NCT00528632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 10, 2011

Status Verified

July 1, 2009

Enrollment Period

1.3 years

First QC Date

September 10, 2007

Last Update Submit

August 9, 2011

Conditions

GallstonesGallbladder Cholesterolosis

Keywords

GallstonesGallbladderCholesterolosisSerum cholesteroltriglyceridesBody Mass Index

Study Arms (2)

Cholesterolosis

I. Patients with gallbladder cholesterolosis and symptomatic cholelithiasis

Other: Specimen biopsy and serum laboratory tests

Cholelithiasis

II. Patients without gallbladder cholesterolosis and with symptomatic cholelithiasis

Other: Specimen biopsy and serum laboratory tests

Interventions

Specimen biopsy and serum laboratory testsOTHER

Biopsy of the surgical specimens (gallbladder) submitted after cholecystectomy Laboratory tests measuring levels of plasma total cholesterol and triglycerides

CholelithiasisCholesterolosis

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients operated on elective basis for symtomatic gallbladder lithiasis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital De La Serena

La Serena, Coquimbo Region, IV REGION, Chile

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Marcelo A Beltran, MD

    Hospital de La Serena

    PRINCIPAL INVESTIGATOR

  • Carlos Barria, MD

    Hospital De La Serena - HISTOMED

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 12, 2007

Study Start

March 1, 2008

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

August 10, 2011

Record last verified: 2009-07

Locations

CL(1)