Outcome of Hepatocellular Carcinoma Patients With Portal Vein Thrombosis After Trans-Arterial Chemo Embolization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- mortality
研究概览
简要总结
Hepatocellular carcinoma (HCC) is the fifth most common neoplasm worldwide and the third most frequent cause of death from cancer in the world. Hepatocellular carcinoma is responsible for significant morbidity and mortality in cirrhosis. Most cases of HCC occur in the setting of cirrhosis and, therefore, prognosis is determined not only by factors related to the tumor but also by factors related to cirrhosis (1).
According to previous reports, the incidence of HCC with partial portal vein thrombosis (PVTT) ranges between 44% and 62.2%. HCC associated with PVTT has a poor prognosis. It may lead to intrahepatic metastasis, liver dysfunction, and portal hypertension. The median overall survival for HCC patients with untreated PVTT is only 2.7 months (2).
It was suggested that HCC with PVTT should be classified as stage C based on Barcelona Clinic Liver Cancer; it is no longer surgically treatable. Compared with conservative treatment, TACE is a safe and effective therapy for such cases. However, this modality for treatment might be associated with mortality (3).
As far as we know, there is no studies of short-term survival in patients with HCC and PVT after TACE in our locality.
Our study aims to determine frequency of short-term mortality (< 3month) among HCC patients with PPVT after TACE, and to explore its predictors.
详细描述
Type of the study:cohort study Study Setting: Assiut University Hospitals
Sample Size Calculation:
Total coverage sample technique will be applied in the current study where all patients who are fulfilling inclusion criteria during the study period will be included.
Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...):
For all the study patients, clinical evaluation (including demographic data and body mas index), laboratory investigations (including liver and kidney chemistry, INR, and complete blood picture), and imaging studies (including abdominal ultrasonography, doppler ultrasonography, and contrast computed tomography) will be provided.
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
- •Age > 18 years old
- •HCC was diagnosed based on contrast imaging
- •PPVT was diagnosed based on abdominal Duplex
排除标准
- •Age < 18 years old
- •Complete PVT
- •Any previous therapy for HCC
- •Extrahepatic concomitant malignancy
结局指标
主要结局
mortality
时间窗: 3 months
frequency of short term mortality
次要结局
未报告次要终点
研究者
Alshaimaa Eid
Resident doctor
Assiut University