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临床试验/NCT02216110
NCT02216110已完成不适用

Long-term Outcomes of Endoscopic Submucosal Dissection Versus Gastrectomy for Early Gastric Cancer

Soonchunhyang University Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2003年5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
500
试验地点
1
主要终点
Patient's death

研究概览

简要总结

Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic submucosal dissection (ESD) has been accepted as standard treatment in selected patients with negligible risk of lymph node metastasis. However, there are limited data regarding the long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.

详细描述

The prevalence of gastric cancer is high in Asia, especially in Korea and Japan. In Korea, the detection rate of EGC has increased with mass screening for the prevention of gastric cancer-related death. EGC is defined as mucosal or submucosal cancer, regardless of regional lymph node metastasis. The presence of lymph node metastasis has been reported to range from 2% to 18%. For this reason, radical gastrectomy with lymph node dissection was considered as the only curative treatment. In EGC patients, surgical outcome demonstrated excellent 5-year survival rate above 90%.

In 2000, EGC subgroups with negligible risk of lymph node metastasis were proposed on the basis of large scale retrospective data. Thereafter, the result was adopted as expanded criteria for endoscopic resection of EGC. ESD is useful technique to dissect the tumor along the submucosal layer using various endoscopic knives. Compared to endoscopic mucosal resection (EMR), ESD achieved a higher complete resection rate and a lower local tumor recurrence rate.

Although curative resection is pathologically achieved by ESD, post-resection surveillance is needed to confirm the presence of nodal metastasis. Recently, several studies reported that 5-year overall and disease-specific survival rate were highly favorable in EGC patients who underwent curative ESD. However, there is no comparative study about long-term outcomes after ESD and gastrectomy. Therefore, this protocol aims to evaluate overall survival rate, tumor recurrence, development of metachronous cancers between ESD and surgery groups.

研究设计

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

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

  • differentiated type mucosal cancer without ulceration, regardless of tumor size
  • differentiated type mucosal cancer with ulceration ≤ 3 cm in diameter
  • superficial (SM1 < 500 μm) submucosal cancer ≤ 3 cm in diameter
  • undifferentiated type mucosal cancer without ulceration ≤ 2 cm in diameter

排除标准

  • early gastric cancer in a remnant stomach
  • gastrectomy due to metachronous lesions during follow-up period
  • post-ESD additional surgery due to high risk of lymph node metastasis or the possibility of residual tumor

结局指标

主要结局

Patient's death

时间窗: up to 5 years

次要结局

  • Tumor recurrence(up to 5 years)
  • Development of metachronous cancers(up to 5 years)

研究者

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

Jun-Hyung Cho

Assistant Professor

Soonchunhyang University Hospital

研究点 (1)

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