Clinical trial NCT02748525: Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively
Official title: Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Pain
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Gallbladder Ejection Fraction
timeFrame: 30 minutes after CCK administration
measure: Gallbladder Ejection Fraction
timeFrame: 45 minutes after milk administration
Secondary outcomes:
measure: Number of Participants Who Reported Abdominal Pain at 6 Months
timeFrame: 6 months
measure: Number of Participants Who Received Cholecystectomy
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center Houston
state: Texas
Study officials:
affiliation: University of Texas Healtlh Science Center at Houston
name: Isis W Gayed, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.