Trial Outcomes & Findings for Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively (NCT NCT02748525)

Results Overview

Patient will receive CCK, be scanned, and the ejection fraction will be measured.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

30 minutes after CCK administration

Results posted on

2019-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	CCK Then Milk cholecystokinin (CCK) administered and Hepatobiliary imaging (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. 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. 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.
Overall Study STARTED	50
Overall Study Completed Study Intervention	50
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Gallbladder Contractility Using Both CCK and Milk Consecutively

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CCK Then Milk n=50 Participants 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. 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. 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.
Age, Continuous	48.6 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants
Race/Ethnicity, Customized Black	13 Participants n=5 Participants
Race/Ethnicity, Customized White	19 Participants n=5 Participants
Race/Ethnicity, Customized Other	14 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes after CCK administration

Patient will receive CCK, be scanned, and the ejection fraction will be measured.

Outcome measures

Outcome measures
Measure	CCK Then Milk n=50 Participants 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. 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. 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.
Gallbladder Ejection Fraction	15 percentage of ejection of tracer Interval 0.0 to 33.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CCK Then Milk n=50 Participants 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. 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. 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.
Gallbladder Ejection Fraction	30 percentage of ejection of tracer Interval 2.0 to 88.0

SECONDARY outcome

Timeframe: 6 months

Significant pain scale at follow up was defined as 5 or greater on a scale of 0-10, with 10 being the most severe pain.

Outcome measures

Outcome measures
Measure	CCK Then Milk n=39 Participants 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. 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. 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.
Number of Participants Who Reported Abdominal Pain at 6 Months	6 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	CCK Then Milk n=39 Participants 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. 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. 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.
Number of Participants Who Received Cholecystectomy	18 Participants

Adverse Events

CCK Then Milk

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CCK Then Milk n=50 participants at risk 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. 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. 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.
Hepatobiliary disorders Abdominal Pain	4.0% 2/50 • Number of events 2 • 6 months

Additional Information

Isis Gayed, MD

The University of Texas Health Science Center at Houston

Phone: 713-704-1787

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place