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临床试验/NCT03646110
NCT03646110Unknown不适用

The Comparison of Single and Multi-incision Minimally Invasive Esophagectomy for Treating Esophageal Cancer

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年8月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Overall survival rate

研究概览

简要总结

Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE).The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.

详细描述

Surgery remains the main stay of treating esophageal cancer. However, esophagectomy is a complex and technical demanding surgical procedure harboring substantial morbidity and mortality. Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. The standardized procedure including lymph node dissection, esophageal mobilization and reconstruction can be effectively performed under minimized wound incision whereas rendering the patients a possibility of faster postoperative recovery and reduced risk of perioperative postoperative pulmonary complication. The procedure of MIE including the thoracoscopic and laparoscopic phases which are usually performed multiple incisional wounds. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE). The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.

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
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of esophageal cancer
  • Age between 35 to 75 years old
  • Resectable tumor as evaluation by preoperative imaging studies.

排除标准

  • Previous surgery in the chest or abdomen.
  • Receiving definitive chemoradiation (5500 cGy or more).
  • Tumor invasion to the trachea, spine or aorta.
  • Liver cirrhosis with esophageal varices or liver cirrhosis refractory to medical treatment, Child C classification.
  • Previous history of cerebral vascular attack.

结局指标

主要结局

Overall survival rate

时间窗: 60 months

Overall survival rate of the participants after surgery

次要结局

  • Ratio of ambulation(post-operative day 2 (POD2))
  • Pain score as assessed by the face rating scale(1,7,14,28 days)
  • Postoperative force vital capacity(1 and 3 months)
  • Post operative forced expiratory volume in one second(1 and 3 months)
  • Postoperative pulmonary complication(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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