Multicenter Prospective Cohort Study of Risk Factors for Gallbladder Cancer

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of benign gallbladder disease; according to the national epidemiology of gallbladder cancer Center Clinical Research (unpublished), 2000 National Cholecystoma Clinical Epidemiology Report, and 2005 Clinical Analysis of 2379 Cases of Gallbladder Carcinoma in 17 Hospitals in Five Northwest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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Gallbladder Diseases
• Intervention / Treatment: Other: Benigh gallbladder diseases

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 100000

Contacts and Locations

• Study Contact: Name: Jianming Wang, PHD; Phone Number: +86 13507188252; Email: wjm18jgm@aliyun.com
• Study Contact Backup: Name: Yun Lu, MD; Phone Number: +86 13971543825; Email: drlyly@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The recruits included patients with benign gallbladder cancer and healthy people, mainly from the Grade-A Tertiary Hospitals and medical centers in China.

Description

Inclusion Criteria:

• Subjects who met the following four criteria entered the study.

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

Exclusion Criteria:

• Subjects can not enter the study by combining any of the following

  1. Concomitant diseases such as severe mental illness, severe heart, lung and kidney;
  2. Refusal of follow-up requirements.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposure group：Benign gallbladder disease; Patients with benign gallbladder diseases, such as gallbladder polyps, gallstones, etc.	Other: Benigh gallbladder diseases; We aim to observe the relationship between the benigh gallbladder diseases and gallbladder cancer, and we will not take any actions to interrupt.
Non-exposed group: healthy people; Patients without benign gallbladder diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gallbladder cancer	Comparison of incidence of gallbladder cancer between the two groups	3 years

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2029

Study Registration Dates

• First Submitted: December 2, 2018
• First Submitted That Met QC Criteria: December 2, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): March 4, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Gallbladder cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms; Gallbladder Neoplasms; Gallbladder Diseases
• Other Study ID Numbers: TJ-IRB20181109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No