Morbidity in Open Versus Minimally Invasive Esophagectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Procedure: minimally invasive esophagectomy
* Procedure: open esophagectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: minimally invasive esophagectomy<br>minimally invasive (laparoscopic) gastric mobilisation and gastric tube formation. | Procedure: minimally invasive esophagectomy<br>* 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.<br>|
| Active Comparator: open esophagectomy<br>open gastric mobilization and gastric tube formation | Procedure: open esophagectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity | anastomotic leakage, gastric conduit necrosis and/or pneumonia | 30 days | 
| mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay | length of stay at the intensive care unit (ICU) | 90 days | 
| hospital stay | length of stay at the hospital | 90 days | 
| overall survival | long term overall survival | 5 years | 
| relapse free survival | long term relapse free survival | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimal-invasive esophagectomy, Esophageal resection, Hybrid esophagectomy