Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively (Milk)
Primary Purpose
Abdominal Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Milk
CCK
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Pain
Eligibility Criteria
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.
Sites / Locations
- University of Texas Health Science Center Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CCK then Milk
Arm Description
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.
Outcomes
Primary Outcome Measures
Gallbladder Ejection Fraction
Patient will receive CCK, be scanned, and the ejection fraction will be measured.
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.
Secondary Outcome Measures
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.
Number of Participants Who Received Cholecystectomy
Full Information
NCT ID
NCT02748525
First Posted
April 4, 2016
Last Updated
June 13, 2019
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT02748525
Brief Title
Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively
Acronym
Milk
Official Title
Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 3, 2016 (Actual)
Primary Completion Date
June 14, 2018 (Actual)
Study Completion Date
June 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CCK then Milk
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Milk
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
CCK
Other Intervention Name(s)
Cholecystokinin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gallbladder Ejection Fraction
Description
Patient will receive CCK, be scanned, and the ejection fraction will be measured.
Time Frame
30 minutes after CCK administration
Title
Gallbladder Ejection Fraction
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants Who Reported Abdominal Pain at 6 Months
Description
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
Title
Number of Participants Who Received Cholecystectomy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isis W Gayed, MD
Organizational Affiliation
University of Texas Healtlh Science Center at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24852884
Citation
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.
Results Reference
background
PubMed Identifier
14687804
Citation
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.
Results Reference
background
PubMed Identifier
12883305
Citation
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.
Results Reference
background
PubMed Identifier
24899960
Citation
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.
Results Reference
background
PubMed Identifier
19937405
Citation
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.
Results Reference
background
PubMed Identifier
12869076
Citation
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.
Results Reference
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Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively
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