Outcome of Hepatocellular Carcinoma Patients With Portal Vein Thrombosis After Trans-Arterial Chemo Embolization
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 30
- Primary Endpoint
- mortality
Overview
Brief Summary
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.
Detailed Description
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.
CTP and MELD scores will be calculated.
Data management and analysis (Details needed):
Data collection: will include patients between 2015 and 2023. Computer software
Statistical tests:
Based on short term survival, eligible patients will be subdivided into two groups either survivors or non-survivors. Continuous data will be given in form of mean (SD) and compared by Student t test while nominal data will be expressed as frequency (percentage) and chi square test is used for such data.
Overall survival analysis will be done by Kaplan Meier survival curve. Logistic regression analysis will be applied to determine the possible predictors for short term mortality.
Level of confidence is kept at 95% and hence, p value is considered significant if < 0.05. Analysis of data will be done by SPSS 28 software
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age \> 18 years old
- •HCC was diagnosed based on contrast imaging
- •PPVT was diagnosed based on abdominal Duplex
Exclusion Criteria
- •Age \< 18 years old
- •Complete PVT
- •Any previous therapy for HCC
- •Extrahepatic concomitant malignancy
Outcomes
Primary Outcomes
mortality
Time Frame: 3 months
frequency of short term mortality
Secondary Outcomes
No secondary outcomes reported
Investigators
Alshaimaa Eid
Resident doctor
Assiut University