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临床试验/NCT04295473
NCT04295473招募中不适用

Comparison the Short and Long-term Outcome of Patients With Gastric Cancer Who Underwent Reduced Port Laparoscopic Gastrectomy With Patients Underwent Traditional Laparoscopic Gastrectomy

Nanchong Central Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
3-year survival rate

研究概览

简要总结

Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy

详细描述

Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators designed a comparative study, which sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy. The short-term outcome include surgical complications, postoperative morbidity, postoperative nutrition. The long-term outcome mainly include long-term survival.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
  • Eastern Cooperative Oncology Group performance status of 0 or
  • Adequate organ function.

排除标准

  • Patients had distant metastasis.
  • oesophageal invasion of more than 3 cm.
  • Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
  • Previous chemotherapy or radiation therapy for any other malignancies.

结局指标

主要结局

3-year survival rate

时间窗: 3 years

Survival rate for patients with gastrectomy after reduced port laparoscopic gastrectomy

5-year survival rate

时间窗: 5 years

Longterm survival for patients with gastrectomy after reduced port laparoscopic gastrectomy

次要结局

  • Malnutrition rate(6 months)
  • Postoperative morbidity rate(6 months)
  • Quality of life in PGSAS-45 scale(12 months)

研究者

发起方
Nanchong Central Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Yunhong Tian

Professor

Nanchong Central Hospital

研究点 (1)

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