Phase 4
N=50
Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively
Abdominal Pain
Bottom Line
View on ClinicalTrials.gov: NCT02748525 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Gallbladder Ejection Fraction — 15 percentage of ejection of tracer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Milk (Other); CCK (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gallbladder Ejection Fraction |
30 | — |
| PRIMARY Gallbladder Ejection Fraction |
30 | — |
| SECONDARY Number of Participants Who Reported Abdominal Pain at 6 Months |
6 | — |
| SECONDARY Number of Participants Who Received Cholecystectomy |
18 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02748525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.