Clinical trial NCT02808546: The Risk Factors of Symptomatic Gallbladder Stone: Age-Sex Matched Case-control Study Performed in Single Institute
Official title: The Risk Factors of Symptomatic Gallbladder Stone: Age-Sex Matched Case-control Study Performed in Single Institute
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallstone
Keywords: Gallbladder stone
Risk factor
Case-control study
Obesity
Hypertension
Alcohol consumption
Lead sponsor: Cheju Halla General Hospital
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 342
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case group was enrolled from the patients who were diagnosed as gallbladder stone disease with definite clinical symptoms and underwent cholecystectomy in Cheju Halla General Hospital, Jeju, Korea during 3 years (2009-2012). And control group was determined as 1:1 age-sex matched subjects selected from the participants without GBS among Health Promotion Center in the same institute and periods.

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Alcohol consumption
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Obesity
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Gastroenterology Consultant
name: Byung Hyo Cha, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banim PJ, Luben RN, Bulluck H, Sharp SJ, Wareham NJ, Khaw KT, Hart AR. The aetiology of symptomatic gallstones quantification of the effects of obesity, alcohol and serum lipids on risk. Epidemiological and biomarker data from a UK prospective cohort study (EPIC-Norfolk). Eur J Gastroenterol Hepatol. 2011 Aug;23(8):733-40. doi: 10.1097/MEG.0b013e3283477cc9.
citation: Cha BH. Epidemiological Characteristics of Gallbladder Cancer in Jeju Island: A Single-Center, Clinically Based, Age-Sex-Matched, Case-Control Study. Asian Pac J Cancer Prev. 2015;16(18):8451-4. doi: 10.7314/apjcp.2015.16.18.8451.
citation: Chow WH, McLaughlin JK, Menck HR, Mack TM. Risk factors for extrahepatic bile duct cancers: Los Angeles County, California (USA). Cancer Causes Control. 1994 May;5(3):267-72. doi: 10.1007/BF01830247.
citation: Little TJ, Horowitz M, Feinle-Bisset C. Role of cholecystokinin in appetite control and body weight regulation. Obes Rev. 2005 Nov;6(4):297-306. doi: 10.1111/j.1467-789X.2005.00212.x.
citation: Randi G, Franceschi S, La Vecchia C. Gallbladder cancer worldwide: geographical distribution and risk factors. Int J Cancer. 2006 Apr 1;118(7):1591-602. doi: 10.1002/ijc.21683.
citation: Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver. 2012 Apr;6(2):172-87. doi: 10.5009/gnl.2012.6.2.172. Epub 2012 Apr 17.