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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCK then Milk | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gallbladder Ejection Fraction | Patient will receive CCK, be scanned, and the ejection fraction will be measured. | 30 minutes after CCK administration |
| 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. | 45 minutes after milk administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Number of Participants Who Received Cholecystectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isis W Gayed, MD | University of Texas Healtlh Science Center at Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24852884 | Background | Edwards MA, Mullenbach B, Chamberlain SM. Pain provocation and low gallbladder ejection fraction with CCK cholescintigraphy are not predictive of chronic acalculous gallbladder disease symptom relief after cholecystectomy. Dig Dis Sci. 2014 Nov;59(11):2773-8. doi: 10.1007/s10620-014-3213-4. Epub 2014 May 23. | |
| 14687804 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | CCK Then Milk | cholecystokinin (CCK) administered and Hepatobiliary imaging (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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gallbladder Ejection Fraction | Patient will receive CCK, be scanned, and the ejection fraction will be measured. | Posted | Mean | Full Range | percentage of ejection of tracer | 30 minutes after CCK administration |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Hepatobiliary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isis Gayed, MD | The University of Texas Health Science Center at Houston | 713-704-1787 | isis.w.gayed@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2016 | Jun 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008892 | Milk |
| D002766 | Cholecystokinin |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
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| CCK | Biological | 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. |
|
|
| 6 months |
| DiBaise JK, Oleynikov D. Does gallbladder ejection fraction predict outcome after cholecystectomy for suspected chronic acalculous gallbladder dysfunction? A systematic review. Am J Gastroenterol. 2003 Dec;98(12):2605-11. doi: 10.1111/j.1572-0241.2003.08772.x. |
| 12883305 | Background | Hadigan C, Fishman SJ, Connolly LP, Treves ST, Nurko S. Stimulation with fatty meal (Lipomul) to assess gallbladder emptying in children with chronic acalculous cholecystitis. J Pediatr Gastroenterol Nutr. 2003 Aug;37(2):178-82. doi: 10.1097/00005176-200308000-00017. |
| 24899960 | Background | Al-Muqbel KM, Bani Hani MN, Elheis MA, Al-Omari MH. Reproducibility of gallbladder ejection fraction measured by Fatty meal cholescintigraphy. Nucl Med Mol Imaging. 2010 Dec;44(4):246-51. doi: 10.1007/s13139-010-0046-8. Epub 2010 Oct 13. |
| 19937405 | Background | Al-Muqbel KM. Gallbladder ejection fraction measured by fatty meal cholescintigraphy: is it affected by extended gallbladder emptying data acquisition time? Ann Nucl Med. 2010 Jan;24(1):29-34. doi: 10.1007/s12149-009-0324-7. Epub 2009 Nov 25. |
| 12869076 | Background | Delgado-Aros S, Cremonini F, Bredenoord AJ, Camilleri M. Systematic review and meta-analysis: does gall-bladder ejection fraction on cholecystokinin cholescintigraphy predict outcome after cholecystectomy in suspected functional biliary pain? Aliment Pharmacol Ther. 2003 Jul 15;18(2):167-74. doi: 10.1046/j.1365-2036.2003.01654.x. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Mean | Full Range | percentage of ejection of tracer | 45 minutes after milk administration |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants Who Received Cholecystectomy | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 2 |
| 50 |
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| D012817 | Signs and Symptoms, Digestive |
| D005502 |
| Food |
| D019602 | Food and Beverages |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |