NCT00937456已完成不适用
Open vs Laparoscopically-assisted Esophagectomy for Cancer: A Multicentric Phase III Prospective Randomized Controlled Trial
University Hospital, Lille22 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2009年10月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 22
- 主要终点
- To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm.
研究概览
简要总结
To compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in Ivor-Lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.
详细描述
Open Versus Laparoscopically-assisted Esophagectomy for Cancer
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Squamous cell or adenocarcinoma of the thoracic esophagus T1, T2, T3, N0-N1, M0, before any treatment
- •Middle or lower third esophageal carcinoma, junctional tumor Siewert type I
- •Patients who underwent or not neoadjuvant chemotherapy or chemoradiation
- •Tumor deemed to be resectable in a curative intent at the preoperative setting
- •Age less than 75 years old, OMS status 0, 1 or 2
- •Patient who can undergo one or the other surgical modality
- •Written informed consent form
- •Possible follow-up
排除标准
- •General criteria: PO2 ≤ 60 mmHg; PCO2 > 45 mmHg; FEV ≤ 1000 ml/sec
- •Hepatic cirrhosis
- •Recent myocardial infarction (in the previous 6 months) or progressive coronary disease
- •Distal arteritis (Leriche-Fontaine stage II upwards)
- •Concomitant cancer, other than subcarinal esophageal cancer
- •Disease-related factors
- •Invasion of subclavicular lymph nodes in a clinical examination or on biospy
- •Lymph nodes near the origin of the celiac artery with a diameter ≥ 1 cm on CT or that appear to be suspect on endoscopic ultrasound (to differentiate them from the paracardial or left gastric lymph nodes, which does not constitute an exclusion criterion)
- •Recurrent nerve palsy
- •Evidence of extension to the tracheobronchial tree
- •Signs of mediastinal invasion (vertebral contact, aortic contact ≥ 90°, or invasion of nonresectable neighboring organs such as the aorta, trachea, main bronchi, etc.)
- •Distant metastasis
- •Laparoscopy-related factors
- •Patient presenting a general contraindication to laparoscopy
- •A history of median or subcostal laparotomy
研究组 & 干预措施
Laparoscopically-assisted esophagectomy
Experimental
Laparoscopically-assisted esophagectomy: standard abdominal procedure of gastric mobilisation but through laparoscopic route. Right thoracotomy as usual.
干预措施: Laparoscopically-assisted esophagectomy (Procedure)
Open esophagectomy
Active Comparator
Conventional open esophagectomy: Esophagectomy with extended 2-field lymphadenectomy through laparotomy and right thoracotomy (Ivor-Lewis standard procedure)
干预措施: Laparoscopically-assisted esophagectomy (Procedure)
结局指标
主要结局
To decrease postoperative major 30-days morbidity from 45% in the open arm to 25% in the laparoscopically-assisted arm.
时间窗: 30 days
次要结局
- quality of life(2 years)
- disease free survival(2 years)
- economical interest of the surgical technique apprehended through a hospital point of view(6 months)
- overall morbidity(30 days)
- overall survival(2 years)
研究者
研究点 (22)
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