Clinical trial NCT00685477: Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying
Official title: Dose Response of Intravenous Sincalide (CCK-8) for Gallbladder Emptying
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: CCK infusion
Gallbladder ejection fraction
Normal volunteers
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Penn State University
name: Memorial Health University Medical Center
First posted: 2008-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method
timeFrame: 15, 30, 45, and 60 minutes post drug infusion
Secondary outcomes:
measure: Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method
timeFrame: 15, 30, 45 and 60 minutes post-infusion
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Alan H Maurer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.