Evaluation of Liver Fibrosis in Chronic Hepatitis B Patients With 2D Shear Wave Elastography With Propagation Map: A Single Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Comparison of liver stiffness levels of group 1 and group 2 patients
研究概览
简要总结
The aims of this study are to evaluate liver fibrosis with two-dimensional (2D) shear wave elastography (SWE) technique in inactive hepatitis B surface antigen (HBsAg) carriers and patients with active chronic hepatitis B (CHB), with the help of a propagation map, compare this method with histopathological results in patients with CHB and determine the suitability of 2D-SWE for use instead of liver biopsy by evaluating fibrosis before and after treatment.
详细描述
A total of 253 patients with CHB and inactive HBsAg carriers as well as a control group of 30 healthy individuals were included in the study between January 2019 and October 2020. Liver stiffness measurements with 2D-SWE, fibrosis-4 (FIB-4) and aspartate aminotransferase to platelet ratio index (APRI) scoring and additional liver biopsy in patients with CHB were performed in all cases with the help of the propagation map. Depending on the degree of fibrosis, liver stiffness was measured again at 24 and 48 weeks in patients who received antiviral therapy. Spearman rank correlation test was used for analysing correlation between variables, and receiver operating curve analysis was used to evaluate diagnostic performance in terms of fibrosis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being infected with the hepatitis B virus,
- •> 18 years old
- •< 64 years old
排除标准
- •Co-infection with hepatitis C or D
- •Have chronic or acute fulminant liver disease
- •Have DM disease
- •Hypertriglyceridemia, obesity, grade2 and higher hepatosteatosis,
- •Long-term drug use, alcohol intake that may damage the liver
- •Under the age of eighteen
- •Over sixty-five years old
- •Transplantation patients
结局指标
主要结局
Comparison of liver stiffness levels of group 1 and group 2 patients
时间窗: 1st week, 24th week and 48th week
Liver stiffness levels of group 1 and group 2 patients were compared by measuring in kPa and m / s using 2D-SWE technique. Possible increase and decrease values in liver stiffness measurements were calculated at 24 and 48 weeks in subjects who received antiviral therapy.
次要结局
未报告次要终点
研究者
Seyhmus Kavak
MD, Radiologist
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital