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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 : Recruiting
First Posted : April 22, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Isis W Gayed, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE April 4, 2016
First Posted Date  ICMJE April 22, 2016
Last Update Posted Date November 17, 2017
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02748525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2016)
  • Number of participants who reported abdominal pain at 6 months [ Time Frame: 6 months ]
  • Number of patients who received cholecystectomy [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively
Official Title  ICMJE Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively
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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Abdominal Pain
Intervention  ICMJE
  • 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
Study Arms 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.
Interventions:
  • Other: Milk
  • Biological: CCK
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date March 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Isis W Gayed, MD 713-704-1787 isis.w.gayed@uth.tmc.edu
Contact: Karen P Swaby, BSN 713-704-2842 karen.p.swaby@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02748525
Other Study ID Numbers  ICMJE HSC-MS-16-0015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Isis W Gayed, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Isis W Gayed, MD University of Texas Healtlh Science Center at Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP