Aim of thus study is to observe and correlate the course of hepatic blood flow, liver function and liver regeneration after high risk liver surgery.Furthermore we aim to identify ultrasound, liver function and routine hemodynamic parameters…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Portal Venous Blood flow (Ultrasound)
Hepatic Artery Blood flow (Ultrasound)
Hepatic Artery Resistance Index (Ultrasound)
ICG retention after 15 minutes (ICG-R15)
ICG plasma disappearance rate (ICG-PDR)
Maximum Liver Function Capacity by (LiMAx)
Liver remnant volume by (CT Volumetry)
Secondary outcome
Routine laboratory Liver function parameters
Routine Hemodynamic parameters
Clinical Outcomes: length of stay, Ventilator time, ICU readmission, Death
Background summary
In high risk liver surgery patients, unhindered and swift liver regeneration is
paramount to successful outcomes. Recent experimental and clinical studies have
shown that alterations in hepatic blood flow is a driving force of liver
regeneration. Patients with insufficient residual mass or disordered
regeneration have an increased risk of severe postoperative complications
including liver failure and death. However, there is currently no evidence or
guidance how alterations in hepatic blood flow can help clinicians to preserve
liver function and enhance liver regeneration after major liver surgery.
Therefore, we want to observe the course of hepatic blood flow, liver function
and liver regeneration after high risk liver surgery.
Furthermore, we aim to identify parameters or patterns associated with
favourable outcomes such as sufficient liver regeneration and preservation of
liver function after high risk liver surgery. The results of this study will
facilitate identification of opportunities to design future intervention
studies to improve outcomes for high-risk liver surgery patients.
Study objective
Aim of thus study is to observe and correlate the course of hepatic blood flow,
liver function and liver regeneration after high risk liver surgery.
Furthermore we aim to identify ultrasound, liver function and routine
hemodynamic parameters associated with increased liver regeneration after major
liver surgery.
Study design
Prospective observational study with invasive measurements
Study burden and risks
Except the ICG and LiMAx liver function tests and CT-Volumetry scans, there are
no risks associated with participation in this study.
It is known that ICG injection can very exceptionally (<1/10000) cause nausea,
urticarial or an anaphylactoid or anaphylactic reaction. Therefore intravenous
injection will only be performed by -or under direct supervision of- a
physician and will be performed on a hospital ward or ICU.
The LiMAx test uses intravenous injection of 13C-methacetin, a prodrug of
acetaminophen (paracetamol) which will be metabolized to acetaminophen by the
liver. Since intravenous acetaminophen is also routinely used in patients after
high-risk liver surgery, we do not expect an harmful effect of the intravenous
administration of 13C-methacetin.
The CT volumetry scans will give additional radiation exposure. The radiation
exposure has been calculated and presented to the Radiation Exposure Advisory
Board, this evaluation is included in the dossier.
's Gravendijkwal 230
Rotterdam 3015CE
NL
's Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
Major Hepatectomy defined as
- FLR <30% in normal liver
- FLR <40% in diseased liver including post-chemotherapy
Exclusion criteria
< 18 years
Intolerance or allergy to paracetamol or 13C-methacetin
Previous splenectomy
Child C cirrhosis
Concomitant RF/Microwave Ablation
Significant Cardiovascular disease
Pregnancy
No written and signed informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL63662.078.18 |