GallstonesNCT00528632
Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides
An observational study of Gallstones and Gallbladder Cholesterolosis, run by Cirujanos la Serena at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Gallstones, Gallbladder Cholesterolosis
- What is being tested?
- Specimen biopsy and serum laboratory tests
- How many people
- 406 participants
- Where
- 1 siteChile
- Study dates
- Mar 2008to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients operated on elective basis for symtomatic gallbladder lithiasis
Who may be able to join
- Patients submitted to elective cholecystectomy
- Histopathological report of gallbladder cholesterolosis
- Histopathological report of chronic cholecystitis
- Patients older than 15 years of age
Who cannot join
- Patients younger than 15 years of age
- Pathological report missing from the hospital records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Gallbladder Cholesterolosis to Body Mass Index and Levels of Serum Cholesterol and Triglycerides.
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.
Read the 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.
- Conditions
- Gallstones, Gallbladder Cholesterolosis
- Being tested
- Specimen biopsy and serum laboratory tests
- Keywords
- Gallstones, Gallbladder, Cholesterolosis, Serum cholesterol, triglycerides, Body Mass Index
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Cholesterolosis | I. Patients with gallbladder cholesterolosis and symptomatic cholelithiasis Receives: Other: Specimen biopsy and serum laboratory tests | |
| Cholelithiasis | II. Patients without gallbladder cholesterolosis and with symptomatic cholelithiasis Receives: Other: Specimen biopsy and serum laboratory tests |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startMar 2008
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cirujanos la Serena
- Sponsor type
- University, hospital or other
- Investigators
- Marcelo A Beltran, MD, Principal investigator, Hospital de La SerenaCarlos Barria, MD, Study director, Hospital De La Serena - HISTOMED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528632
- Sponsor's protocol ID
- HLS-0012-09-07
- Status last verified
- Jul 2009
- First submitted
- 10 Sep 2007
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Gallbladder Cholesterolosis to Body Mass Index and Levels of Serum Cholesterol and Triglycerides.
- ClinicalTrials.gov ID
- NCT00528632
- Acronym / sponsor ID
- HLS-0012-09-07
- Conditions
- Gallstones, Gallbladder Cholesterolosis
- Keywords
- Gallstones, Gallbladder, Cholesterolosis, Serum cholesterol, triglycerides, Body Mass Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Cirujanos la SerenaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 12 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholesterolosis | – | Other: Specimen biopsy and serum laboratory testsI. Patients with gallbladder cholesterolosis and symptomatic cholelithiasis |
| Cholelithiasis | – | Other: Specimen biopsy and serum laboratory testsII. Patients without gallbladder cholesterolosis and with symptomatic cholelithiasis |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients operated on elective basis for symtomatic gallbladder lithiasis
Key inclusion criteria (4 listed)
- Patients submitted to elective cholecystectomy
- Histopathological report of gallbladder cholesterolosis
- Histopathological report of chronic cholecystitis
- Patients older than 15 years of age
Key exclusion criteria (2 listed)
- Patients younger than 15 years of age
- Pathological report missing from the hospital records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specimen biopsy and serum laboratory testsBiopsy of the surgical specimens (gallbladder) submitted after cholecystectomy Laboratory tests measuring levels of plasma total cholesterol and triglycerides | Other | Cholelithiasis, Cholesterolosis |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo A Beltran, MD principal investigator
Hospital de La Serena
Carlos Barria, MD study director
Hospital De La Serena - HISTOMED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstones and Gallbladder Cholesterolosis, run by Cirujanos la Serena at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2011.