Gallbladder DiseasesNCT00388830
Emergency Ultrasound of the Gallbladder
A study testing Ultrasound in people with Gallbladder Diseases, run by Christiana Care Health Services at 1 site in United States.
Trial summary
The purpose of this study is to determine whether fasting for 8 hours prior to ultrasonography for cholelithiasis (gallbladder pain) is needed. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gallbladder Diseases
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jul 2007
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between the ages of 18 and 75
- Ability to consent for study
Who cannot join
- Inability to give informed consent
- Known pregnancy
- Prior cholecystectomy
- Inability to consume a fast food breakfast
- Known history of cholelithiasis
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health Services
Newark, Delaware, 19718
About this study
Official title: "Emergency Bedside Ultrasonography of the Gallbladder: Does Fasting Matter?"
The purpose of this study is to determine whether fasting for 8 hours prior to ultrasonography for cholelithiasis (gallbladder pain) is needed.
Read the detailed description
Ultrasonography of the gallbladder is currently the diagnostic modality of choice in determining cholelithiasis and cholecystitis. Historically this test has been performed in the Radiology suites where the patient was expected to fast for times of six to ten hours. Patients presenting to emergency departments (ED) have also been required to wait to have their study performed in order to have better visualization of the gallbladder. However, few studies have examined whether a fasting time matters in determining gallbladder pathology. Furthermore, with the emphasis on through-times in the ED, most EDs cannot afford holding their patients in the ED to wait for a test. Finally, with the advent of emergency bedside ultrasonography and the greater level of comfort emergency physicians (EP) have in diagnosing gallbladder pathology, it is possible to now determine an answer within minutes. We will test to see if EPs trained in the use of emergency bedside ultrasound can effectively and efficiently determine gallbladder pathology and if fasting has an impact on their ability to perform a quality ultrasound.
- Conditions
- Gallbladder Diseases
- Being tested
- Ultrasound
- Keywords
- Gallbladder, Ultrasound, Emergency Medicine
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
time to perform scan
diagnosis of pathology
performance of adequate measurement
overall adequacy of the scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startMay 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Investigators
- Robert O'Connor, MD, MPH, Study director, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388830
- Sponsor's protocol ID
- 26046
- Status last verified
- Nov 2012
- First submitted
- 13 Oct 2006
- Last updated
- 2 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Emergency Bedside Ultrasonography of the Gallbladder: Does Fasting Matter?"
- ClinicalTrials.gov ID
- NCT00388830
- Acronym / sponsor ID
- 26046
- Conditions
- Gallbladder Diseases
- Keywords
- Gallbladder, Ultrasound, Emergency Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 17 Oct 2006 (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.
The purpose of this study is to determine whether fasting for 8 hours prior to ultrasonography for cholelithiasis (gallbladder pain) is needed.
Detailed description
Ultrasonography of the gallbladder is currently the diagnostic modality of choice in determining cholelithiasis and cholecystitis. Historically this test has been performed in the Radiology suites where the patient was expected to fast for times of six to ten hours. Patients presenting to emergency departments (ED) have also been required to wait to have their study performed in order to have better visualization of the gallbladder. However, few studies have examined whether a fasting time matters in determining gallbladder pathology. Furthermore, with the emphasis on through-times in the ED, most EDs cannot afford holding their patients in the ED to wait for a test. Finally, with the advent of emergency bedside ultrasonography and the greater level of comfort emergency physicians (EP) have in diagnosing gallbladder pathology, it is possible to now determine an answer within minutes. We will test to see if EPs trained in the use of emergency bedside ultrasound can effectively and efficiently determine gallbladder pathology and if fasting has an impact on their ability to perform a quality ultrasound.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female between the ages of 18 and 75
- Ability to consent for study
Key exclusion criteria (5 listed)
- Inability to give informed consent
- Known pregnancy
- Prior cholecystectomy
- Inability to consume a fast food breakfast
- Known history of cholelithiasis
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 |
|---|---|---|
| Ultrasound | Procedure or surgery | – |
Primary outcome
time to perform scan
diagnosis of pathology
performance of adequate measurement
overall adequacy of the scan
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 2 Nov 2012.
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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.
Robert O'Connor, MD, MPH study director
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Gallbladder Diseases, run by Christiana Care Health Services at 1 site in United States.
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 2 inclusion and 5 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 2 Nov 2012. 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 United States. 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.
What does the primary outcome measure?
time to perform scan. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 2 Nov 2012.