NCT02748525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

May 3, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 2, 2019

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

2.1 years

First QC Date

April 4, 2016

Results QC Date

June 13, 2019

Last Update Submit

June 13, 2019

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Number of Participants Who Reported Abdominal Pain at 6 Months

    6 months

  • Number of Participants Who Received Cholecystectomy

    6 months

Study Arms (1)

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.

Other: MilkBiological: CCK

Interventions

MilkOTHER

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.

CCK then Milk
CCKBIOLOGICAL

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.

Also known as: Cholecystokinin
CCK then Milk

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center Houston

Houston, Texas, 77030, United States

Location

Related Publications (6)

  • 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.

    PMID: 24852884BACKGROUND

  • 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.

    PMID: 14687804BACKGROUND

  • 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.

    PMID: 12883305BACKGROUND

  • 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.

    PMID: 24899960BACKGROUND

  • 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.

    PMID: 19937405BACKGROUND

  • 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.

    PMID: 12869076BACKGROUND

MeSH Terms

Conditions

Abdominal Pain

Interventions

MilkCholecystokinin

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Isis Gayed, MD
Organization
The University of Texas Health Science Center at Houston
isis.w.gayed@uth.tmc.edu
713-704-1787

Study Officials

  • Isis W Gayed, MD

    University of Texas Healtlh Science Center at Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiology - Clinical

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 22, 2016

Study Start

May 3, 2016

Primary Completion

June 14, 2018

Study Completion

June 14, 2018

Last Updated

July 2, 2019

Results First Posted

July 2, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)