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临床试验/NCT06076265
NCT06076265招募中不适用

Quantitative Detection of CEA mRNA in the Smog and Tissue Exudate Whole Process Collected During Laparoscopic (Robotic) Radical Gastrectomy in Gastric Cancer Patients: Study Protocol for a Single Center Prospective, Single-arm, Longitudinal Pilot Study(SMOG 01Study)

The Affiliated Hospital of Qingdao University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Positive detection rate of CEA

研究概览

简要总结

The purpose of this SMOG 01 study is to observe the possibility of intraperitoneal dissemination of tumor cells throughout the entire laparoscopic (robotic) radical gastrectomy for gastric cancer and explore its related mechanisms and potential clinical significance with peritoneal metastasis.

详细描述

Cytological examination of peritoneal lavage fluid has become an important parameter for pathological staging and prognosis judgment of gastric cancer. However, the vast majority of previous studies have only focused on collecting peritoneal lavage fluid through laparotomy or laparoscopic exploration for cytological and tumor marker monitoring as further tumor staging. Unfortunately, there is no research focusing on whether laparoscopic (or robotic) surgery under the carbon dioxide pneumoperitoneum environment can cause the iatrogenic spread of cancer cells, and there is also a lack of a practical and feasible method to collect smog and tissue exudates generated throughout the entire surgical process for cytological monitoring, to determine whether laparoscopic surgery itself may cause the iatrogenic spread of tumor cell, to uncover the potential mechanisms and propose appropriate preventive measures of peritoneal metastasis. Therefore, the investigators have designed a special device to collect smog and tissue exudates generated during laparoscopic or robotic radical gastrectomy to determine whether there is a possibility of iatrogenic cancer cell dissemination in the abdominal cavity throughout the entire course of laparoscopic or robotic surgery by using RT-PCR to detect CEA mRNA, which can become one of the reasons for gastric cancer peritoneal metastasis.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Gastric adenocarcinoma confirmed by preoperative pathology
  • Endoscopic and CT/MRI enhanced examination confirmed that cT1-4aN0-3M0 has the possibility of resection
  • To undergo radical gastrectomy (laparoscopic or robotic) under general anesthesia+/- epidural anesthesia (carbon dioxide pneumoperitoneum)
  • Willing and able to comply with the research protocol
  • Reach a written consent agreement before registration, and fully realize the right to withdraw from the study at any time without any loss

排除标准

  • Urgent surgery is required due to tumor emergencies (such as bleeding, perforation, and obstruction)
  • Extensive peritoneal metastasis can be seen during intraoperative exploration
  • Other diseases requiring simultaneous surgery
  • Patients with ascites
  • Pregnancy

结局指标

主要结局

Positive detection rate of CEA

时间窗: Supervision of the whole operation: collection of peritoneal lavage fluid at three time points, before the start of the operation, during the operation, and at the end of the operation

Positive detection rate of CEA

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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