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

NCT ID: NCT04570800

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-03-31

Brief 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.

Conditions

Indocyanine Green; Postoperative Complications; Acute Liver Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Castilla-La Mancha Health Service

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

VBG-IND-2014-01

Identifier Type: -

Identifier Source: org_study_id