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临床试验/NCT05747482
NCT05747482尚未招募不适用

Non-inferiority Randomized Clinical Trial Comparing Omenectomy and Omental Preservation in Resectable Gastric Cancer

Corporacion Parc Tauli0 个研究点目标入组 569 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
569
主要终点
disease free interval

研究概览

简要总结

European clinical guidelines do not establish a clear recommendation neither for nor against omentectomy of this segment, the American clinical guidelines recommend omentectomy in view of its potential long-term oncological benefit, and Japanese clinical guidelines only recommend 2nd segment omentectomy in locally advanced gastric cancers (stage T3-T4) recommending omental preservation in early gastric cancers (stage T1-T2).

Faced with this lack of consensus, we propose a randomized, prospective and multicentric study in patients with resectable gastric cancer in stage T3-4 N+/- M0. Patients will be randomized into two groups, one where omentectomy of the 2nd omental portion will be performed and another where omental preservation will be performed.

The aim of our study is to analyze the disease-free interval and survival between both groups, also comparing postoperative complications and mortality.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Older than 18 years old
  • Resectable gastric cancer
  • Gastric cancer T3-4 N+/- M0

排除标准

  • Non surgical patients for medical status
  • Non resectable gastric cancer during surgery
  • Endoscopic resectable gastric cancer

结局指标

主要结局

disease free interval

时间窗: 5 years

time between surgery and recurrence. Units of measure: months

次要结局

  • postoperatory mortality(30 days after surgery)
  • survival at 5 years(5 years)
  • complications - CCI(30 days after surgery)
  • global survival(5 years)

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Montmany-Vioque

MD, PhD

Corporacion Parc Tauli

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