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临床试验/NCT02140034
NCT02140034Unknown不适用

Extensive Peritoneal Lavage After Curative Gastrectomy for Gastric Cancer: A Randomised Controlled Trial (EPL Study)

National University Hospital, Singapore2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
2
主要终点
Overall Survival

研究概览

简要总结

This study is carried out to determine the merit and reliability of extensive intraoperative peritoneal lavage as a preventive strategy

Hypothesis: EPL significantly improve the overall survival of patients by reducing the risk of peritoneal recurrence

详细描述

Gastric cancer is the second most common cause of cancer death worldwide. Surgery is the mainstay treatment for cure. Peritoneum is a common site of recurrence and the prognosis in patients with peritoneal recurrence is dismal. Hence, prevention is essential to patient's outcomes. In patients with serosal invasion, about half experience peritoneal recurrence within first 2 years after surgery, even after curative surgery. Peritoneal metastasis is caused by the implantation of free cancer cells in the peritoneal cavity exfoliated from the primary tumor before or during curative surgery. It is well known that cancer cells spillage could occur during surgery due to manipulation or even after lymph node dissection. If we can remove these free exfoliated cancer cells on the peritoneal lining, we may reduce the risk of tumor recurrence.

Recently, a study has demonstrated a dramatic reduction of peritoneal recurrence with extensive peritoneal lavage (EPL) in patients who underwent curative resection of gastric cancer. EPL was performed after the curative operation . The peritoneal cavity was washed with normal saline which is then followed by the complete aspiration of the fluid. This procedure was done 10 times using 1 liter of normal saline. The method was based on the 'limiting dilution theory' in which the method can dilute the number of free cancer cells to minimal hence reduce the risk of tumor implantation. In this study, among patients with microscopic peritoneal metastasis, peritoneal recurrence developed in 40% of patients with EPL and surgery, compared to 89.7% in patients with surgery alone. EPL carries minimal risk to patients. It is simple and inexpensive, and it is not time consuming. Hence, it may be an effective strategy for treatment of 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
Prevention
盲法
Single (Participant)

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have T3 (subserosal) or T4 (serosal) disease based on CT scan and intra-operative inspection with any N staging and M0 gastric cancer.
  • Patients planned for open or laparoscopic gastrectomy.
  • Patients undergoing gastrectomy with curative intent.
  • Lower age limit of research subjects 21 years old and upper age limit of 80 years old.
  • Ability to provide informed consent

排除标准

  • Patients who undergo a palliative gastrectomy.
  • Patients who undergo a gastrectomy as emergency.
  • Vulnerable persons under age of
  • Patients receiving neoadjuvant therapy.
  • Patients presented with life-threatening bleeding from tumour
  • ASA score of 4 & 5
  • Patients with another primary cancer within last 5 years
  • Patients with gross peritoneal and liver metastasis at surgery.

结局指标

主要结局

Overall Survival

时间窗: 3 years

次要结局

  • Peritoneal Recurrence Rate(3 years)
  • Disease Free Survival(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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