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Morbidity in Open Versus Minimally Invasive Esophagectomy (MIOMIE)

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ClinicalTrials.gov Identifier: NCT03035071
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Matthias Paireder, Medical University of Vienna

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: minimally invasive esophagectomy Procedure: open esophagectomy Not Applicable

Detailed Description:

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)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy
Actual Study Start Date : May 1, 2010
Actual Primary Completion Date : November 19, 2014
Actual Study Completion Date : April 18, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: minimally invasive esophagectomy
minimally invasive (laparoscopic) gastric mobilisation and gastric tube formation.
Procedure: minimally invasive esophagectomy
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.

Active Comparator: open esophagectomy
open gastric mobilization and gastric tube formation
Procedure: open esophagectomy
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.




Primary Outcome Measures :
  1. morbidity [ Time Frame: 30 days ]
    anastomotic leakage, gastric conduit necrosis and/or pneumonia

  2. mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. ICU stay [ Time Frame: 90 days ]
    length of stay at the intensive care unit (ICU)

  2. hospital stay [ Time Frame: 90 days ]
    length of stay at the hospital

  3. overall survival [ Time Frame: 5 years ]
    long term overall survival

  4. relapse free survival [ Time Frame: 5 years ]
    long term relapse free survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adenocarcinoma of the esophagus and the esophagogastric junction in (Siewert) type I and II position
  • esophageal squamous cell cancer
  • patients, who require esophageal resection due to above mentioned diagnosis
  • patients, who gave their informed consent

Exclusion Criteria:

  • individuals who did not meet the inclusion criteria were excluded from the study.
  • patients with tumor localization in the upper third of the esophagus and requiring cervical resection were excluded.
  • patients, presenting other than AC or ESCC or showed contraindication for laparoscopy (history of large abdominal surgery or signs of hostile abdomen)
  • patients with a history or presence of any other malignancy, except carcinoma in situ or basalioma

Publications:

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Responsible Party: Matthias Paireder, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03035071     History of Changes
Other Study ID Numbers: AUT-MIOMIE-RCT
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthias Paireder, Medical University of Vienna:
Minimal-invasive esophagectomy
Esophageal resection
Hybrid esophagectomy

Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases