跳至主要内容
临床试验/NCT03221049
NCT03221049Unknown不适用

the Department of Medical Ultrasonics, Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Guangzhou, China.

Third Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,000
试验地点
1
主要终点
benign or malignance

研究概览

简要总结

Liver diseases are worldwide problems. liver fibrosis and hepatocellular carcinoma are mostly concerned by clinicians. Radiomcis can improve diagnosis accuracy and evaluate disease progression. Hence,investors try to combine radiomics and ultrasound images together in order to improve diagnosis performances of liver fibrosis, benign and malignant tumor and progression after liver ablations.

详细描述

Liver diseases are worldwide problems including diffuse hepatitis disease and liver space occupying lesions. Hepatitis B virus infection is the most important one among difuse hepatitis disease. There are 240 million people infected with HBV globally, and more than one-third of these patients (approximately 93 million) live in China. For them, a precise estimation of the degree of liver fibrosis is important for estimation of prognosis, surveillance, and treatment decisions in patients with HBV infection. Hepatocellular carcinoma is usually detected in liver space occupying lesions and leading to third common death of cancer. Hence, precise diagnosis between benign and malignant tumor is of great significance. Many guidelines recommend ablation as first line treatment to small hepatocellular carcinoma, especially to those less than 1mm.

Liver biopsy has been considered the gold standard for assessing liver diseases. However, it is limited because of sample errors, interobserver variability and many complications, such as pain, bleeding and even death. CT/MR are alternative ways with high cost and complications. Ultrasound was a first optional tool to diagnose liver disease. However, there are still some problems remained to solve:first, the diagnosis accuracy of liver fibrosis remained to be improved. Second,the diagnosis performances for distinguishing benign and malignant tumor were poor. Third, there were not objective way to assess progression after liver ablations.

Radiomcis refers to the extraction and analysis of large amounts of image features from medical images. Previous studies showed that it can improve diagnosis accuracy and evaluating disease progression. Hence,we tried to combined radiomics and ultrasound images together in order to improve diagnosis performances of liver fibrosis, benign and malignant tumor and progression after liver ablations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • HBsAg positive or HBV-DNA detected
  • agreed to undergo liver biopsy
  • agreed to participated in our study

排除标准

  • combined with other liver disease(eg. HAV/HCV/HDV,alcoholic liver disease)
  • combined with HIV
  • combined with malignant liver space occupying lesions
  • liver transplantation
  • the sample size of liver biopsy could not demand: length lower than 15mm, portal areas less than
  • For patients classified between benign and malignant tumor
  • Inclusion Criteria:
  • patients diagnosed with liver space occupying lesions
  • with histology results of liver space occupying lesions.
  • agreed to participate in our study and signed informed consent.
  • Exclusion Criteria:
  • ultrasound images cant meet the demand for analysis
  • without histology results
  • For patients to estimate progression after ablation
  • Inclusion Criteria:
  • patients diagnosed with hepatocellular carcinoma;
  • patients treated with ablation;
  • patients performed the contrast-enhanced ultrasonography before ablation;
  • patients who treated with transcatheter arterial chemoembolization (TACE) performed the contrast-enhanced ultrasonography performed before TACE;
  • Exclusion Criteria:
  • patients with lack of US digital imaging data
  • loss to follow-up

结局指标

主要结局

benign or malignance

时间窗: 5 years

the malignance of liver space occupying lesions

liver fibrosis

时间窗: 1 year

the degree of liver fibrosis

The incidence of recurrence

时间窗: 5 years

the incidence of liver cancer recurrence after ablation

次要结局

未报告次要终点

研究者

发起方
Third Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rongqin Zheng

Professor

Third Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

Loading locations...

相似试验

Radiomics for Diagnosing Liver Diseases and... | 临床试验