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Completed

NCT Number: NCT02808546

The Risk Factors of Symptomatic Gallbladder Stone: Age-Sex Matched Case-control Study Performed in Single Institute

The main purpose of this study is to investigate the region-specific cause of gallbladder stone incidence in Jeju Self-Governing Province, Korea.

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Key information

Conditions

Gallstone Alcohol Drinking Behavior Biliary Tract Diseases Body Weight Calculi Cardiovascular Diseases Cholecystolithiasis Cholelithiasis Digestive System Diseases Drinking Behavior Gallbladder Diseases Gallstones Hypertension Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

Investigators performed the epidemiologic study to uncover the reason of relatively higher incidence of Gallbladder cancer in small isolated island, Jeju island, one of small province among 11 self governing area in South Korea. Tow studies, including descriptive epidemiology and analytic epidemiology using case-control study, some risk factors were obtained regarding Gallbladder cancer development in this area. Old age, female, and gallstone were potential risk factors and alcohol consumption was preventive factors. So authors decided to evaluate the relationship between alcohol and gallbladder stone in order to how much portion of causal relationship they have with gallbladder cancer. So this study was designed to investigate the relationship between gallbladder stone and alcohol consumption then performed clinical based case-control study with age-sex matching to each subjects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Case group

Inclusion criteria

  • Clinical diagnosis of gallstone disease after cholecystectomy.

Exclusion criteria

  • Ambiguous diagnosis cases for gallbladder stone.
  • Incomplete medical record.

Control group

Inclusion criteria

  • Healthy examinees in Health Promotion Center in same Institute
  • Eligible cases of abdominal ultrasound(US) or computed tomography(CT)

Exclusion criteria

  • The case who was diagnosed as asymptomatic gallstone on abdominal US

Treatment and study plan

Primary outcomes

  1. Alcohol consumption

    Time frame: Through study completion, an average of 1 year

    Standard Dose Drink per week was used to compare the amount of alcohol consumption of each subjects

Secondary outcomes

  1. Obesity

    Time frame: Through study completion, an average of 1 year

    Obesity was defined as cases were scored more than 25 kg/square meter of Body Mass Index

Sponsors and collaborators

Lead sponsor

Cheju Halla General Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
Jun 21, 2016
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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