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临床试验/NCT04206696
NCT04206696已完成不适用

Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure

The Second Hospital of Shandong University0 个研究点目标入组 384 人开始时间: 2010年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
384
主要终点
bleeding volume

研究概览

简要总结

Minimally invasive oesophagectomy is a technically demanding procedure; thus, the learning curve of this procedure should be explored. Then the mature minimally invasive oesophagectomy procedure should be contrasted with the open procedure.

详细描述

Between July 2010 and August 2016, 214 patients underwent MIE (thoracoscopic-laparoscopic oesophagectomy) for oesophageal squamous cell carcinoma in the Thoracic Department, The Second Hospital of Shandong University. Eight of these 214 patients were converted to thoracotomy or laparotomy, one patient was unable to tolerate single-lung ventilation due to a history of left upper lobectomy, and the other seven patients were due to bleeding controlling. Among the 214 patients enrolled, there were 182 males and 32 females in the MIE group. A total of 170 patients underwent oesophagectomy by open thoracotomy from August 2014 to August 2016, and these patients were defined as the open group. The data from the patients in the open group were compared with those of the patients who underwent thoracoscopic-laparoscopic oesophagectomy during the same clinical period. All patients were preoperatively diagnosed with oesophageal cancer by endoscopy and biopsy, with routine thoracic and abdominal enhanced computed tomography (CT) scans and endoscopic ultrasonography to evaluate the clinical TNM stage. The operations were performed by a single surgical team. This study was approved by the ethics committee and Medical Administration Division of the Second Hospital of Shandong University. Written informed consent was obtained from each of the enrolled patients. All methods performed in the investigator's study were conducted in accordance with the relevant guidelines and regulations.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • oesophageal cancer diagnosed by endoscopy and biopsy good cardiopulmonary function to tolerate surgery

排除标准

  • poor cardiopulmonary function distant metastasis T4 with little possibility of radical resection

结局指标

主要结局

bleeding volume

时间窗: Between July 2010 and August 2016

bleeding volume in milliliter

complications

时间窗: Between July 2010 and August 2016

complications in percentage

mortality

时间窗: Between July 2010 and August 2016

mortality in percentage

lymphadenectomy

时间窗: Between July 2010 and August 2016

lymphadenectomy in number

operation time

时间窗: Between July 2010 and August 2016

operation time in minutes

次要结局

  • 2-year disease-free survival(Between August 2016 and August 2018)
  • 2-year overall survival rate(Between August 2016 and August 2018)

研究者

申办方类型
Other
责任方
Sponsor

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