Gall Bladder PainNCT05587933
Ejection Fraction of Normal Gall Bladder on Ultrasonography in Patients With Biliary Colic: Is it a Predictor of Cholecystectomy?
A study testing cholecystectomy and Antispasmodic in people with Gall Bladder Pain and Hepatobiliary Iminodiacetic Acid, run by Assiut University.
Trial summary
In this study investigators aim to evaluate gallbladder ejection fraction as a predictor for cholecystectomy. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gall Bladder Pain, Hepatobiliary Iminodiacetic Acid, Acalculous Cholecystitis
- What is being tested?
- cholecystectomy and Antispasmodic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2022to 1 Jul 2023
- 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 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients older than 14 years of age
- food-related abdominal pain
- normal gallbladder ultrasound (US)
- GB EF 80% and greater or 35% and less on HIDA scan with CCK injection
Who cannot join
- Patients younger than 14 years old
- Patients with the positive US defined as the presence of gallstones, gallbladder wall thickening (> 4 mm), pericholecystic fluid, sludge, or polyps
- Normal GB EF
About this study
In this study investigators aim to evaluate gallbladder ejection fraction as a predictor for cholecystectomy.
Read the detailed description
The flow of bile through the biliary system is a complex process that depends on the hormonal environment, digestive phase, and functional response of the gallbladder and sphincter of Oddi to all of these factors. Biliary dyskinesia is a disorder of some component of biliary part of the digestive system in which bile cannot physically flow in the proper direction through the tubular biliary tract which causes biliary colic as defined by Rome IV criteria.
Functional causes of biliary pain, also referred to as biliary dyskinesia, are biliary hypokinesia , biliary hyperkinesia and sphincter of Oddi dysfunction (SOD). The exact pathology of functional biliary colic is still unknown. Reviewing Literature status, There is still some debate about the best method to establish the diagnosis gallbladder dyskinesia and hyperkinesia and whether or not ejection fraction is an accurate predictor of outcome. Which led to difficult.
Biliary dyskinesia is identified through gallbladder ejection fraction (GBEF), which is calculated as the flow of radioactive tracer that is ejected from the gallbladder. A GBEF of <35% is considered dyskinesia and a GBEF of <35% is considered hyperkinesia. Patients considered for CCK-HIDA (cholecystokinin hepatobiliary iminodiacetic acid) are those presenting with functional biliary pain based on the Rome IV criteria. Those who present with atypical pain may not need as HIDA (hepatobiliary iminodiacetic acid) as the presentation may be from other pathology.
- Being tested
- cholecystectomy, Antispasmodic
- Medical subject headings
- Acalculous Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecystectomyProcedure or surgery
cholecystectomy
AntispasmodicDrug
Antispasmodic
| Study group | Role | What they receive |
|---|---|---|
| operative | Experimental | Not described Receives: Procedure: cholecystectomy; Drug: Antispasmodic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of quality of life improvment after cholecystectomy according to ROME IV criteria
abdominal pain, nausea and vomiting
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start25 Oct 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gall Bladder PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Yassien Abd-Elkariem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587933
- Sponsor's protocol ID
- GB EF biliary colic normal US
- Status last verified
- Oct 2022
- First submitted
- 24 Sep 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ejection Fraction of Normal Gall Bladder on Ultrasonography in Patients With Biliary Colic: Is it a Predictor of Cholecystectomy?
- ClinicalTrials.gov ID
- NCT05587933
- Acronym / sponsor ID
- GB EF biliary colic normal US
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Oct 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 20 Oct 2022 (actual)
- 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.
In this study investigators aim to evaluate gallbladder ejection fraction as a predictor for cholecystectomy.
Detailed description
The flow of bile through the biliary system is a complex process that depends on the hormonal environment, digestive phase, and functional response of the gallbladder and sphincter of Oddi to all of these factors. Biliary dyskinesia is a disorder of some component of biliary part of the digestive system in which bile cannot physically flow in the proper direction through the tubular biliary tract which causes biliary colic as defined by Rome IV criteria.
Functional causes of biliary pain, also referred to as biliary dyskinesia, are biliary hypokinesia , biliary hyperkinesia and sphincter of Oddi dysfunction (SOD). The exact pathology of functional biliary colic is still unknown. Reviewing Literature status, There is still some debate about the best method to establish the diagnosis gallbladder dyskinesia and hyperkinesia and whether or not ejection fraction is an accurate predictor of outcome. Which led to difficult.
Biliary dyskinesia is identified through gallbladder ejection fraction (GBEF), which is calculated as the flow of radioactive tracer that is ejected from the gallbladder. A GBEF of <35% is considered dyskinesia and a GBEF of <35% is considered hyperkinesia. Patients considered for CCK-HIDA (cholecystokinin hepatobiliary iminodiacetic acid) are those presenting with functional biliary pain based on the Rome IV criteria. Those who present with atypical pain may not need as HIDA (hepatobiliary iminodiacetic acid) as the presentation may be from other pathology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| operative | Experimental | Procedure: cholecystectomy, Drug: Antispasmodic |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 14 years of age
- food-related abdominal pain
- normal gallbladder ultrasound (US)
- GB EF 80% and greater or 35% and less on HIDA scan with CCK injection
Key exclusion criteria (3 listed)
- Patients younger than 14 years old
- Patients with the positive US defined as the presence of gallstones, gallbladder wall thickening (> 4 mm), pericholecystic fluid, sludge, or polyps
- Normal GB EF
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 |
|---|---|---|
| cholecystectomycholecystectomy | Procedure or surgery | operative |
| AntispasmodicAntispasmodic | Drug | operative |
Primary outcome
Rate of quality of life improvment after cholecystectomy according to ROME IV criteria
Time frame: 6 months
abdominal pain, nausea and vomiting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cholecystectomy and Antispasmodic in people with Gall Bladder Pain and Hepatobiliary Iminodiacetic Acid, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Rate of quality of life improvment after cholecystectomy according to ROME IV criteria (time frame: 6 months). 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 20 Oct 2022.