The STOMACH Trial: Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- Extent of lymph node dissection
研究概览
简要总结
Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. All while maintaining similar results with regard to tumour resection margin and oncological survival. In gastric cancer the role of laparoscopic surgery remains unclear.
Current recommended treatment for gastric cancer consists of radical resection of the stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, It is imperative that a new surgical technique should be non-inferior with regard to radicality and lymph node yield.
Preliminary studies show promising results for laparoscopic gastrectomy, but the number of studies is small and due to lower incidence of gastric cancer in the West they are often underpowered. A prospective randomised clinical trial is indicated in order to establish the optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy.
Results of the STOMACH trial will further aid in determining the optimal surgical technique in patients with gastric cancer.
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, Investigator)
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
- •Age equal to or above 18 years
- •Primary adenocarcinoma of stomach, indication for total gastrectomy with curative intent.
- •Neoadjuvant therapy (epirubicin, cisplatin, capecitabine)
- •Surgical resectable (T1-3, N0-1, M0)
- •Informed consent
排除标准
- •Previous or coexisting cancer
- •Previous surgery of the stomach
- •ASA classification (American Society of Anaesthesiologists) score 4 or higher
研究组 & 干预措施
Minimally-invasive Gastrectomy
Patients allocated to the 'Minimally-invasive Gastrectomy' group will undergo minimally-invasive/laparoscopic total gastrectomy. If, during surgery, laparoscopic resection does not seem feasible, the procedure may be converted to an open one.
干预措施: Minimally-invasive gastrectomy (Procedure)
Open Gastrectomy
Patients allocated to the 'Open Gastrectomy' group will receive total resection of the stomach via laparotomy. This group is considered the control group
干预措施: Open Gastrectomy (Procedure)
结局指标
主要结局
Extent of lymph node dissection
时间窗: two weeks
The extent of lymph node dissection in treatment of gastric cancer is considered a prognostic marker for postoperative survival and disease-free survival. Before implementation of a new surgical technique, it is imperative that this technique is non-inferior with regard to the extent of lymph node dissection. Measures will include the number of resected lymph nodes and the number of resected lymph node stations.
次要结局
- Duration of hospital admission(during admission, average 2 weeks)
- Duration of Surgery(Peri-operatively, 1 day)
- Cost-effectiveness(from surgery to one year follow-up)
- Duration of Intensive Care admission(During submission, average 2 days)
- Disease-free survival(up to 5 years postoperatively)
- Postoperative complications(Postoperatively with follow-up to one year)
- Quality of Life(1 and 5 days postoperatively, 3 months, 6 months and 12 months)
- Peri-operative blood loss(during surgery, 1 day)
研究者
J. Straatman
MD
Amsterdam UMC, location VUmc