Carcinoma, Hepatocellular, Chronic Hepatitis B
Conditions
Keywords
HBV DNA, HCC, recurrence, PEIT, RFTA
Brief summary
The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs) related with HBV.
Detailed description
Prospective cohort study Survival * Overall survival rate * Disease free survival rate Recurrence * Cumulative recurrence rate
Interventions
PROCEDUREPEIT
Percutaneous Ethanol Injection Therapy
PROCEDURERFTA
Radiofrequency Thermal Ablation
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Child-Pugh Class A or B * Maximal tumor size less than 5 cm * No previous history of treatment for hepatocellular carcinoma * Recurrent hepatocellular carcinoma located more than 2 cm from the previous cancer site and is found more than 1 year's gap
Exclusion criteria
* Hepatocellular carcinoma in portal vein * Hepatocellular carcinoma in hepatic vein
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) | 1,3,5 year | The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | through study completion, an average of 3 years | Overall Survival: Number of Participants who Died |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PEIT 99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions. | 60 |
| RFTA high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session. | 85 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | short follow-up duration < 12 months | 1 | 0 |
Baseline characteristics
| Characteristic | Total | PEIT | RFTA |
|---|---|---|---|
| Age, Continuous | 56 years | 56 years | 58 years |
| Region of Enrollment Korea, Republic of | 145 participants | 60 participants | 85 participants |
| Sex: Female, Male Female | 26 Participants | 15 Participants | 11 Participants |
| Sex: Female, Male Male | 119 Participants | 45 Participants | 74 Participants |
| Treatment modality | 145 participants | 60 participants | 85 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 85 |
| other Total, other adverse events | 0 / 60 | 0 / 85 |
| serious Total, serious adverse events | 0 / 60 | 0 / 85 |
Outcome results
Primary
1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)
The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.
Time frame: 1,3,5 year
Population: ITT analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEIT | 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) | 5 year-disease free survival | 26 participants |
| PEIT | 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) | 1 year-disease free survival | 11 participants |
| PEIT | 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) | 3 year-disease free survival | 25 participants |
| RFTA | 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) | 5 year-disease free survival | 37 participants |
| RFTA | 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) | 1 year-disease free survival | 13 participants |
| RFTA | 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) | 3 year-disease free survival | 34 participants |
Secondary
Overall Survival
Overall Survival: Number of Participants who Died
Time frame: through study completion, an average of 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEIT | Overall Survival | 0 participants |
| RFTA | Overall Survival | 0 participants |