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van CCT (UK)

van CCT (UK)

Liver function stress test - Chocolate stress test

- candidate number27497
- NTR NumberNTR6613
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jul-2017
- Secondary IDsNL51764.018.14 CCMO
- Public TitleLiver function stress test - Chocolate stress test
- Scientific Title99mTc-mebrofenin Hepatobiliary Scintigraphy (99mTc-HBS) liver function stress test - liver reserve capacity and age dependant changes in liver function
- ACRONYMChocolate stress test
- hypothesisWe expect to demonstrate an increase in total liver function after stimulation with a fatty food challenge in comparison with fasting state; liver functional reserve capacity.
We expect younger individuals to differ in total liver function and functional reserve capacity compared to the elderly (≥75 years)
- Healt Condition(s) or Problem(s) studiedLiver function, Hepatobiliary scintigraphy
- Inclusion criteriaAge between 50-60 or ≥75 years
No known hepatic disease
No previous hepatic procedures
No previous chemotherapy treatment
No known allergies/intolerance for the administered challenge agent (full fat chocolate milk)
Signed informed consent obtained prior to any study-specific procedures
- Exclusion criteriaAge < 50 or between 61-74 years
Known with hepatic disease
Underwent hepatic procedures in the past
Treated with chemotherapy in the past
Allergies/intolerance for the challenge agent (full fat chocolate milk)
Pregnancy or breastfeeding
Not able to sign informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 27-jan-2015
- planned closingdate31-aug-2018
- Target number of participants24
- InterventionsSubjects will undergo HBS twice during 2 visits. For the second HBS-scan, 250 mL full fat chocolate milk will be administered to the participating subjects 30 minutes prior to the scan.
- Primary outcomeChange in total liver function after ingestion of the challenge agent in comparison with the initial liver function, expressed as absolute value (%/min/m2) and percentage of initial liver function.
- Secondary outcomeDifference in initial total liver function between younger and elderly subjects (%/min/m2).
Difference in change of total liver function after ingestion of the challenge agent between younger and elderly subjects (%/min/m2).
- Timepoints12 patients between 50-60 years old
12 patients ≥75 years old
We hope to have included all 24 patients before the end of 2017
- Trial web site
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESProf. dr. T.M. Gulik, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- Publications
- Brief summarySurgical resection remains the only curative treatment for primary or secondary liver tumors. Preoperative evaluation of the future remnant liver (FRL) is important in the assessment of patients undergoing major liver resection. Liver resection performed in absence of a sufficient FRL can lead to post-hepatectomy liver failure, a severe life-threatening complication.

99mTc-mebrofenin hepatobiliary scintigraphy (HBS) is a quantitative liver function test and is used to assess total liver function (TLF) in patients scheduled for major liver resection

Normally, HBS is performed after a 4 hours fast. The hepatocytes are presumably in a resting state which might reflect the resting liver function. It is presumable that the liver has a reserve capacity during stimulation. Knowledge of the stimulated liver function could be of interest for optimal patient selection, especially patients with borderline FRL function, since TLF might be underestimated in fasting patients.

We aim to explore changes in the TLF, expressed in mebrofenin uptake rate (%/min/m2) after stimulation with a fatty food challenge prior to HBS.
- Main changes (audit trail)
- RECORD4-jul-2017 - 13-aug-2017

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