Morbidity in Open Versus Minimally Invasive Esophagectomy

Not Applicable

Completed

• Conditions: Esophageal Cancer

• Registration Number: NCT03035071
• Lead Sponsor: Austrian Society Of Surgical Oncology

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.

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)

Study Timeline

• Study Start: 2010-05-01
• Primary Completion: 2014-11-19
• Study Completion: 2016-04-18
• Status Verified: 2017-01
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-26
• Last Update Submitted: 2017-01-26
• Study First Posted: 2017-01-27
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mortality	30 days
morbidity	30 days	anastomotic leakage, gastric conduit necrosis and/or pneumonia

Secondary Outcome Measures

Name	Time	Method
relapse free survival	5 years	long term relapse free survival
hospital stay	90 days	length of stay at the hospital
ICU stay	90 days	length of stay at the intensive care unit (ICU)
overall survival	5 years	long term overall survival