Assessment of the long-term outcome of percutaneous ethanol alcohol injection (PEI) for the large and unresectable hepatocellular carcinoma: single center non-randomized trial.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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.
Ribat University Hospital
Khartoum, Sudan
Overall survival rate
The percentage of HCC patients who are still alive for three years after they started PEI for HCC.
Time frame: 3 years
Disease free survival
Percentage of HCC patients who are alive and well (without a recurrence of their HCC) 3 years after PEI.
Time frame: 3 years
Major complications' rate
Incidence of post-procedure Common Terminology Criteria for Adverse Events (CTCAE v4.03) grade
Time frame: 3 years
Tumor response rate
Mean percentage reduction in the sizes of the patients' tumors
Time frame: 3 years
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