Prospective, Observational, Multicenter Study on Minimally Invasive Gastrectomy for Gastric Cancer: Robotic, Laparoscopic and Open Surgery Compared on Operative and Follow-up Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Rate of patients with intraoperative adverse events
研究概览
简要总结
The overall purpose is to develop and maintain a multi-institutional database comprising of information regarding surgical, clinical and oncological features of patients that will be treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.
The main objective is to compare the three surgical arms on surgical and clinical outcomes, as well as on the oncological follow-up.
详细描述
A review of the scientific literature, which was recently published by the IMIGASTRIC study group, aimed to perform a more complete analysis of the current situation regarding performing minimally invasive surgery for gastric cancer. Significant limitations were found in the analyzed studies, including:
- Small samples of patients, mostly low-quality comparative studies
- Selection bias in the comparison groups (e.g. stage, extent of lymphadenectomy)
- Absence of subgroup analysis in significant research fields
- Lack of information on the surgical techniques adopted
A large prospective multicenter registry could thus be the optimal way to clarify the role of minimally invasive surgery for gastric cancer and permit the evaluation of its short and long-term effects. A working basis for analyzing outcomes of interest and obtaining directions for guidelines and future study developments can also be created. The following would be the main advantages of a large prospective multicenter registry:
- Achieving a large sample of patients
- Collecting multiple variables, allowing for the making of a comprehensive statistical report
- Standardizing the methodology to be adopted, thus increasing accuracy
- Bringing together the experiences of both East and West to discover shared points A prospective registry can become a powerful tool that can guide research in this field to new developments and pave the way for other investigational opportunities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •Histologically proven gastric cancer
- •Preoperative staging work-up performed by upper endoscopy and/or endoscopic ultrasound, and CT scan and in accordance to international guidelines
- •Early Gastric Cancer
- •Advanced Gastric Cancer
- •Patients treated with curative intent in accordance to international guidelines
排除标准
- •Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, Krukenberg tumors, involvement of other organs
- •Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score > 4
- •History of previous abdominal surgery for gastric cancer
- •Synchronous malignancy in other organs
- •Palliative surgery
结局指标
主要结局
Rate of patients with intraoperative adverse events
时间窗: During surgery
events other than the normal course of the surgery
Mean of retrieved lymph nodes
时间窗: Within 30 days after surgery
Count of retrieved lymph nodes at the histopathological examination of the surgical specimen
Rate of patients alive
时间窗: 5 year after surgery
subjects alive at the planned endpoint
次要结局
- Mean post-operative hospital stay(from the day after surgery to patient discharge, assessed up to 90 days)
- Rate of complications after discharge(5 year after surgery)
研究者
Amilcare Parisi
Principal Investigator
International Study Group on Minimally Invasive Surgery for Gastric Cancer