Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- R0 resection rate
研究概览
简要总结
The real world based multi-cohorts study aims to evaluate the safety and effectiveness of function preserving gastrectomy including pylorus-preserving distal gastrectomy, proximal gastrectomy and wedge gastrectomy for T1 and T2 gastric cancer patients.
详细描述
Gastric cancer patients with clinical stage T1/2 will be screened for the study. For the patients enrolled, a multidisciplinary discussion will be performed to evaluate the proper gastrectomy for the patients and functional preserving gastrectomy will be considered for the indicated patients. For patients not proper for functional preserving gastrectomy, standard gastrectomies will be suggested. After surgery, a close follow up will be performed. During the study, a thorough data collection will be performed to evaluate the safety and effectiveness of functional preserving gastrectomy and recovery and postoperative function of remnant stomach.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Karnofsky performance over 70%
- •Histologically proven gastric or gastroesophageal joint adenocarcinoma with clinical stage T1-2N0-3M0
- •No severe comorbidity with estimated survival less than 5 years
排除标准
- •pregnancy
- •Signs of distant metastases
- •received chemotherapy, radiotherapy, immune therapy
- •received gastrectomy
- •other malignant tumors within 5 years except for cured skin cancer and cervical caner in situ.
- •uncontrolled epilepsy, central nervus system disease or mental disease that affect the compliance of treatment and follow-up
- •severe heart disease
- •organ transplantation that needs immunosuppressor
- •emergency surgery due to hemorrhage, perforation and ileus of gastric cancer
结局指标
主要结局
R0 resection rate
时间窗: 30 days after surgery
Pathologic R0 resection rate with negative proximal and distal margin based on the postoperative pathologic result.
次要结局
- Distribution of metastatic lymph node(30 days after surgery)
- Quality of life after surgery(3 years after surgery)
- postoperative morbidity(30 days after surgery)
- disease free survival(3 years after surgery)
- overall survival(3 years after surgery)
- Extent of lymphadenectomy of different gastrectomy(30 days after surgery)
- postoperative mortality(30 days after surgery)
- remnant stomach function(3 years after surgery)
研究者
Ziyu Li, MD
Principal Investigator, Clinical Professor
Peking University