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临床试验/NCT03035071
NCT03035071已完成不适用

Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy

Austrian Society Of Surgical Oncology0 个研究点目标入组 26 人开始时间: 2010年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
主要终点
mortality

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

mortality

时间窗: 30 days

morbidity

时间窗: 30 days

anastomotic leakage, gastric conduit necrosis and/or pneumonia

次要结局

  • relapse free survival(5 years)
  • ICU stay(90 days)
  • overall survival(5 years)
  • hospital stay(90 days)

研究者

发起方
Austrian Society Of Surgical Oncology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthias Paireder

MD

Medical University of Vienna

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