Hepatic Ischemia-reperfusion Injury Clinical Trial
Official title:
In Situ Hypothermic Perfusion During Right Hemihepatectomy
Rationale
Currently, hepatic resection is often the only curative treatment for primary or secondary
hepatic malignancies and is also frequently performed in patients with benign liver tumors
to prevent malignant transformation and/or alleviate symptoms. Liver resections are nowadays
associated with low mortality and acceptable morbidity. As result of that, an increasing
number of patients is currently under consideration for resection of more complex or large
tumors, thus requiring extensive resection procedures. Application of vascular exclusion
(i.e., clamping of the portal vein and hepatic artery) during such procedures reduces blood
loss, which is one of the most important factors affecting peri-operative outcomes. However,
vascular exclusion leads to ischemia-reperfusion (I/R) injury as an inevitable side-effect,
which adversely impacts postoperative liver function and regeneration. Additional cooling of
the liver by means of hypothermic perfusion is expected to further reduce intraoperative
blood loss, as well as to protect the liver from I/R injury. Therefore, the aim of this
pilot study is to cool the future remnant liver (FRL) in situ during right hemihepatectomy
under vascular exclusion. Consequently, an overall improvement in postoperative outcomes is
expected due to a decrease in intraoperative blood loss, reduced parenchymal damage, and a
better ability of the liver remnant to regenerate.
Objective
To reduce intraoperative blood loss and enhance tolerance of the FRL to I/R injury during
right hemihepatectomy under vascular exclusion by means of in situ hypothermic perfusion
with retrograde outflow (R-IHP) of the FRL.
Study design
The study is designed as a prospective randomized pilot study in 18 patients (9
interventions and 9 controls) to assess the effects of the proposed intervention.
Additionally, 4 patients will be included separately for assessment of the intervention's
feasibility prior to randomized inclusion.
Study population
Eligible patients for participation in this study are those planned to undergo right
hemihepatectomy under vascular inflow occlusion because of a malignant or benign liver
tumor, and who do not suffer from any hepatic co-morbidity that might influence
postoperative outcomes (i.e., severe steatosis, cholestasis, cirrhosis, or hepatitis B/C
infection).
Intervention
During right hemihepatectomy, the FRL of patients allocated to the intervention group will
be perfused with a chilled perfusion solution (i.e., lactated Ringer's solution).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment