DRUG
Experimental Sequence ABC
Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes
Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying
Status
Completed
Phase
Not applicable
Enrollment
60
Locations
1
Results
Posted
Publications
2
Study summary
What the protocol is testing.
This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
Full detailed description
This study enrolled 60 healthy volunteers from four institutions (Johns Hopkins University, Pennsylvania State University, Memorial Health University Medical Center, and Temple University. Subjects had to be healthy men or women 18-65 years old with no gastrointestinal disease as confirmed by initial screening using a modified Mayo Clinic Research Gastrointestinal Disease Screening Questionnaire, and normal results for CBC, metabolic profile, serum amylase and gallbladder ultrasonography. Women could not be enrolled if pregnant. Subjects had 3 infusion studies at least 2 days apart within 3 weeks.
Interventions
Treatment arms and agents.
DRUG
Experimental Sequence ACB
Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes
DRUG
Experimental Sequence BAC
Drug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion
DRUG
Experimental Sequence BCA
Drug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion
DRUG
Experimental Sequence CAB
Drug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion
DRUG
Experimental Sequence CBA
Drug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion
Timeline
From registration to results.
First posted
May 28, 2008
Study start
May 2008
Primary completion
May 2009
Study completion
Jul 2009
Results posted
Feb 17, 2017
Registry updated
Feb 17, 2017
Outcomes
What the study measures.
Primary outcomes
Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method
Time frame · 15, 30, 45, and 60 minutes post drug infusion
The primary statistical endpoint was the CV as a measure of variability for the GBEF for each infusion method at the different intervals to determine which sincalide infusion method had the lowest variation. The CV is the SD divided by the mean and is expressed as a percentage and reflects the variability among the values. The infusion method having the lowest CV is considered best as it reflects the lowest variability of the values.
Secondary outcomes
Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method
Time frame · 15, 30, 45 and 60 minutes post-infusion
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Healthy males and females between ages 18-65 years of age with no gastrointestinal disease as screened by the Mayo Clinic GI Disease Screening Questionnaire 2. Subjects with high probability for compliance and completion of the study 3. Normal liver function tests and amylase 4. Normal ultrasound of the gallbladder Exclusion Criteria: 1. Prior GI surgery, excluding appendectomy 2. Surgery within the past 3 months 3. BMI \> 35 4. Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test) 5. Cardiovascular, endocrine, renal, gastrointestinal, or other chronic disease likely to affect motility. This includes diabetes, renal insufficiency, gastroesophageal reflux disease, gastroparesis, irritable bowel syndrome, prior peptic ulcer disease. 6. GI symptoms such as heartburn, chest pain, dysphagia, abdominal pain, nausea, vomiting, constipation, diarrhea.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Temple University Hospital
Philadelphia, Pennsylvania, United States
Publications
Results and literature.
PMID 16678563 ↗Behar J, Corazziari E, Guelrud M, Hogan W, Sherman S, Toouli J. Functional gallbladder and sphincter of oddi disorders. Gastroenterology. 2006 Apr;130(5):1498-509. doi: 10.1053/j.gastro.2005.11.063.PMID 20080900 ↗Ziessman HA, Tulchinsky M, Lavely WC, Gaughan JP, Allen TW, Maru A, Parkman HP, Maurer AH. Sincalide-stimulated cholescintigraphy: a multicenter investigation to determine optimal infusion methodology and gallbladder ejection fraction normal values. J Nucl Med. 2010 Feb;51(2):277-81. doi: 10.2967/jnumed.109.069393. Epub 2010 Jan 15.
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