One Way to Diagnose Hepatic Insufficiency the First Postoperative Day After Resection: Prospective Cohort Study (IGHI)

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Acute Liver Failure; Indocyanine Green

• Study Type: Observational
• Enrollment (Actual): 44

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Surgical patients scheduled for liver surgery, who agreed to be included in the study and signed the informed consent given to them following information given about the aims of the study and its possible complications, were included in the study consecutively for a period of two years

Description

Inclusion Criteria:

• Patients susceptible of receiving Surgical treatment
• Liver Disease with Surgical Indication
• Adulthood
• Accept Inclusion

Exclusion Criteria:

• History of Hypersensitivity to Indocyanine Green or Iodine
• Thyroid Pathology
• Underage Status
• Pregnant
• Irresectable Tumors

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients wich the plasma removal rate of Indocianin Green at 24h of surgery correlates with the existence of liver failure on the 5th postoperative day	Number of patients wich the plasma removal rate of Indocianin Green at 24h of surgery correlates with the existence of liver failure on the 5th postoperative day	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients wich the plasma removal rate of Indocianin Green at 24h of surgery correlates with the existence of liver failure on the 3th postoperative day	Number of patients the plasma removal rate of Indocianin Green at 24h of surgery correlates with the existence of liver failure on the 3th postoperative day	3 days

Collaborators and Investigators

• Sponsor: Castilla-La Mancha Health Service

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Indocyanine green; LIMON; Postoperative liver failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Liver Failure; Hepatic Insufficiency; Postoperative Complications; Liver Failure, Acute
• Other Study ID Numbers: VBG-IND-2014-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No