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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of benign gallbladder disease; according to the national epidemiology of gallbladder cancer Center Clinical Research (unpublished), 2000 National Cholecystoma Clinical Epidemiology Report, and 2005 Clinical Analysis of 2379 Cases of Gallbladder Carcinoma in 17 Hospitals in Five Northwest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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure group:Benign gallbladder disease | Patients with benign gallbladder diseases, such as gallbladder polyps, gallstones, etc. |
| |
| Non-exposed group: healthy people | Patients without benign gallbladder diseases |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benigh gallbladder diseases | Other | We aim to observe the relationship between the benigh gallbladder diseases and gallbladder cancer, and we will not take any actions to interrupt. |
| Measure | Description | Time Frame |
|---|---|---|
| Gallbladder cancer | Comparison of incidence of gallbladder cancer between the two groups | 3 years |
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Inclusion Criteria:
Subjects who met the following four criteria entered the study.
Exclusion Criteria:
Subjects can not enter the study by combining any of the following
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The recruits included patients with benign gallbladder cancer and healthy people, mainly from the Grade-A Tertiary Hospitals and medical centers in China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianming Wang, PHD | Contact | +86 13507188252 | wjm18jgm@aliyun.com | |
| Yun Lu, MD | Contact | +86 13971543825 | drlyly@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2018 | Feb 23, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2018 | Feb 23, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |