Evaluation of the Prevalence of Sleep Apnea Syndrome in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The study will compare OSA prevalence in a group of patient curatively resected for NASH-related HCC with a group of HCV-related HCC.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man and woman
- •>18 years
- •Diagnosis of NASH-induced HCC or HCV-induced HCC
- •Patients treated by surgical excision
- •Patients not opposed to the study
排除标准
- •Patient refusal
- •Alcohol consumption> 20g / day for women and> 30g / day for men
- •Patient with HCV genotype 3
- •Tumor vascular invasion identified preoperatively
- •Other etiologies of hepatopathies (alcoholic, viral B, autoimmune, hemochromatosis)
- •Other chronic respiratory diseases: chronic obstructive pulmonary disease, respiratory insufficiency
- •Patient weight variation >5% since surgical treatment of his HCC
- •Subject deprived of liberty or under guardianship
结局指标
主要结局
The study will compare OSA prevalence in a group of patient curatively resected for NASH-related HCC with a group of HCV-related HCC.
时间窗: 2 years
Number of patient presenting an obstructive apnea syndrome diagnosed by oxymetry
次要结局
- The study will compare the 2% oxygen desaturation index between groups.(2 years)
- The study will compare the 3% oxygen desaturation index between groups.(2 years)
- This study will compare the number of micro-arousals between groups.(2 years)
- This study will compare the Epworth Sleepiness Score between groups.(2 years)
- The study will compare HCC tumor differentiation degree between groups.(2 years)
- The study will compare the number of satellite nodules of HCC between between groups.(2 years)
- The study will compare tumor-free survival rate between groups.(2 years)
- The study will compare the 4% oxygen desaturation index between groups.(2 years)
- This study will compare the time spent with a saturation less than 90 % between groups.(2 years)
- This study will compare the Pittsburgh Sleep Quality Index (PSQI) between groups.(2 years)
- The study will compare the prevalence of OSA in patients with NASH-induced CHC with cirrhotic context compared to NASH-induced CHC patients without cirrhosis.(2 years)
- The study will compare the NAFLD Activity Score (NAS score) between OSA and non-OSA subgroups of NASH patients.(2 years)
- The study will compare the METAVIR score data between HCV OSA and HCV non-OSA patients.(2 Years)
- The study will compare BCLC classification of HCC tumor between groups.(2 years)
- The study will compare HCC tumor size between each groups.(2 years)
- The study will compare overall survival rate between groups.(2 years)
- The study will compare non-recurrence-free survival rate between groups.(2 years)
- The study will compare the Brunt score between OSA and non-OSA subgroups of NASH patients.(2 Years)
- The study will compare vascular invasion of HCC tumor between groups.(2 years)
- The study will compare plasma alpha fetoprotein level between groups.(2 years)