Using Infrared Spectroscopy for Diagnosis Severity of Nonalcoholic Fatty Liver Disease

Completed

• Conditions: Non-alcoholic Fatty Liver Disease; Fatty Liver
• Interventions: Procedure: liver biopsy; Other: infrared spectroscopy

• Registration Number: NCT02860884
• Lead Sponsor: Rennes University Hospital

Brief Summary

The main objective of this study is to evaluate the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-04
• Study Completion: 2015-10
• Status Verified: 2016-07
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-08-04
• Last Update Submitted: 2016-08-04
• Study First Posted: 2016-08-09
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Patients who have undergone a liver biopsy for simple fatty liver or NASH and for which a serum sample is serum bank
• Men or Women
• aged of 18 years or more
• After giving their consent to participate in research

Exclusion Criteria

• Known Cancer
• Refusal of consent
• Inflammatory disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NASH	liver biopsy	patients with nonalcoholic steatohepatitis
simple fatty liver	infrared spectroscopy	patients with fatty liver disease
simple fatty liver	liver biopsy	patients with fatty liver disease
NASH	infrared spectroscopy	patients with nonalcoholic steatohepatitis

Primary Outcome Measures

Name	Time	Method
Sensitivity	through study completion, an average of 1 year	Evaluation of the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH with liver biopsy as a gold standard

Trial Locations

Locations (1)

Centre hospitalier universitaire de Rennes; 🇫🇷 Rennes, France