Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, Ipsilateral Liver Lobe Devascularization, Alcohol Treatment, CILDAT
Brief summary
Assessment of the long-term outcome of combined ipsilateral liver lobe devascularization (ILAD) and alcohol injection of the large hepatocellular carcinoma (HCC): single center non-randomized trial.
Detailed description
Assessment of the overall (OS); one year; two years and three years' survival rates; the disease free survival (DFS) and the tumor response rate in the patients undergoing Combined Ipsilateral Liver Lobe Devascularization and Alcohol Treatment (CILDAT) of the Large HCC. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.
Interventions
PROCEDURECombined Treatment
This modality of palliative treatment includes initial surgical operation where arterial vascular supply of the tumor carrying liver lobe of the corresponding hepatic artery as well as the extrahepatic collateral arteries (EHCAs) feeding the large HCC (\> 5 cms size) under general anesthesia. Four weeks after the operation the tumor is injeted (intralesionally and intravascularly) with absolute ethanol alcohol injections on regular weekly percutaneous sessions until the tumor become saturated and its vascularity rendered inactive.
Sponsors
The National Ribat University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, non-randomized and time series clinical trial.
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Review and sign informed consent; * Between 15 and 80 years of age at time of trial enrollment; * Documented pathological and/or radiological diagnosis of hepatocellular carcinoma; * Radiologically documented tumor size of \> 5 centimeters; * Radiologically documented liver cirrhosis.
Exclusion criteria
* American Anesthesia Association (ASA) Class IV or V and/or any contraindications to general anesthesia; * Uncontrollable ascites; * Deep persistent jaundice; * Hepatic encephalopathy; * Coagulopathy; * Severe uncorrectable thrombocytopenia; * Unable or unwilling to attend follow up visits and examinations;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival rate | 3 years | The percentage of patients who are still alive for three years after they started CILDAT for their large HCC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 3 years | Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after CILDAT |
| Major complications' rate | 3 years | Incidence of post CILDAT Clavien-Dindo comlicatins grade 3b or more. |
| Major toxicity rate | 3 years | Incidence of post CILDAT Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade |
| Tumor response rate | 3 years | Mean percentage reduction in the sizes of the patients' tumors |
Countries
Sudan
Contacts
Primary ContactOsama M Elsanousi, MD
Outcome results
None listed