Quantification of postoperative change of liver function (measured with hepatobiliary scintigraphy). This change will be correlated with liver regeneration by measuring circulating regeneration-related biomarkers at different timepoints…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlations between the changes in liver function (as measured with
hepatobiliary scintigraphy) at day of admission versus postoperative day 5 and
the concomitant changes in circulating regeneration biomarkers
Secondary outcome
Variability of liver function whithin a patient.
Correlation between postoperative changes in liver stiffness and changes in
liver function (as measured with hepatobiliary scintigraphy) at day of
admission versus postoperative day 5
Background summary
Posthepatectomy liver failure (PHLF) is the most severe complication that can
occur after major liver resection with an incidence between 7% in patients with
healthy parenchyma and reaching 30% in patients with liver cirrhosis. The
current management is mostly supportive and PHLF has a mortality rate of over
80%.
After hepatectomy, the remaining hepatocytes undergo regeneration which is a
crucial step for the liver to uphold its function. When this is insufficient,
due to decreased functional mass, PHLF develops.
In order to minimize the risk of PHLF, pre-operative assessment of liver
function is undertaken with the use of liver function test. Hepatobiliary
scintigraphy (HBS) is a validated quantitative dynamic liver function test that
is able to calculate the global and regional liver function.
Another tool to assess the quality of liver parenchyma is liver stiffness
measurement (LSM).Transient elastography (TE) is a non-invasive
ultrasound-based method that measure tissue stiffness. Liver elasticity is
correlated with grade of fibrosis, parenchymal inflammation and bile outflow
obstruction.
So far, no studies have been conducted that assess the postoperative change in
liver function in relation to liver regeneration. Evaluating the role of
biomarkers in postoperative liver function can provide new insights in the
regeneration physiology, potentially leading to new monitoring tools or
therapeutic strategies aimed at preventing or treating PHLF. Furthermore, the
change in liver stiffness after liver resection and it*s correlation with
regeneration, inflammation and other complications remains unanswered.
Perioperative measurements of liver stiffness could provide useful means for
assessing the physiology of liver regeneration and might provide an easy
accessible, cheap and non-invasive bed-side monitoring tool for postoperative
patients.
Study objective
Quantification of postoperative change of liver function (measured with
hepatobiliary scintigraphy). This change will be correlated with liver
regeneration by measuring circulating regeneration-related biomarkers at
different timepoints postoperatively. Furthermore, to correlate postoperative
tissue elasticity with these biomarkers and change in liver function.
Study design
Prospective observational pilot study
Study burden and risks
Participating in this study leads to no advantage for the individual patient.
The burden for the patient is three additional HBS-scans outside of standard
practice, this scan takes 30-45 minutes and has a radiation burden ranging
between 5.1-6.8 mSv per scan. HBS is safe and part of standard work-up and
entails minimal risk to the patient. The time burden is 30-45 minutes per scan.
Furthermore, three LSM will be performed at bedside or outpatient clinic, this
has no radiation burden, is painless and non-invasive. The time investment is
approximately 5-10 minutes per time. Lastly, blood drawings consist of 3 extra
tubes (in total 15.7 mL) per time-point. There will be no extra blood drawing
moments outside of standard practice. No additional site visits outside of
standard practice are required for this study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Major liver resection (3 or more Couinaud segments)
Written informed consent
>= 18 years old
Exclusion criteria
Serum bilirubine > 50 µmol/L
'Two-stage' procedures
ALPPS procedure
Allergy for mebrofenin
Pregnant
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL63868.018.17 |
OMON | NL-OMON22009 |