Clinical Validation of a Raman Spectroscope to Determine Hepatic Fat Content

NCT02621853 | Terminated DMC

• 1 other identifier: 002
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Steatosis

Outcome Measures

Primary Outcomes (1)

• Grade of steatosis determined according to the international standards by histopathological assessment of the liver biopsy specimen

  12 months

Study Arms (1)

MRI+RAMAN

OTHER

Patients will undergo an MRI for assessment of the fat content of the liver. Then during surgery, their livers will be illuminated (for a few seconds) by Raman spectroscope (the device in question) to see if MRI findings correlate well with Raman spectroscopy findings.

Device: Raman spectroscopy of the liver

Interventions

Raman spectroscopy of the liver DEVICE

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

MRI+RAMAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years of age), female/male patients who will undergo an open partial liver resection surgery in our institution will be included

You may not qualify if:

• Patients who are scheduled for a metastasectomy or wedge resection where the margin of normal liver that is expected to be removed is less than 1 cm will be excluded.
• In addition, patients who have the following will be excluded:
• Visual and/or mental impairment
• Coagulation disorder
• Cardiac pacemaker and/or defibrillator
• Deep brain stimulator
• Bullets or gunshot pellets
• Cerebral aneurysm clips
• Cochlear implant
• Magnetic dental implants
• Drug infusion devices

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Related Publications (23)

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MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Ian Alwayn, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 4, 2015
• Study Start: December 15, 2015
• Primary Completion: March 10, 2016
• Study Completion: March 10, 2017
• Last Updated: August 26, 2024

Record last verified: 2022-10