Abdominal Pain
Conditions
Brief summary
This study aims to combine the use of IV CCK administration followed by oral milk during a HIDA scan to further stimulate the gallbladder contractility and decrease the number of false abnormal HIDA scans and unnecessary cholecystectomies in some patients.
Detailed description
Hepatobiliary imaging (HIDA) has an important role in the evaluation of the function and dynamics of the hepatobiliary system and the flow of bile to the gastrointestinal system. Contractility of the gallbladder is one of the functions that are uniquely evaluated using a HIDA scan. Poor contractility of the gallbladder can be the source of pain in many patients. Anatomic imaging studies like ultrasound, CT and/or MRI are usually normal in these patients. Contractility of the gallbladder is evaluated during a HIDA scan by intravenous injection of cholecystokinin (CCK) a physiologic peptide enzyme produced in the duodenum in response to the presence of fatty meal which causes the gallbladder to contract and the sphincter of Oddi to relax, thus allowing the flow of bile from the gallbladder to the duodenum. CCK is usually administered during a HIDA scan intravenously after filling of the gallbladder with radioactive tracer to simulate the action of the endogenous CCK in contracting the gallbladder and relaxation of the sphincter of Oddi. Gallbladder ejection fraction (GBEF) in response to CCK injection is calculated using special computer software program. A normal gallbladder ejection fraction is equal to or greater than 35%. Alternative to CCK injection, the patient may be administered milk as a fatty drink that should stimulate a normal gallbladder to contract when it reaches the duodenum approximately 15-20 minutes after oral administration. Thus, gallbladder contractility may be evaluated during a HIDA scan either by injecting CCK intravenously or oral administration of milk. Poor contractility of the gallbladder may result in abdominal pain usually triggered by meals. However, in many patients with abdominal pain and a decreased gallbladder contractility as evaluated by IV CCK or milk may continue to suffer from pain even after surgical removal of the gallbladder . This suggests that abnormally decreased GBEF after CCK or milk stimulation may represent false abnormal finding resulting in unnecessary cholecystectomies in some of the patients. There are no reports in the literature that have used both intravenous CCK stimulation and oral milk administration together in the same patient. This study aims to combine the use of IV CCK administration followed by oral milk during a HIDA scan to further stimulate the gallbladder contractility and decrease the number of false abnormal HIDA scans and unnecessary cholecystectomies in some patients.
Interventions
OTHERMilk
Milk, in the form of 8 oz. half and half, administered after CCK scan, and patient is rescanned and ejection fraction measured to determine if ejection fraction is low.
BIOLOGICALCCK
CCK is standard of care, used in HIDA scans for gallbladder function evaluation. It is given intravenously to cause the gallbladder to contract. The usual dose of CCK is 0.02mg/kg slowly over 3 minutes as per standard.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* All patients referred to a HIDA scan for evaluation of gallbladder function. * No evidence of gallbladder stones on any prior anatomic imaging studies. * Patients who are able to lie flat on the imaging table for an additional 30 min. of imaging after the standard of care 1.5 hour HIDA scan.
Exclusion criteria
* Patients who are under 18 years of age. * Patients with evidence of gallbladder stones on other imaging modalities. * Patient allergic to milk or dairy products. * HIDA scan ordered to evaluate for acute cholecystitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gallbladder Ejection Fraction | 30 minutes after CCK administration | Patient will receive CCK, be scanned, and the ejection fraction will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Abdominal Pain at 6 Months | 6 months | Significant pain scale at follow up was defined as 5 or greater on a scale of 0-10, with 10 being the most severe pain. |
| Number of Participants Who Received Cholecystectomy | 6 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CCK Then Milk CCK administered and HIDA scan performed. Results analyzed, if ejection fraction is low, patient is given milk to drink, and HIDA scan performed again. Results are analyzed to determine if ejection fraction is still low.
CCK: CCK is standard of care, used in HIDA scans for gallbladder function evaluation. It is given intravenously to cause the gallbladder to contract. The usual dose of CCK is 0.02mg/kg slowly over 3 minutes as per standard.
Milk: Milk, in the form of 8 oz. half and half, administered after CCK scan, and patient is rescanned and ejection fraction measured to determine if ejection fraction is low. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | CCK Then Milk |
|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 14.7 |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black | 13 Participants |
| Race/Ethnicity, Customized Other | 14 Participants |
| Race/Ethnicity, Customized White | 19 Participants |
| Region of Enrollment United States | 50 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 2 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Gallbladder Ejection Fraction
Patient will receive CCK, be scanned, and the ejection fraction will be measured.
Time frame: 30 minutes after CCK administration
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CCK Then Milk | Gallbladder Ejection Fraction | 15 percentage of ejection of tracer |
Primary
Gallbladder Ejection Fraction
Patient will receive CCK, be scanned, and the ejection fraction will be measured. Then milk will be administered, repeat scan and ejection fraction will be measured.
Time frame: 45 minutes after milk administration
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CCK Then Milk | Gallbladder Ejection Fraction | 30 percentage of ejection of tracer |
Secondary
Number of Participants Who Received Cholecystectomy
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CCK Then Milk | Number of Participants Who Received Cholecystectomy | 18 Participants |
Secondary
Number of Participants Who Reported Abdominal Pain at 6 Months
Significant pain scale at follow up was defined as 5 or greater on a scale of 0-10, with 10 being the most severe pain.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CCK Then Milk | Number of Participants Who Reported Abdominal Pain at 6 Months | 6 Participants |