ClinicalTrials.gov
ClinicalTrials.gov Menu

Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00528632
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
Cirujanos la Serena

Brief Summary:

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.

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


Condition or disease Intervention/treatment
Gallstones Gallbladder Cholesterolosis Other: Specimen biopsy and serum laboratory tests

Detailed Description:

A prospective database including the following variables was filled out:

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

All elective patients older than 15 years of age submitted to cholecystectomy for symptomatic gallstones were included. Plasma cholesterol and triglycerides levels were measured 5 to 7 days before surgery. Only patients with chronic cholecystitis and with cholesterolosis according to the histology of the surgical specimen were included, we did not include any patient with acute cholecystitis or gallbladder cancer.


Study Type : Observational
Actual Enrollment : 406 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Association of Gallbladder Cholesterolosis to Body Mass Index and Levels of Serum Cholesterol and Triglycerides.
Study Start Date : March 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Cholesterolosis
I. Patients with gallbladder cholesterolosis and symptomatic cholelithiasis
Other: Specimen biopsy and serum laboratory tests

Biopsy of the surgical specimens (gallbladder) submitted after cholecystectomy

Laboratory tests measuring levels of plasma total cholesterol and triglycerides

Cholelithiasis
II. Patients without gallbladder cholesterolosis and with symptomatic cholelithiasis
Other: Specimen biopsy and serum laboratory tests

Biopsy of the surgical specimens (gallbladder) submitted after cholecystectomy

Laboratory tests measuring levels of plasma total cholesterol and triglycerides





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients operated on elective basis for symtomatic gallbladder lithiasis
Criteria

Inclusion Criteria:

  • Patients submitted to elective cholecystectomy
  • Histopathological report of gallbladder cholesterolosis
  • Histopathological report of chronic cholecystitis
  • Patients older than 15 years of age

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528632


Locations
Chile
Hospital De La Serena
La Serena, Iv Region, Chile, IV REGION
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

Responsible Party: MARCELO A. BELTRAN, MD, Hospital De La Serena
ClinicalTrials.gov Identifier: NCT00528632     History of Changes
Other Study ID Numbers: HLS-0012-09-07
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: July 2009

Keywords provided by Cirujanos la Serena:
Gallstones
Gallbladder
Cholesterolosis
Serum cholesterol
triglycerides
Body Mass Index

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical