Postoperative Complications Clinical Trial
Official title:
One Way to Diagnose Hepatic Insufficiency the First Postoperative Day After Resection: Prospective Cohort Study
Introduction: Hepatic insufficiency is a complication that puts the life of the patient
undergoing resective surgery at risk. Thus, the diagnosis should be made early. The current
gold standard allows its diagnosis on the fifth postoperative day.
Indocyanine green is a water soluble dye. When administered intravenously, it binds to plasma
proteins and it is removed unchanged by bile, without experiencing enterohepatic
recirculation, which allows estimating the function of hepatocytes and the function of
hepato-splacnic flow. There is a measurement system named "Non-invasive liver function
monitor" (LiMON®, PULSION Medical Systems, Munich, Germany), which allows the measurement of
indocyanine green clearance at the patient's bedside.
Justification: The use of indocyanine green plasma disappearance during the perioperative
period tries to know the exact value of the hepatic function in the most real conditions,
when the excision has been performed, thus giving the investigators the actual value of the
unresected liver. This allows te investigators to estimate the risk of hepatic insufficiency
development that can lead to hepatic failure. Due to the characteristics of the test, it
could get reliable results earlier than the current "gold standard " (50:50 Criteria on the
5th postoperative day).
Hypotheses and Objectives: The investigators hypothesized that the determination of the
hepatic reserve by identifying the indocyanine plasma clearance in real time after hepatic
parenchymal resection could lead to a more accurate and earlier statement of the hepatic
reserve than current tests.
The aim of the study is to determine the usefulness of indocyanine green in the perioperative
period to early diagnosis of hepatic failure.
Materials and Methods: A prospective observational post-authorization study (EPA-SP) is
performed to study de usefulness of indocyanine green. The study was approved by the Ethics
and Clinical Research Committee of the University General Hospital of Ciudad Real. Surgical
patients scheduled for liver surgery, who agreed to be included in the study and signed an
informed consent, were included in the study over a two-year period, after having understood
the study objectives and its possible complications.
Measurements were performed with the LiMON® monitor prior to liver resection and on the first
postoperative day to patients undergoing liver resection surgery and compared with gold
standard.
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