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临床试验/NCT03762837
NCT03762837尚未招募不适用

Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer

Tongji Hospital0 个研究点目标入组 100,000 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100,000
主要终点
Gallbladder cancer

研究概览

简要总结

This trial is a prospective study, the main purpose of the study is to investigate the association between benign gallbladder disease and gallbladder carcinoma; to explain the timing of intervention, intervention and early prevention of benign gallbladder disease; according to the national epidemiology of gallbladder cancer Center Clinical Research (unpublished), 2000 National Cholecystoma Clinical Epidemiology Report, and 2005 Clinical Analysis of 2379 Cases of Gallbladder Carcinoma in 17 Hospitals in Five Northwest Provinces, Pre-experimental data, using samples The volume estimation formula, α = 0.05, β = 0.1, plans to enroll 100,000 people.Half of participants is someone with Biliary benign disease,while the other half is healthy.

详细描述

Gallbladder cancer is the most common malignant biliary tract tumor. The main risk factors for gallbladder cancer include gallstones, gallbladder polyps, gallbladder adenomas, chronic inflammation of the gallbladder, etc. However, recently, there is still a lack of evaluation data on relevant risk factors. Therefore, on the basis of large-scale epidemiological investigations, large-scale prospective studies are needed to further clarify the level of risk factors associated with gallbladder cancer. With the development of modern imaging technology and deep understanding of gallbladder diseases, the detection rate of benign gallbladder lesions (cacerous polyps, gallbladder adenomyosis, gallbladder adenoma, gallstones, etc.) has increased year by year, and some benign gallbladder lesions can pass A series of pathophysiological processes have gradually evolved into gallbladder cancer. This study aimed to establish a prospective cohort of benign gallbladder disease, to explore the correlation, intervention time and socioeconomic benefits of benign gallbladder disease and gallbladder cancer. In order to further understand the current trend and diagnosis and treatment of benign gallbladder disease in China, the Chinese Society of Surgery Branch of the Chinese Society of Surgery will launch a national epidemiological survey of gallbladder cancer (2018). This study will provide a more detailed basis for the diagnosis and treatment of benign gallbladder disease in China.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who met the following four criteria entered the study.
  • A benign gallbladder disease is detected during a medical examination or visit (according to any imaging test);
  • healthy people without gallbladder disease;
  • Age greater than 18 years and less than 80 years old;
  • Sign the informed consent form. PS: If someone meets the condition (1) or (2), then he can be enrolled.

排除标准

  • Subjects can not enter the study by combining any of the following
  • Concomitant diseases such as severe mental illness, severe heart, lung and kidney;
  • Refusal of follow-up requirements.

结局指标

主要结局

Gallbladder cancer

时间窗: 3 years

Comparison of incidence of gallbladder cancer between the two groups

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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