Laparoscopic Versus Open Gastrectomy for Gastric Cancer, a Multicenter Prospectively Randomized Controlled Trial (LOGICA-trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 210
- 试验地点
- 10
- 主要终点
- Post-operative hospital stay
研究概览
简要总结
This is the first randomized controlled trial comparing laparoscopic and open gastrectomy for resectable gastric cancer in a Western population. The hypothesis is that laparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better post-operative quality of life, with similar mortality and oncologic outcomes, compared to open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take three and five years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.
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
- None
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
- •Histologically proven adenocarcinoma of the stomach
- •Surgically resectable (cT1-4a, N0-3b, M0) tumor
- •Age ≥ 18 years
- •European Clinical Oncology Group (ECOG) performance status 0, 1 or
- •Written informed consent
排除标准
- •Siewert type I esophagogastric junction tumor
- •Non-elective surgery
- •Previous gastric resection or recurrent gastric cancer
- •Pregnancy
研究组 & 干预措施
Open Gastrectomy
Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
干预措施: Open Gastrectomy (Procedure)
Laparoscopic Gastrectomy
Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy.
干预措施: Laparoscopic Gastrectomy (Procedure)
结局指标
主要结局
Post-operative hospital stay
时间窗: During admission, an expected average of 2 weeks
The primary outcome of this study is the post-operative hospital stay (days), since this is considered a strong end point as it reflects the impact of the different surgical procedures.
次要结局
- Mortality(30 days post-operative)
- Post-operative morbidity(Up to 5 years post-operative)
- Cost-effectiveness(Up to 5 years post-operative)
- Quality of Life(Up to 5 years post-operative)
- Readmissions(Up to 5 years post-operative)
- Oncologic outcomes (R0-resection rate and lymph node yield)(Pathology report 1-2 weeks after surgery)