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临床试验/NCT06728878
NCT06728878招募中不适用

Lymph Node Metastasis and Tumor Deposit in the Short Gastric Mesentery Following Total Gastrectomy With D2 Lymphadenectomy Plus Complete Mesogastric Excision for Gastric Cancer: A Prospective Observational Study

Jichao Qin1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Rate of lymph node metastasis and tumor deposit in the short gastric mesentery

研究概览

简要总结

This study aims to explore lymph node metastasis in the short gastric mesentery following total gastrectomy with D2 lymphadenectomy plus complete mesogastric excision, providing evidence-based medicine for standardizing lymph node dissection in gastric cancer.

详细描述

According to the 6th edition of the Japanese Gastric Cancer Treatment Guidelines; total gastrectomy with D2 lymphadenectomy includes groups No.1 to No.7, No.8a, No.9, No.11p, No.11d, and No.12a. The No.4sa group lymph nodes are defined as the lymph nodes along the short gastric vessel, No.10 group lymph nodes are defined as the lymph nodes at the splenic hilum including the lymph nodes at the roots of the short gastric arteries. In routine total gastrectomy with D2 combined with CME surgery, the standard practice involves resection of the short gastric mesentery (No.4sa group and No. 10 group). There are typically 3-4 short gastric arteries in the human body, further investigation is required to determine the lymph node metastasis rates in each short gastric mesentery. Patients undergoing total gastrectomy with D2 combined with CME will have their short gastric mesenteries anatomically separated for examination, and this aims to analyze the positive rate of lymph nodes in the short gastric mesentery and investigate the correlation between tumor location, staging, and lymph node metastasis in the short gastric mesentery.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged older than 18 years and younger than 85 years
  • Primary gastric adenocarcinoma confirmed by preoperative pathology result
  • cT2-4aN0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  • Patients who received total gastrectomy with D2 lymphadenectomy plus complete mesogastric excision
  • American Society of Anesthesiologists (ASA) class I, II, or III
  • Written informed consent

排除标准

  • Negative preoperative biopsy
  • Too late tumour stage or metastasis (cT4b/M1)
  • BMI>30 kg/m2
  • previous neoadjuvant chemotherapy or radiotherapy
  • Previous upper abdominal surgery
  • Combined with other malignant diseases
  • Reject operation

结局指标

主要结局

Rate of lymph node metastasis and tumor deposit in the short gastric mesentery

时间窗: through study completion, an average of 1 year

次要结局

未报告次要终点

研究者

发起方
Jichao Qin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jichao Qin

Professor

First Affiliated Hospital of Zhejiang University

研究点 (1)

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