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

Postoperative Complications Clinical Trial

— IGHI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570800
• Other study ID #: VBG-IND-2014-01
• Status: Completed
• Start date: December 2014
• Est. completion date: March 2017

Study information

• Verified date: September 2020
• Source: Castilla-La Mancha Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Liver Failure
• Hepatic Insufficiency
• Indocyanine Green
• Liver Failure
• Liver Failure, Acute
• Postoperative Complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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