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临床试验/NCT03791268
NCT03791268Unknown不适用

The Establishment of General Tissue Response Classification System After Chemotherapy According to Gastric Cancer Patients With Neoadjuvant Chemotherapy

West China Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
General observation of tissue fibrosis, edema and exudation (Intraoperation)

研究概览

简要总结

This research intend to collect the information of gastric cancer patients who received preoperative neoadjuvant chemotherapy and radical gastric ectomy at Department of Gastrointestinal Surgery, West China Hospital, Sichuan University. Base on The degree of edema, intraoperative effusion, fibrosis of connecting tissues, the investigators aim to constitute the core parameters of the tissue response grading system following neoadjuvant chemotherapy, and explore the mutual effect among the tissue response grading system, tumor regression response and long-term survival outcome of tumor patients.

详细描述

Gastric cancer is ranked the third malignancy carcinoma which related deaths. In china, gastric cancer always ranked in the top three cancer-related deaths. Early diagnosis ratio of gastric caner is low in china. And the proportion of gastric cancer cases which performed surgical treatment is less than 20% at early stage Therefore, the vast majority of patients with gastric carcinoma already have locally advanced tumors at the time of diagnosis in china, and the current treatment strategy is suggested to receive comprehensive surgical gastrectomy. Current research showed strong evidence that preoperative neoadjuvant therapy represented by neoadjuvant chemotherapy (NAC) can downstaging the primary tumor to increase the possibility of a successful complete resection and destroying occult lymph node and distant micro metastases to decrease the rate of tumor recurrence., and thus provide the survival benefit for locally advanced gastric cancer patients.Therefore, the national comprehensive cancer network(NCCN)guidelines for gastric cancer treatment(2017 version 5),recommended that neoadjuvant chemotherapy (evidential level category 1 ) and neoadjuvant chemotherapy (evidential level category 2B) can be considered.for locally advanced gastric caner cases(T2-4nx).

Through the literature review, the investigators found that residual tumor evaluation criteria which was promoted by Becker and the criteria for tumor regression response which recommended by NCCN guidelines can be used to evaluate the tumor regression after chemotherapy/radiotherapy. However, the rating criteria for connective tissue response around the tumor after chemotherapy/radiotherapy still remain blank area. During the clinical practice, surgeons should not ignored the edema and fibrosis of tumor and connective tissue after chemotherapy/radiotherapy which existed objectively. Recent research generally believed that preoperative chemotherapy with/or not with radiotherapy may lead to edema of gastrointestinal tract and perigastric tissues, intraoperative effusion and fibrosis of tumor and lymph nodes bearing tissues,which may increase the difficulty of tissue dissociation and lymph node dissection, increase the risk of surgical trauma, and may lead to increased incidence of postoperative complications. There is till a lack of evaluation criteria for the degree of tissue fibrosis/edema after radiotherapy and chemotherapy which may have impact on surgery and long-term survival prognosis of patients.

Therefore, it is necessary to analyze and evaluate tissue edema and fibrosis after chemotherapy/radiotherapy and establish corresponding criteria system to explore whether if the tissue fibrosis and edema are involved with the degree of tumor retreat after chemotherapy/radiotherapy at two aspects: general evaluation and histopathology. The interaction effects of tissue fibrosis and edema with the difficulty of operation and incidence rate of postoperative complications. In addition, the mutual effect of tissue fibrosis and edema with the final long-term survival outcome of tumor patients needs to be evaluated from two aspects: general observation and histopathology evaluation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The diagnosis of gastric cancer was clear,Patients with definitely clinical evidence of locally advanced disease (cT3 ⁄ 4、N-/+、M0).
  • Preoperative chemotherapy has been administered,and intended to receive surgical resection.
  • Age:less than or equal to 75 years old and more than 18 years old;
  • Without any other malignant tumor, without any serious concomitant disease.
  • Eastern Cooperative Oncology Group (ECOG) physical status score <2, America Society of Anesthesiologist (ASA) score<3
  • No restriction on gender or race; Informed consent has been signed by patient or entrusted agent;

排除标准

  • Previous history of gastric ulcer or gastric perforation;
  • Previous operation history at upper abdominal, except laparoscopic cholecystectomy;
  • Emergency operation caused by obstruction, perforation,and acute hemorrhage;
  • The patient can not tolerate the surgical treatment which caused by other serious concomitant disease, such as severe pulmonary disease, cardiac clinical function below are below level 2, pulmonary infection, moderate or severe chronic obstructive pulmonary disease (COPD), chronic bronchitis
  • Patient has severe mental illness
  • The patient and agent request to withdraw from the clinical study after signing the consent form.

结局指标

主要结局

General observation of tissue fibrosis, edema and exudation (Intraoperation)

时间窗: The 1 day of surgery

To assess the degree of fibrosis, edema and exudation in tumor tissue and main perigastric lymph node area during the operation.

次要结局

  • Histopathology evaluation of tissue fibrosis(Postoperative 30 days)
  • General observation of tissue edema (Intraoperation)(The 1 day of surgery)
  • Postoperative mortality rate(Postoperative 30 days)
  • Histopathology evaluation of edema(The 1 day of surgery)
  • General observation of tissue exudation (Intraoperation)(The 1 day of surgery)
  • Survival outcome(Postoperative 3 Years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jian-Kun Hu

Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital

West China Hospital

研究点 (1)

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