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Visceral Steatosis

The study is focused on patients suffering from NASH-induced HCC. Each patient with NASH-related HCC will be paired with 2 patients with non NASH-related HCC (HCV-induced CHC).

HCV-related HCC has been chosen as control population for several reasons: HCV represent a common etiology of HCC; with a distinct pathophysiology distinct from that of post-NASH HCC; populations with post-NASH and post-HCV CHC share similar epidemiological characteristics.

Diagnosis of OSA will be based on the 3% Oxygen Desaturation Index (IDO) obtained by home nocturnal oximetry. The oximetry recordings will be centralized in sleep laboratory of the University Hospital of Grenoble Alpes. Oximetry data will be analyzed by a technician from the sleep laboratory of the University Hospital of Grenoble Alpes

Nocturnal oximetry

Jean-Louis Pépin, MD,PHD

Thomas Decaens, MD,PHD

Obstructive sleep apnea (OSA), one of the most frequent respiratory diseases, could represent a major worsening factor in a non alcoholic steatohepatitis and neoplastic context. Our hypothesis is that OSA promotes the prevalence of HCC related to NASH. This national, multicenter study aims to compare the prevalence of OSA in a group of patient curatively resected for NASH-related HCC with a group of HCV-related HCC.

Obstructive Sleep Apnea (OSA) is a common respiratory disease characterized by the occurrence of recurrent episodes of partial or total obstruction of the upper airway called hypopneas and apneas respectively. These episodes are associated with the repetitive occurrence of the desaturation-reoxygenation sequences, the so-called chronic intermittent hypoxia (IH) which is the major stimulus underlying main cardiovascular, metabolic consequences and pro-inflammatory state found in patients with OSA. Recent data from cohort studies have established that OSA is an even greater risk factor for cancer-related mortality. Hepatocellular carcinoma (HCC) is the second cancer related death worldwide and has an increasing impact in developed countries. The epidemic of metabolic syndrome (MS) plays a growing role in the occurrence of metabolic steatohepatitis (NASH) related HCC. Concerning transition from NASH to NASH-related HCC, neither the frequency nor the underlying mechanism are known. Very recently, a link between OSA (IH) and NASH has been highlighted. OSA and intermittent hypoxia should be a major worsening factor in a neoplastic context. Our hypothesis is that OSA promotes the prevalence of HCC in a context of NASH.

The objective is to compare the prevalence of OSA between patients with NASH-related and hepatitis C virus (HCV)-related HCC. In this type 3, cross-sectional, multicenter, national, non-randomized study patients suffering from a NASH-related or HCV-related hepatocellular carcinoma will be recruited. Investigators expect to show a higher prevalence of OSA in patients with HCC NASH-related but also a shorter overall survival. Complementary ex vivo studies on tumor samples will be conducted in order to explore the mechanisms by which OSA and IH would promote carcinogenesis

Sleep Apnoea Syndrome and Hepatocellular Carcinoma

Evaluation of the Prevalence of Sleep Apnea Syndrome in Patients With Hepatocellular Carcinoma

Number of patient presenting an obstructive apnea syndrome diagnosed by oxymetry

3% IDO represents the number of oxygen desaturation of at least 3% per hour of oxymetry recording, measured by one oximetry measurement during a single night at the patient's home.

2% IDO represents the number of oxygen desaturation of at least 2% per hour of oxymetry recording, measured by one oximetry measurement during a single night at the patient's home.

4% IDO represents the number of oxygen desaturation of at least 4% per hour of oxymetry recording, measured by one oximetry measurement during a single night at the patient's home.

Micro-arousals associated with desaturation will be measured to characterize sleep fragmentation

The time spent with a saturation less than 90 % (Tsat90 in second) to characterize oxygen desaturations and OSA severity

The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality. Consisting of 19 items, the PSQI measures several different aspects of sleep. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

The Epworth sleepiness scale (ESS) is a self-administered questionnaire that's routinely used by doctors to assess daytime sleepiness. The person filling in the questionnaire rates how likely they are to doze off during the day in 8 different situations.The test evaluate the tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing.

Number of patient presenting an obstructive apnea syndrome diagnosed by oxymetry in both subpopulations: cirrhotic and non-cirrhotic.

NAFLD Activity Score includes the degree of steatosis, hepatocyte ballooning, lobular inflammation and fibrosis. Nas score is between 0 and 16.

The Brunt score for NASH patients is used to evaluate fibrosis stage. The score is between 1 and 4.

The METAVIR score is used to evaluate fibrosis stage for HCV patients. The score is between 0 and 4.

Tumor stage evaluated by BCLC classification scale :0,A,B,C and D values (0 for Stage 0 Very early stage, D for terminal stage)

Tumor size (expressed in cm) is asociated to HCC prognostic the size of the tumor is associated with the prognosis of the HCC

The tumor differentiation is classified in 3 levels: low, moderate or high level of tumor differentiation

Presence or absence of tumor vascular invasion

Number of tumoral satellite nodules (multifocality)

Plasma alpha fetoprotein (AFP) level expressed in ng/ml

Overall survival at 1 and 2 years will be collected.

Tumor-free survival at 1 and 2 years will be collected.

Non-recurrence-free survival at 1 and 2 years will be retrospectively or prospectively collected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sleep Apnoea Syndrome and Hepatocellular Carcinoma	NCT04190498	Sleep Apnea, Ob... Hepatocellular ... Non Alcoholic S...	Nocturnal oxime...	18 Years -	University Hospital, Grenoble
Sleep Apnoea Syndrome and Hepatocellular Carcinoma	NCT04190498	Sleep Apnea, Ob... Hepatocellular ... Non Alcoholic S...	Nocturnal oxime...	18 Years -	University Hospital, Grenoble

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