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Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively (Milk)

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ClinicalTrials.gov Identifier: NCT02748525
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Isis W Gayed, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Abdominal Pain Other: Milk Biological: CCK Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively
Actual Study Start Date : May 3, 2016
Actual Primary Completion Date : June 14, 2018
Actual Study Completion Date : June 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arm Intervention/treatment
Experimental: 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.
Other: 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.

Biological: 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.
Other Name: Cholecystokinin




Primary Outcome Measures :
  1. Change in ejection fraction from original [ Time Frame: 45 minutes after CCK administration, 45 minutes after milk administration ]
    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 :
  1. Number of participants who reported abdominal pain at 6 months [ Time Frame: 6 months ]
  2. Number of patients who received cholecystectomy [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748525


Locations
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United States, Texas
University of Texas Health Science Center Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Isis W Gayed, MD University of Texas Healtlh Science Center at Houston

Publications:

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Responsible Party: Isis W Gayed, Associate Professor of Radiology - Clinical, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02748525     History of Changes
Other Study ID Numbers: HSC-MS-16-0015
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient data will be collected, deidentified, and collated into aggregate. Descriptive statistics will be used to describe outcome.

Additional relevant MeSH terms:
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Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Cholecystokinin
Cholagogues and Choleretics
Gastrointestinal Agents