Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides - Full Text View

Sponsored by:	Cirujanos la Serena
Information provided by:	Cirujanos la Serena
ClinicalTrials.gov Identifier:	NCT00528632

Purpose

Cholesterolosis is a common finding in biopsy specimens of gallbladders surgically removed for cholelithiasis.

To the best of the investigators knowledge no study has analyzed the relationships of Body Mass Index, serum Cholesterol and Triglycerides and gallbladder cholesterolosis, and its possible relationship to gallbladder cancer.

The purpose of this study is to analyze and find relations between gallbladder cholesterolosis, Body Mass Index, serum cholesterol and triglycerides, and its possible relationship to gallbladder cancer.

Condition	Intervention
Gallstones Gallbladder Cholesterolosis	Other: Biopsies and Laboratory tests

Study Type:	Observational
Study Design:	Case Control, Retrospective
Official Title:	Association of Gallbladder Cholesterolosis to Body Mass Index and Levels of Serum Cholesterol and Triglycerides, and Its Possible Relationship to Gallbladder Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cholesterol Gallbladder Cancer Gallstones

Drug Information available for: Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Further study details as provided by Cirujanos la Serena:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
I I. Patients with Gallbladder Cholesterolosis	Other: Biopsies and Laboratory tests Biopsy Laboratory tests
II II. Patients without Gallbladder Cholesterolosis	Other: Biopsies and Laboratory tests Biopsy Laboratory tests

Detailed Description:

Age
Gender
Diagnosis
Weight
Height
Body Mass Index
Histopathological results (Biopsy)
Serum cholesterol
Serum triglycerides

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients operated on elective or emergency basis for gallbladder lithiasis

Criteria

Inclusion Criteria:

Patients submitted to elective or emergency cholecystectomy
Histopathological report of gallbladder cholesterolosis
Histopathological report of chronic cholecystitis
Patients older than 15 years of age
Gallbladder cancer incidentally found with cholesterolosis
Gallbladder cancer electively operated on with cholesterolosis

Exclusion Criteria:

Patients younger than 15 years of age
Pathological report missing from the hospital records

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528632

Contacts

Contact: Marcelo A Beltran, MD

56-51-200-704

beltran_01@yahoo.com

Locations

Chile, IV REGION
Hospital De La Serena	Recruiting
La Serena, IV REGION, Chile, IV REGION
Contact: Marcelo A Beltran, MD 51-56-200-704 beltran_01@yahoo.com
Principal Investigator: Marcelo A Beltran, MD
Sub-Investigator: Carlos Barria, MD

Sponsors and Collaborators

Cirujanos la Serena

Investigators

Principal Investigator:	Marcelo A Beltran, MD	Hospital De La Serena
Study Director:	Carlos Barria, MD	Hospital De La Serena - HISTOMED

More Information

No publications provided

Responsible Party:	Hospital De La Serena ( MARCELO A. BELTRAN, MD )
Study ID Numbers:	HLS-0012-09-07
Study First Received:	September 10, 2007
Last Updated:	June 15, 2009
ClinicalTrials.gov Identifier:	NCT00528632 History of Changes
Health Authority:	Chile: Instituto de Salud Publica de Chile

Keywords provided by Cirujanos la Serena:

Gallstones
Gallbladder
Cholesterolosis

Serum cholesterol
triglycerides
Body Mass Index

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Gall Bladder Cancer
Digestive System Diseases

Cholelithiasis
Gallstones
Biliary Tract Diseases
Gallbladder Neoplasms
Calculi

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Digestive System Diseases

Cholelithiasis
Gallstones
Biliary Tract Diseases
Calculi

ClinicalTrials.gov processed this record on July 06, 2009