To demonstrate completeness of occlusion of the segmental portal branches after unilateral PVE by intraoperative portography. A secondary aim is to assess the perfusion of the liver after PVE on microvascular level by O2C and ICG clearance; and to…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is defined as the effect of PVE on portal venous perfusion
of the liver.
Secondary outcome
Secondary study parameters/endpoints are:
* the parameters obtained using the O2C technique;
* the hepatic I/R injury after vascular clamping;
* the perfusion of the liver on microvascular level; and
* liver regeneration after PVE and surgery.
Background summary
Surgical resection is the most effective treatment for primary or secondary
hepatic tumors. Portal vein embolization (PVE) was introduced to enable more
extensive liver resections by inducing compensatory hypertrophy of the
non-embolised, future remnant liver (FRL). This hypertrophy response can be
measured by plasma bile acids, triglycerides and ApoA-V. Preoperative imaging
is necessary to determine not only the increase in volume and function of the
FRL (using CT-volumetry and HBS SPECT) but also to assess the complex perfusion
pattern of the portal system. Portography gives a detailed view of the portal
vascular system of the liver and provides additional preoperative information
on the efficacy of portal venous occlusion. In hepatic surgery continuous or
intermittent clamping (Pringle manoeuvre) of the hepatic artery and portal vein
is frequently applied to reduce intra-operative blood loss. This Pringle
manoeuvre results in warm ischemia-reperfusion injury of the liver. Perfusion
of the embolized and non-embolized parts of the liver are assessed on the
microvascular level using laser Doppler flowmetry and tissue spectrophotometry
(O2C) and the ICG (Indocyanine Green) clearance test.
Study objective
To demonstrate completeness of occlusion of the segmental portal branches after
unilateral PVE by intraoperative portography. A secondary aim is to assess the
perfusion of the liver after PVE on microvascular level by O2C and ICG
clearance; and to investigate liver regeneration after PVE and hepatic
resection by assessment of plasma bile acids, triglycerides and ApoA-V.
Study design
The study is designed as a prospective, single centre trial.
Study burden and risks
The risks associated with the contrast injection and X-rays of the portography
are very small, as we use low amounts of contrast and radiation. The only
intervention will be portography by direct injection of the portal vein after
laparotomy. The O2C- and ICG- measurements carry no extra risk for the patient.
There is a possibility of bleeding after the biopsies of the liver, but this
procedure is carried out under direct vision and any bleeding site is
immediately controlled. Additional blood tests will be performed without any
risk for the patient.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. Patient is planned for elective liver resection or PVE is performed, and patient will
undergo hepatic surgery within 3-6 weeks after PVE
2. Age * 18 years
3. Signed written informed consent obtained prior to any study-specific procedure
4. ASA classification I * IV
Exclusion criteria
1. Age < 18 years
2. ASA classification V
3. Patient has a traumatic liver
4. Emergency operations
5. Pregnancy
6. Breast feeding period
7. Informed consent missing
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 | NL31512.018.10 |