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NCT02326948 Clinical Trial

Alcohol Consumption and Gallbladder Cancer

Gallbladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02326948
Other study ID # 2014-L04
Secondary ID
Status Completed
Phase N/A
First received December 19, 2014
Last updated December 29, 2014
Start date August 2014
Est. completion date November 2014

Study information
Verified date December 2014
Source Cheju Halla General Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 156
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Cheju Halla General Hopsital Jeju-si Jeju special governing province

Sponsors (1)
Lead Sponsor Collaborator
Cheju Halla General Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other Number of participants with biliary stone diseases Up to 3 year No
Other Number of participants with polypoid lesions of gallbladder Up to 3 years No
Primary Number of participants with alcohol consumption Up to 3 years No
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