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Trial record 7 of 126 for:    "Viral Infectious Disease" | "Ethanol"

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

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ClinicalTrials.gov Identifier: NCT00397540
Recruitment Status : Completed
First Posted : November 9, 2006
Results First Posted : March 15, 2010
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Hepatocellular
Chronic Hepatitis B
Interventions Procedure: PEIT
Procedure: RFTA
Enrollment 145
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Percutaneous Ethanol Injection Therapy RFTA
Hide Arm/Group Description 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. high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
Period Title: Overall Study
Started 60 85
Completed 59 85
Not Completed 1 0
Reason Not Completed
short follow-up duration < 12 months             1             0
Arm/Group Title PEIT RFTA Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 60 85 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants 85 participants 145 participants
56
(39 to 72)
58
(27 to 71)
56
(27 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 85 participants 145 participants
Female
15
  25.0%
11
  12.9%
26
  17.9%
Male
45
  75.0%
74
  87.1%
119
  82.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 60 participants 85 participants 145 participants
60 85 145
Treatment modality  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 85 participants 145 participants
60 85 145
1.Primary Outcome
Title 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis
Arm/Group Title PEIT RFTA
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 62 84
Measure Type: Number
Unit of Measure: participants
1 year-disease free survival 11 13
3 year-disease free survival 25 34
5 year-disease free survival 26 37
2.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival: Number of Participants who Died
Time Frame through study completion, an average of 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Percutaneous Ethanol Injection Therapy RFTA
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 60 85
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Percutaneous Ethanol Injection Therapy RFTA
Hide Arm/Group Description 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. high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
All-Cause Mortality
Percutaneous Ethanol Injection Therapy RFTA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/85 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Percutaneous Ethanol Injection Therapy RFTA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/85 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Percutaneous Ethanol Injection Therapy RFTA
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/85 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Won Kim
Organization: Seoul National University Hospital Boramae Medical Center
Phone: 82 2 870 2233
EMail: wonshiri@yahoo.com
Layout table for additonal information
Responsible Party: Jung-Hwan Yoon, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00397540     History of Changes
Other Study ID Numbers: 10-2006-001
First Submitted: November 7, 2006
First Posted: November 9, 2006
Results First Submitted: September 22, 2009
Results First Posted: March 15, 2010
Last Update Posted: March 18, 2019