>
    <description>length of stay at the intensive care unit (ICU)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital stay</measure>
    <time_frame>90 days</time_frame>
    <description>length of stay at the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>long term overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>relapse free survival</measure>
    <time_frame>5 years</time_frame>
    <description>long term relapse free survival</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>minimally invasive esophagectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>minimally invasive (laparoscopic) gastric mobilisation and gastric tube formation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>open esophagectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>open gastric mobilization and gastric tube formation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>minimally invasive esophagectomy</intervention_name>
    <description>In the MIE group the laparoscopic procedure was performed for gastric tube formation. The patient was placed in supine position with legs apart. The surgeon stands between the legs using a five-trocar technique. Laparoscopy will be followed by an anterolateral thoracotomy in the fourth intercostal space.</description>
    <arm_group_label>minimally invasive esophagectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>open esophagectomy</intervention_name>
    <description>in the open group the gastric mobilization and gastric tube formation will be perfumed with an open surgical approach. Laparotomy will be performed, followed by an anterolateral thoracotomy in the fourth intercostal space.</description>
    <arm_group_label>open esophagectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adenocarcinoma of the esophagus and the esophagogastric junction in (Siewert) type I&#xD;
             and II position&#xD;
&#xD;
          -  esophageal squamous cell cancer&#xD;
&#xD;
          -  patients, who require esophageal resection due to above mentioned diagnosis&#xD;
&#xD;
          -  patients, who gave their informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  individuals who did not meet the inclusion criteria were excluded from the study.&#xD;
&#xD;
          -  patients with tumor localization in the upper third of the esophagus and requiring&#xD;
             cervical resection were excluded.&#xD;
&#xD;
          -  patients, presenting other than AC or ESCC or showed contraindication for laparoscopy&#xD;
             (history of large abdominal surgery or signs of hostile abdomen)&#xD;
&#xD;
          -  patients with a history or presence of any other malignancy, except carcinoma in situ&#xD;
             or basalioma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Medical Research Council Oesophageal Cancer Working Group. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1727-33. doi: 10.1016/S0140-6736(02)08651-8.</citation>
    <PMID>12049861</PMID>
  </reference>
  <reference>
    <citation>Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.</citation>
    <PMID>16822992</PMID>
  </reference>
  <reference>
    <citation>Low DE, Kunz S, Schembre D, Otero H, Malpass T, Hsi A, Song G, Hinke R, Kozarek RA. Esophagectomy--it's not just about mortality anymore: standardized perioperative clinical pathways improve outcomes in patients with esophageal cancer. J Gastrointest Surg. 2007 Nov;11(11):1395-402; discussion 1402. doi: 10.1007/s11605-007-0265-1. Epub 2007 Aug 31.</citation>
    <PMID>17763917</PMID>
  </reference>
  <reference>
    <citation>Schoppmann SF, Prager G, Langer FB, Riegler FM, Kabon B, Fleischmann E, Zacherl J. Open versus minimally invasive esophagectomy: a single-center case controlled study. Surg Endosc. 2010 Dec;24(12):3044-53. doi: 10.1007/s00464-010-1083-1. Epub 2010 May 13.</citation>
    <PMID>20464423</PMID>
  </reference>
  <reference>
    <citation>Schwameis K, Ba-Ssalamah A, Wrba F, Birner P, Prager G, Hejna M, Schmid R, Asari R, Zacherl J, Schoppmann SF. The implementation of minimally-invasive esophagectomy does not impact short-term outcome in a high-volume center. Anticancer Res. 2013 May;33(5):2085-91.</citation>
    <PMID>23645759</PMID>
  </reference>
  <reference>
    <citation>Messager M, Pasquer A, Duhamel A, Caranhac G, Piessen G, Mariette C; FREGAT working groupFRENCH. Laparoscopic Gastric Mobilization Reduces Postoperative Mortality After Esophageal Cancer Surgery: A French Nationwide Study. Ann Surg. 2015 Nov;262(5):817-22; discussion 822-3. doi: 10.1097/SLA.0000000000001470.</citation>
    <PMID>26583671</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Matthias Paireder</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Minimal-invasive esophagectomy</keyword>
  <keyword>Esophageal resection</keyword>
  <keyword>Hybrid esophagectomy</keyword>
  <!-- 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/NCT03035071
org study id: AUT-MIOMIE-RCT
nct id: NCT03035071
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The MIOMIE trial is a prospective randomized controlled study comparing open and laparoscopic
      gastric tube formation in Ivor Lewis esophagectomy. Aim of this trial was to compare the
      minimally invasive approach with the standard open procedure regarding morbidity and
      mortality.
Esophageal resection is still associated with considerable morbidity and mortality.
      Standardized preoperative efforts could increase the outcome of these patients. While early
      reports of medical pioneers focused particularly on safety and feasibility, more recent
      studies showed that implementation of minimally invasive esophagectomy (MIE) was widely
      accepted. Since first reports of MIE, different techniques and adjustments have been
      discussed. A recent publication of a large prospective trial in Phase II showed the safety of
      a total minimally invasive approach (video assisted thoracoscopic surgery (VATS) and
      laparoscopy). Surgical technique however is still a subject of debate and the level of
      evidence remains still low. Proving feasibility does not warrant a paradigm shift, as
      experience is an important factor for safety and patient benefit.

      The aim of this study was to evaluate morbidity and mortality of open esophagectomy (OE)
      versus hybrid-MIE in a randomized controlled setting.

      Prior to surgery patients will be randomized either the minimally invasive surgery group
      (laparoscopic gastric tube formation and thoracotomy) or the the open surgery group (open
      gastric tube formation with an open laparotomy approach). Randomizing tool is the
      "randomizer" of the medical university of vienna. (link is attached below)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: morbidity
time frame: 30 days
description: anastomotic leakage, gastric conduit necrosis and/or pneumonia
measure: mortality
time frame: 30 days
measure: ICU stay
time frame: 90 days
description: length of stay at the intensive care unit (ICU)
measure: hospital stay
time frame: 90 days
description: length of stay at the hospital
measure: overall survival
time frame: 5 years
description: long term overall survival
measure: relapse free survival
time frame: 5 years
description: long term relapse free survival
arm group label: minimally invasive esophagectomy
arm group type: Experimental
description: minimally invasive (laparoscopic) gastric mobilisation and gastric tube formation.
arm group label: open esophagectomy
arm group type: Active Comparator
description: open gastric mobilization and gastric tube formation
intervention type: Procedure
intervention name: minimally invasive esophagectomy
description: In the MIE group the laparoscopic procedure was performed for gastric tube formation. The patient was placed in supine position with legs apart. The surgeon stands between the legs using a five-trocar technique. Laparoscopy will be followed by an anterolateral thoracotomy in the fourth intercostal space.
arm group label: minimally invasive esophagectomy
intervention type: Procedure
intervention name: open esophagectomy
description: in the open group the gastric mobilization and gastric tube formation will be perfumed with an open surgical approach. Laparotomy will be performed, followed by an anterolateral thoracotomy in the fourth intercostal space.
arm group label: open esophagectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
citation: Medical Research Council Oesophageal Cancer Working Group. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1727-33. doi: 10.1016/S0140-6736(02)08651-8.
PMID: 12049861
citation: Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
PMID: 16822992
citation: Low DE, Kunz S, Schembre D, Otero H, Malpass T, Hsi A, Song G, Hinke R, Kozarek RA. Esophagectomy--it's not just about mortality anymore: standardized perioperative clinical pathways improve outcomes in patients with esophageal cancer. J Gastrointest Surg. 2007 Nov;11(11):1395-402; discussion 1402. doi: 10.1007/s11605-007-0265-1. Epub 2007 Aug 31.
PMID: 17763917
citation: Schoppmann SF, Prager G, Langer FB, Riegler FM, Kabon B, Fleischmann E, Zacherl J. Open versus minimally invasive esophagectomy: a single-center case controlled study. Surg Endosc. 2010 Dec;24(12):3044-53. doi: 10.1007/s00464-010-1083-1. Epub 2010 May 13.
PMID: 20464423
citation: Schwameis K, Ba-Ssalamah A, Wrba F, Birner P, Prager G, Hejna M, Schmid R, Asari R, Zacherl J, Schoppmann SF. The implementation of minimally-invasive esophagectomy does not impact short-term outcome in a high-volume center. Anticancer Res. 2013 May;33(5):2085-91.
PMID: 23645759
citation: Messager M, Pasquer A, Duhamel A, Caranhac G, Piessen G, Mariette C; FREGAT working groupFRENCH. Laparoscopic Gastric Mobilization Reduces Postoperative Mortality After Esophageal Cancer Surgery: A French Nationwide Study. Ann Surg. 2015 Nov;262(5):817-22; discussion 822-3. doi: 10.1097/SLA.0000000000001470.
PMID: 26583671
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Matthias Paireder
investigator title: MD