Non-inferiority Randomized Clinical Trial Comparing Omenectomy and Omental Preservation in Resectable Gastric Cancer
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
- 否
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
Sandra Montmany-Vioque
MD, PhD
Corporacion Parc Tauli
