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

NCT02808546 | Completed DMC

• 1 other identifier: 2015-L01-01
• Study Type: observational
• Target: 342
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gallstone

Keywords

Gallbladder stone; Risk factor; Case-control study; Obesity; Hypertension; Alcohol consumption

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Obesity

  Through study completion, an average of 1 year

Study Arms (2)

Case Group

All the patients who were diagnosed as gallbladder stone disease with definite clinical symptoms and underwent cholecystectomy in Cheju Halla General Hospital, Jeju, Korea during 2009-2013

Control Group

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Clinical diagnosis of gallstone disease after cholecystectomy.

You may not qualify if:

• Ambiguous diagnosis cases for gallbladder stone.
• Incomplete medical record.
• Control group
• Healthy examinees in Health Promotion Center in same Institute
• Eligible cases of abdominal ultrasound(US) or computed tomography(CT)
• The case who was diagnosed as asymptomatic gallstone on abdominal US

Sponsors & Collaborators

• Cheju Halla General Hospital: lead

Related 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.

  PMID: 21623190 BACKGROUND

• 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.

  PMID: 26745100 BACKGROUND

• 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.

  PMID: 8061176 BACKGROUND

• 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.

  PMID: 16246215 BACKGROUND

• 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.

  PMID: 16397865 BACKGROUND

• 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.

  PMID: 22570746 BACKGROUND

MeSH Terms

Conditions

Gallstones; Cholecystolithiasis; Obesity; Hypertension; Alcohol Drinking

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Drinking Behavior; Behavior

Study Officials

• Byung Hyo Cha, M.D.

  Gastroenterology Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Consultant, Representative of Digestive Disease Center

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 21, 2016
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: June 21, 2016

Record last verified: 2016-06