Hepatocellular Carcinoma Non-resectable
Conditions
Keywords
Percutaneuos Ethanol alcohol injection
Brief summary
Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the large and unresectable hepatocellular carcinoma: 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 (PAT or PEI) for the large and inoperable hepatocellular carcinoma. This is a prospective non randomized trial carried out at the Ribat University Hospital between May 2017 to April 2020.
Interventions
PROCEDUREPercutaneous ethanol alcohol injection
Day-case procedure; weekly sessions; uses absolute alcohol; under close monitoring; maximum dose of 30 ml; no anesthesia needed and a maximum pain score of 8 limits the procedure. Post-procedure analgesia may be required.
Sponsors
The National Ribat University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking
Intervention model description
Single Group Assignment. Prospective and non-randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 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 thrombocytopenia; * Unable or unwilling to attend follow up visits and examinations; * Other associated surgical procedure;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival rate | 3 years | The percentage of HCC patients who are still alive for three years after they started PEI for 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 PEI. |
| Major complications' rate | 3 years | Incidence of post-procedure 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
Outcome results
None listed