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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02808546
Other study ID # 2015-L01-01
Secondary ID
Status Completed
Phase N/A
First received June 15, 2016
Last updated June 17, 2016
Start date January 2009
Est. completion date December 2015

Study information

Verified date June 2016
Source Cheju Halla General Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry for Health and Welfare
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 342
Est. completion date December 2015
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cheju Halla General Hospital

References & Publications (6)

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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol consumption Standard Dose Drink per week was used to compare the amount of alcohol consumption of each subjects Through study completion, an average of 1 year No
Secondary Obesity Obesity was defined as cases were scored more than 25 kg/square meter of Body Mass Index Through study completion, an average of 1 year No
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