Alcohol Consumption and Gallbladder Cancer

December 29, 2014 updated by: Byung Hyo Cha, MD, Cheju Halla General Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeju special governing province
      • Jeju-si, Jeju special governing province, Korea, Republic of, 670-744
        • Cheju Halla General Hopsital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with alcohol consumption
Time Frame: Up to 3 years
Up to 3 years

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants with biliary stone diseases
Time Frame: Up to 3 year
Up to 3 year
Number of participants with polypoid lesions of gallbladder
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

December 29, 2014

First Posted (Estimate)

December 30, 2014

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-L04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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