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

Not Applicable

• Conditions: Liver Fibroses; Liver Cirrhoses; Squamous Cell Carcinoma of the Head and Neck
• Interventions: Other: Evaluation of the hepatic fibrosis

• Registration Number: NCT03139058
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-03
• Status Verified: 2018-08
• Study Start: 2018-08-20
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
prevalence of cirrhosis	Evaluation of the hepatic fibrosis	Study the prevalence of cirrhosis in patients with VADS cancer

Primary Outcome Measures

Name	Time	Method
Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer	1 day	Determine the prevalence, by registry data analysis, of cirrhosis in patients with VADS cancer

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France