A Clinical Prospective Study to Validate a Risk Scoring Model for the Hepatic Metastases From Gastric Cancer After Curative Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- hepatic metastasis
研究概览
简要总结
A previous study of investigators established a risk scoring model for occurrence of postoperative hepatic metastases in patients who underwent curative gastrectomy directly without neoadjuvant therapy. In order to further validate the clinical applicability of abovementioned model, investigators designed this prospective study, which also included patients who received neoadjuvant therapy before surgery, with the aim of exploring the applicability of the risk scoring model to this group of patients.
详细描述
The study was a single-centre, prospective study. Prospectively collected data were used to analyze the consistency between the actual outcomes of patients with or without hepatic metastases after curative gastrectomy and the predicted outcomes of the risk scoring model, in order to assess the clinical applicability of the model. In addition, analyses were performed to compare the differences in the risk of hepatic metastasis and the time interval of occurrence between patients who did not receive neoadjuvant therapy and those who received neoadjuvant therapy, as well as between patients with different outcomes after receiving neoadjuvant therapy (TRG 0-1 vs. TRG 2-3 in postoperative pathology).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received curative gastrectomy (D2 lymph node dissection);
- •Gastric cancer without distant organ metastasis, distant lymph node metastasis and peritoneal implantation (M0) confirmed by postoperative pathology;
- •No hepatic tumors and other occupying diseases, no chronic diseases such as cirrhosis and hepatitis, no hepatic schistosomiasis, no hepatic echinococcosis, no hepatic tuberculosis, and no severe fatty liver disease before the curative surgery;
- •No history of intraperitoneal chemotherapy;
- •No other serious concomitant diseases with satisfactory organ function;
- •No history of other malignant tumors;
- •Comply with the protocol during the whole study period;
- •Sign informed consent and permission of withdraw in the whole study period;
- •Estimation the overall survival after surgery no less than 12 months;
- •Consent to analysis of clinicopathological data and prognostic follow up;
- •Karnofsky Performance Scores (KPS) more than 60.
排除标准
- •Special histological types of gastric cancer (neuroendocrine, squamous, squamous cell, hepatoid adenocarcinoma or others);
- •Gastro-esophageal junction cancer;
- •Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months;
- •Immunosuppressive therapists for organ transplantation;
- •Seriously uncontrolled recurrent infection;
- •History of other malignancies;
- •No abilities of self-knowledge or mental disorders;
- •Combination of other serious diseases;
- •Concurrent participation in other clinical trials.
结局指标
主要结局
hepatic metastasis
时间窗: 2 years after curative surgery
Postoperative telephone follow-up was performed in patients with gastric cancer undergoing curative gastrectomy to determine the occurrence of hepatic metastasis.
次要结局
- interval between the surgery and hepatic metastasis(2 years after curative surgery)