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CompletedNCT02808546Updated Jun 21, 2016

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

An observational study in Gallstone, sponsored by Cheju Halla General Hospital. Completed. Per ClinicalTrials.gov, last updated 2016-06-21.

Sponsored by Cheju Halla General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
342
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Gallstone

Keywords

  • Gallbladder stone
  • Risk factor
  • Case-control study
  • Obesity
  • Hypertension
  • Alcohol consumption
03

In context

Gallstones

346 studies on the registry are indexed under Gallstones; 46 are open to participants now.

This study's enrollment of 342 is above the median of 200 across 102 observational studies indexed under Gallstones.

Browse Gallstones studies →

Lead sponsor

Cheju Halla General Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
342 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Alcohol consumption

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

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

Secondary outcomes

  1. Obesity

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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 21623190 ↗
  • 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. PubMed 26745100 ↗
  • 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. PubMed 8061176 ↗
  • 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. PubMed 16246215 ↗
  • 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. PubMed 16397865 ↗
  • 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. PubMed 22570746 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02808546
Lead sponsor
Cheju Halla General Hospital
Responsible party
Byung Hyo Cha, MD (Gastroenterology Consultant, Representative of Digestive Disease Center, Cheju Halla General Hospital) — Principal investigator
First posted
Jun 21, 2016
Start date
Jan 2009
Primary completion
Dec 2013
Completion
Dec 2015
Last update
Jun 21, 2016

Study contacts

Byung Hyo Cha, M.D.
principal investigator · Gastroenterology Consultant

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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