Prevalence of Liver Fibrosis and Cirrhosis in Patients With Squamous Cell Carcinoma of the Head and Neck

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

— fibr'HOM  

Official title:

Prevalence of Liver Fibrosis and Cirrhosis in Patients With Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03139058
• Other study ID #: PI2016_843_0034
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: June 20, 2019

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Cyril PAGE, PhD
• Phone: +33322668623
• Email: page.cyril[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 20, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Fibrosis
• Head and Neck Neoplasms
• Liver Cirrhoses
• Liver Cirrhosis
• Liver Fibroses
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Other:
• Evaluation of the hepatic fibrosis
Evaluation of the hepatic fibrosis stage by a hepatological assessment (Clinical, biological and imaging)

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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