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Clinical Validation of a Raman Spectroscope to Determine Hepatic Fat Content

NCT02621853 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-08-26

No results posted yet for this study

Summary

Fatty liver disease including liver steatosis (fat deposition) is a major health problem worldwide. It is considered pathological when fat accumulation exceeds 5% of the liver weight. Transplantation represents the ultimate treatment for end stage liver disease. However, the discrepancy between the demand for donor organs and their availability presents one of the greatest hurdles of liver transplantation. Therefore, extended criteria organs have to be considered to overcome this shortcoming. Hepatic steatosis is one of the most important criteria defining extended-criteria donor liver. In liver transplantation, 'severe' fat deposition in donor liver is a major cause of graft failure while 'mild' deposition is considered transplantable and 'moderate' deposition represents the gray zone and remains difficult to assess. Surgeons usually perform a hepatic steatosis assessment during liver donor surgery. However, this method is very subjective and difficult especially when inexperienced surgeons or trainees are concerned. Furthermore, it has recently been documented that the assessment of steatosis is challenging even in the hands of experienced surgeons. Theoretically, a better way to assess steatosis before organ procurement would be a non-invasive imaging technique. However, some of these techniques appear to lack the sensitivity to accurately quantify hepatic fat content while others are complex, expensive and inconvenient to use in the setting of organ procurement. Therefore, liver biopsy remains the reference for grading hepatic steatosis. In daily practice the assessment and quantification of steatosis by a pathologist during organ procurement is more complex related to the lack of availability of dedicated hepatopathologists outside of office hours and in smaller community hospitals. A simple and short technique is therefore required to assess liver steatosis before retrieval. We have recently demonstrated that Raman spectroscopy could provide an accurate, rapid and real-time assessment of hepatic fat content and correlated highly with the gold standard (i.e. histopathological assessment of liver sections) in an animal model of liver steatosis. The purpose of this study is to validate the use of Raman spectroscopy for quantitative assessment of hepatic steatosis. In the hands of the surgeons this device can provide an immediate, robust tool to assess the suitability of donor livers at the site of retrieval prior to liver transplantation.

Conditions

  • Steatosis

Interventions

DEVICE

Raman spectroscopy of the liver

Liver will be illuminated by the Raman spectroscope optic probe in order to assess fat content

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Ian Alwayn, MD · Dalhousie University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-15
Primary Completion
2016-03-10
Completion
2017-03-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02621853 on ClinicalTrials.gov