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

Gallstone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808546
• Other study ID #: 2015-L01-01
• 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

• Cholecystolithiasis
• Cholelithiasis
• Gallstone
• Gallstones

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