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临床试验/NCT02330913
NCT02330913已完成不适用

Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy: π-shape Esophagojejunostomy, Three-in-one Technique

Keimyung University Dongsan Medical Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Anastomosis related complication rate

研究概览

简要总结

Laparoscopic gastrectomy became a good option for early gastric cancer. Surgical trend is gradually changed to totally laparoscopic gastrectomy from laparoscopy-assisted gastrectomy requiring mini-laparotomy. Various types of intracorporeal anastomosis have been introduced for esophagojejunostomy during total gastrectomy. We invented a novel anastomosis method using linear stapler for total gastrectomy. Three procedures (Jejunal resection, esophageal resection and closure of common entry hole after anastomosis) was performed with only one stapler. Therefore, the novel method is simple and fast. Also, this new technique is better economically than previously introduced anastomosis using linear stapler because lesser number of stapler is required. We want to demonstrate the feasibility of novel intracorporeal anastomosis method during laparoscopic total gastrectomy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Histologically confirmed adenocarcinoma in stomach
  • Males or Females, aged≥20 years and ≤80 years
  • Without serosa invasion, extraperigastric lymph node metastasis and other organ metastasis stage in preoperative evaluation, (cT1-3N0-1M0)
  • Beyond the indication of ESD
  • Tumor location in high body of stomach or requiring total gastrectomy
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry
  • American Society of Anesthesiolosists (ASA) score of 1 to 3
  • The patient has given their written informed consent to participate in the study

排除标准

  • Simultaneous malignancy in other organ
  • Experience of previous laparotomy
  • Experience of gastric resection including wedge resection
  • Vulnerable subject

结局指标

主要结局

Anastomosis related complication rate

时间窗: During 30 days after operation

Anastomotic leakage, intraluminal bleeding, or stenosis were considered as anastomosis related complication

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seung Wan Ryu

Director of Gastrointesinal surgery, associate professor

Keimyung University Dongsan Medical Center

研究点 (2)

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