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临床试验/NCT04191018
NCT04191018Unknown不适用

Progression of Gastroesophageal Varices After Sustained Virological Response by Interferon-free Regimens in Patients With Advanced Fibrosis / Cirrhosis Due to Chronic Hepatitis C

Oswaldo Cruz Foundation2 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2019年11月26日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
322
试验地点
2
主要终点
Validation of the Baveno's criteria to avoid gastrointestinal endoscopy for screening of esophageal varices after SVR

研究概览

简要总结

Chronic hepatitis C remains a public health issue because up to 70 million people are chronically infected by hepatitis C virus (HCV) worldwide. Presence of advanced fibrosis/cirrhosis might be associated with liver-related complications, such as hepatocellular carcinoma and oesophageal varices bleeding. Oesophageal varices (OV) might be present in up to 40% of patients with liver cirrhosis have and the mortality rates from bleeding might be up to 20% per episode. Early diagnosis of advanced fibrosis/cirrhosis associated with hepatitis C treatment are key features for preventive and therapeutic measures to reduce liver-related mortality in HCV-infected patients.

Liver elastography is a high accurate non-invasive test for diagnosis of advanced fibrosis/cirrhosis. Few different methods of liver elastography are currently available: transient elastography by Fibroscan and ultrasound elastography by point-shear wave (p-SWE) and 2D-shear wave (2D-SWE). Gastrointestinal endoscopy (GIE) has been considered the gold standard for screening or surveillance of esophageal varices. More recently, international guidelines have been recommending the use of non-invasive methods to indicate or avoid OV screening: Baveno VI guidelines proposed that compensated cirrhotic patients with a liver stiffness measurement (LSM) by transient elastography <20kPa and a platelet count >150,000/μL can avoid screening endoscopy. The use of direct-acting agents (DAAs) has revolutionized the treatment of chronic hepatitis C with high effectiveness shown using all-oral interferon-free regimens. HCV cure, sustained virological response (SVR), has been associated with lower rates of liver-related complications, increase in quality of life and decrease in waiting-list registrations for liver transplantation in patients with chronic hepatitis C. Preliminary studies have been reporting significant regression liver stiffness after SVR. However, it is unclear whether SVR might decrease portal hypertension leading to OV regression and a reduced risk of variceal bleeding. In addition, the use of non-invasive methods to avoid OV screening must be validated in HCV patients after SVR. The aims of this cross-sectional study with prospective inclusion of patients will be: (i) to evaluate the impact of SVR in portal hypertension in HCV patients with advanced fibrosis/liver cirrhosis treated by interferon-free regimens and (ii) to validate non-invasive methods to avoid OV screening by GIE

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Presence of advanced fibrosis or cirrhosis (stage F≥3 METAVIR) based on liver stiffness by transient elastography (≥ 9,5 kPa) or liver biopsy
  • Gastrointestinal endoscopy at least 24 months before start of direct-acting agents for HCV treatment
  • Liver stiffness measurement at least 18 months after SVR

排除标准

  • Autoimmune hepatitis, hepatosplenic schistosomiasis or cholestasis diseases
  • Liver transplantation
  • Presence of high volume ascites or hepatocellular carcinoma
  • Participation in programs of esophageal band ligation for eradication of esophageal varices
  • Presence of signs of acute decompensated liver disease

结局指标

主要结局

Validation of the Baveno's criteria to avoid gastrointestinal endoscopy for screening of esophageal varices after SVR

时间窗: up to 48 months after SVR

Validation of the diagnostic performance of non-invasive tests (liver and splenic stiffness or biological markers) to screen esophageal varices in patients with advanced fibrosis/cirrhosis after SVR by DAA treatment for HCV

Incidence of esophageal varices (portal hypertension) after SVR

时间窗: up to 48 months after SVR

Evaluation of presence/absence of esophageal varices after SVR in patients with advanced fibrosis or cirrhosis compared to before treatment

次要结局

  • Incidence of regression of esophageal varices after SVR(up to 48 months after SVR)

研究者

发起方
Oswaldo Cruz Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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