Alcohol Consumption and Gallbladder Cancer

Sponsor

Cheju Halla General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02326948

Collaborator

(none)

156

Enrollment

Location

Duration (Months)

51.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gallbladder Cancer

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.

Study Design

Study Type:

Observational

Actual Enrollment :

156 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Alcohol Consumption and Gallbladder Cancer: Case-control Study in Jeju Island, Korea.

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Gallbladder cancer case group Gallbladder cancer case group was defined as newly diagnosed gallbladder cancer diagnosed as GBC at the Department of Internal Medicine in Cheju Halla General Hospital, Jeju, Korea from 2009 to 2013.
Age and sex matched control group Age and sex matched control group was determined as age-sex matched subjects selected from the participants of Health Promotion Center in the same institute from 2009 to 2012.

Outcome Measures

Primary Outcome Measures

Number of participants with alcohol consumption [Up to 3 years]

Other Outcome Measures

Number of participants with biliary stone diseases [Up to 3 year]
Number of participants with polypoid lesions of gallbladder [Up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cheju Halla General Hopsital	Jeju-si	Jeju special governing province	Korea, Republic of	670-744

Sponsors and Collaborators

Cheju Halla General Hospital

Investigators

Principal Investigator: Byung Hyo Cha, M.D., Director of Digestive Disease Center, Department of Internal Medicine, Cheju Halla General Hospital, Korea