Clinical trial NCT02326948: Alcohol Consumption and Gallbladder Cancer
Official title: Alcohol Consumption and Gallbladder Cancer: Case-control Study in Jeju Island, Korea.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallbladder Cancer
Keywords: Gallbladder cancer
Case-control study
Risk factor
Alcohol consumption
Polypoid lesions of gallbladder
Biliary stone
Lead sponsor: Cheju Halla General Hospital
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 156
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 defined as the patients newly diagnosed GBC at the Digestive Disease Center and Department of Internal Medicine, Cheju Halla General Hospital, Jeju, Korea, during 2008 - 2013. And control groups were determined the randomly 1:1 matched subjects by the age and sex distributions of GBC cases, among the health care check-up examinees visited to Health Promotion Center in the same institute and same periods. Total 78 cases among 124 GBC patients and matched 78 controls from 7088 health check-up examinees were included this study.

Brief summary: This case-control study matched by age and sex was performed to evaluate the region specific risk factors for gallbladder cancer in Jeju island, Korea.

Detailed description: In order to estimate region-specific risk factors for gallbladder cancer (GBC) in Jeju island, Korea the investigators performed a case-control study. Among 124 GBC patients and 7088 health controls, the investigators randomly selected 78 cases and 78 age-sex matched controls (1:1 matching) and compared their demographic features, combined diseases, and personal histories about known risk factors until now.

Eligibility criteria: Inclusion Criteria:

* Case group : newly diagnosed gallbladder cancer patients in Digestive Disease Center, Department of Internal Medicine in Cheju Halla General Hospitalduring 2008-2013
* Control group : 1:1 age-sex matched controls underwent health care screening program in Department of Health Promotion Center in Cheju Halla General Hospital for 2008-2012.

Exclusion Criteria:

* Case group Ambiguous diagnosis primary tumor involving common bile duct follow up loss without pathologic confirmation Incomplete clinical records Couldn't be assessed the results of operation or radiologic imaging.
* Control group Cases unavailable for gallbladder imaging (abdominal ultrasonography ,computed tomography, or magnetic resonance imaging) Cases underwent previous cholecystectomy before enrollment.

Primary outcomes:
measure: Number of participants with alcohol consumption
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
measure: Number of participants with biliary stone diseases
timeFrame: Up to 3 year
measure: Number of participants with polypoid lesions of gallbladder
timeFrame: Up to 3 years
Locations:
city: Jeju-si
country: Korea, Republic of
facility: Cheju Halla General Hopsital
state: Jeju special governing province
Study officials:
affiliation: Director of Digestive Disease Center, Department of Internal Medicine, Cheju Halla General Hospital, Korea
name: Byung Hyo Cha, M.D.
role: PRINCIPAL_INVESTIGATOR
References: