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临床试验/NCT04327050
NCT04327050Unknown不适用

Prospective Clinical Trial of Magnetic Anchoring Guided Endoscopic Submucosal Dissection for Early Gastric Caner

First Affiliated Hospital Xi'an Jiaotong University0 个研究点目标入组 30 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
success rate

研究概览

简要总结

This study uses magnetic anchored guidance system to treat early gastric cancer by endoscopic mucosal dissection to test the advantages of magnetically anchored guidance system for surgical field exposure during endoscopic mucosal dissection.

详细描述

Gastric cancer is the second most common malignant tumor in China, with the highest mortality rate among all types of malignant tumors. Surgical resection is still the most effective treatment for gastric cancer. Minimally invasive surgery breaks the traditional surgical concept that the laparotomy must be performed by laparotomy. It can complete the operation that required a large incision with minimal incision trauma, and has the advantages of less trauma, faster recovery and fewer complications. At present, the application of gastroscopy and laparoscopy for early gastric cancer has reached consensus at home and abroad. Endoscopic mucosal resection of early gastric cancer is suitable for patients with intramucosal cancer and no lymph node metastasis. However, the unclear exposure of the surgical field during the operation causes difficulty in operation or conversion to open surgery is a difficult problem facing this technique. The project designed a magnetic pulling unit that can be connected through an endoscope, including external abdominal magnets, internal abdominal magnets, connecting hooks, and micro surgical tweezers. Using magnetic anchoring technology, the magnetic pulling unit is anchored to the abdominal wall, and micro surgical tweezers are used. The tumor tissue is pulled indirectly, so that the mucosa is lifted up, which is beneficial to the peeling of the submucosa. This method increases the operating space of the main hand of the endoscope, and at the same time, the magnetic clamp is used to connect the clamps so that they can move in all directions, so as to achieve the desired traction of the tumor tissue site, fully expose the surgical field, and facilitate surgical anatomy.

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

盲法说明

No masking required

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are diagnosed as of gastric cancer by a preliminary endoscopy or biopsy sampling

排除标准

  • Patients with a cardiac pacemaker or severe cardiac and/or pulmonary diseases
  • Patients without informed consent
  • Patients with other malignant tumors

结局指标

主要结局

success rate

时间窗: through study completion, an average of 1 year

The rate of the complete resection of gastric lesion by magnetic anchored guided endoscopic submucosal dissection

次要结局

  • complications(measured at the time of the end of each ESD; up to 1 hour)

研究者

申办方类型
Other
责任方
Sponsor

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