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Completed

NCT Number: NCT03035071

Morbidity in Open Versus Minimally Invasive Esophagectomy

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.

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

minimally invasive esophagectomy

Procedure

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.

open esophagectomy

Procedure

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 outcomes

  1. morbidity

    Time frame: 30 days

    anastomotic leakage, gastric conduit necrosis and/or pneumonia

  2. mortality

    Time frame: 30 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Austrian Society Of Surgical Oncology

Other

Registry information

Official study title

Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy

Acronym: MIOMIE

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
Jan 27, 2017
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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