Prevalence of Liver Fibrosis and Cirrhosis in Patients With Squamous Cell Carcinoma of the Head and Neck (fibr'HOM)

Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS).

Study Overview

• Status: Unknown
• Conditions: Squamous Cell Carcinoma of the Head and Neck; Liver Cirrhoses; Liver Fibroses
• Intervention / Treatment: Other: Evaluation of the hepatic fibrosis

Detailed Description

Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS). Among patients with VADS cancer, more than 60% reported daily alcohol consumption of more than 20 g / d. Such poisoning can be harmful, causing histological lesions of alcoholic liver disease, such as steatosis, alcoholic hepatitis, liver fibrosis and cirrhosis. In a population consuming more than 50 g of alcohol per day for 5 years, the prevalence of severe hepatic fibrosis is between 30% and 40%. In the therapeutic management of a cancer of VADS, the presence of cirrhosis is a prognostic element, increasing the postoperative risk of haemorrhage, surgical site infection and acute renal failure. The search for cirrhosis in the pre-therapeutic assessment is therefore important. The diagnosis of cirrhosis is not a problem when clinical, biological, radiological or endoscopic signs of hepatic insufficiency or portal hypertension are present. Asymptomatic cirrhosis is more difficult to diagnose without liver biopsy. Noninvasive hepatic exploration techniques have recently been developed and validated for the evaluation of liver fibrosis in the context of alcoholic liver disease. Fibroscan® (Echosens, Paris, France) is an imaging device for measuring the liver hardness (hepatic elasticity expressed in kPa), with a strong correlation with the presence of histological fibrosis of the liver. At the threshold of 19.5 kPa, Fibroscan can be used to diagnose cirrhosis with good diagnostic performance (Se 80%, Sp 90%, VPP 93%, VPN 70%) and good inter- and intra-observer reproducibility. Elastometry is a simple, reliable and non-invasive tool to systematically evaluate hepatic fibrosis in patients with VADS cancer. The examination can be performed during a routine care consultation. The post-therapeutic morbidity induced by cirrhosis in the cancers of VADS is not well known and there is no recommendation in France about the hepatic explorations to be carried out during the initial assessment of these neoplasias. It is essential to be able to specify this morbidity in order to adapt if necessary the therapeutic strategy of cancers of VADS.

The objective of this study is to systematically determine the presence of cirrhosis and / or liver fibrosis in patients with VADS cancer, in order to investigate their impact on the morbidity after treatment of squamous cell carcinomas of the head and neck.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cyril PAGE, PhD; Phone Number: +33322668623; Email: page.cyril@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • CHU Amiens Picardie
      • Contact: Cyril PAGE, PhD; Phone Number: +33322668623; Email: page.cyril@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient over 18 years of age
• Supported in the department of Orl & CCF or Maxillo-Faciale surgery of the CHU d'Amiens

• Histological diagnosis of epidermoid carcinoma:

  • From the oral cavity
  • From the oropharynx
  • Hypopharynx
  • Larynx
• Any stage of cancer
• Affiliation to a social security scheme

Exclusion Criteria:

• Patient already treated previously for a cancer of the VADS
• Patient referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: prevalence of cirrhosis; Study the prevalence of cirrhosis in patients with VADS cancer	Other: Evaluation of the hepatic fibrosis; Evaluation of the hepatic fibrosis stage by a hepatological assessment (Clinical, biological and imaging)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer	Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Cyril PAGE, PhD, CHU Amiens Picardie

Study record dates

Study Major Dates

• Study Start (Anticipated): August 20, 2018
• Primary Completion (Anticipated): June 20, 2019
• Study Completion (Anticipated): June 20, 2019

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Liver Diseases; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Fibrosis; Carcinoma; Liver Cirrhosis; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: PI2016_843_0034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No