Trial Outcomes & Findings for The Effect of Viral Load on Intrahepatic Recurrence in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) (NCT NCT00397540)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

145 participants

Primary outcome timeframe

1,3,5 year

Results posted on

2019-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Percutaneous Ethanol Injection Therapy 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.	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.
Overall Study STARTED	60	85
Overall Study COMPLETED	59	85
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Percutaneous Ethanol Injection Therapy 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.	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.
Overall Study short follow-up duration < 12 months	1	0

Baseline Characteristics

The Effect of Viral Load on Intrahepatic Recurrence in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEIT n=60 Participants 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.	RFTA n=85 Participants high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.	Total n=145 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	58 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	74 Participants n=7 Participants	119 Participants n=5 Participants
Region of Enrollment Korea, Republic of	60 participants n=5 Participants	85 participants n=7 Participants	145 participants n=5 Participants
Treatment modality	60 participants n=5 Participants	85 participants n=7 Participants	145 participants n=5 Participants

PRIMARY outcome

Timeframe: 1,3,5 year

Population: ITT analysis

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.

Outcome measures

Outcome measures
Measure	PEIT n=62 Participants 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.	RFTA n=84 Participants high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) 1 year-disease free survival	11 participants	13 participants
1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) 3 year-disease free survival	25 participants	34 participants
1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) 5 year-disease free survival	26 participants	37 participants

SECONDARY outcome

Timeframe: through study completion, an average of 3 years

Overall Survival: Number of Participants who Died

Outcome measures

Outcome measures
Measure	PEIT n=60 Participants 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.	RFTA n=85 Participants high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
Overall Survival	0 participants	0 participants

Adverse Events

Percutaneous Ethanol Injection Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RFTA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Won Kim

Seoul National University Hospital Boramae Medical Center

Phone: 82 2 870 2233

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place