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临床试验/NCT04250402
NCT04250402已完成不适用

The Incidence Risks of Gallstones After Radical Surgery in Different Types of Gastric Cancer

Hepatopancreatobiliary Surgery Institute of Gansu Province2 个研究点 分布在 1 个国家目标入组 1,019 人开始时间: 2020年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,019
试验地点
2
主要终点
Number of gallstone patients

研究概览

简要总结

Through previous clinical observations and literature, we found that the incidence of gallstones in patients after gastric cancer radical resection was significantly higher than that in the normal population (4%). However, its pathogenesis has not been clarified. We compare the risk of gallbladder stones after four different radical gastric cancer surgical methods, in order to provide prevention and treatment strategies for people with gallstones after gastric cancer.

详细描述

A large number of clinical studies have found that the incidence of gallstones in patients with radical gastric cancer is higher than that in the normal population. However, its pathogenesis has not been clarified, and there is still controversy about the prophylactic removal of gallbladder in patients with gastric cancer. The investigator's previous study found that there was no statistical difference in the incidence of gallstones after laparoscopic distal gastrectomy (LDG), laparoscopic total gastrectomy (LTG) and laparoscopic proximal gastrectomy (LPG). A common feature of the three surgical methods is that the vagus nerve were more or less cut during the operation. Therefore, we plan to further collect gastric cancer patients undergoing endoscopic submucosal dissection (ESD) surgery in order to answer whether the vagus nerve cut during surgery will increase the incidence of gallstones.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Gastric cancer patients
  • Age from over 18 to under 75 years

排除标准

  • Gallbladder disease before surgery
  • Gallbladder has been remove
  • History of previous upper abdominal surgery
  • History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  • History of other malignant disease within past five years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • Pregnant women or breastfeeding
  • Unwillingness or inability to consent for the study
  • Severe mental disorder
  • Unstable vital signs Coagulation dysfunction (INR>1.5)
  • Low peripheral blood platelet count (<50×10 ^9 / L) or using anti- coagulation drugs

结局指标

主要结局

Number of gallstone patients

时间窗: 3 years

Four different gastric cancer patients were followed up for more than 1 year. The number of patients with gallbladder stones revealed by B-ultrasound

次要结局

  • Number of malignant metastasis(3 years)
  • Number of physical regurgitation, nausea, vomiting, diarrhea, constipation(3 years)
  • Number of short-term deaths(3 months)

研究者

发起方
Hepatopancreatobiliary Surgery Institute of Gansu Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wenbo Meng

Direct of surgery

Hepatopancreatobiliary Surgery Institute of Gansu Province

研究点 (2)

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