Alcohol Consumption and Gallbladder Cancer

NCT02326948 | Completed

• 1 other identifier: 2014-L04
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallbladder Cancer

Keywords

Gallbladder cancer; Case-control study; Risk factor; Alcohol consumption; Polypoid lesions of gallbladder; Biliary stone

Outcome Measures

Primary Outcomes (1)

• Number of participants with alcohol consumption

  Up to 3 years

Other Outcomes (2)

• Number of participants with biliary stone diseases

  Up to 3 year

• Number of participants with polypoid lesions of gallbladder

  Up to 3 years

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cheju Halla General Hospital: lead

Study Sites (1)

Cheju Halla General Hopsital

Jeju City, Jeju Special Governing Province, 670-744, South Korea

Location

MeSH Terms

Conditions

Gallbladder Neoplasms; Alcohol Drinking; Cholecystolithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Drinking Behavior; Behavior; Cholelithiasis

Study Officials

• Byung Hyo Cha, M.D.

  Director of Digestive Disease Center, Department of Internal Medicine, Cheju Halla General Hospital, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Digestive Disease Center

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 30, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

KR (1)