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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.
Prospective cohort study
Survival
Recurrence
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| percutaneous ethanol injection therapy | Active Comparator | Patients with hepatocellular carcinoma who will be treated with PEIT (percutaneous ethanol injection therapy) |
|
| radiofrequency thermal ablation | Active Comparator | Patients with hepatocellular carcinoma who will be treated with RFTA (radiofrequency thermal ablation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEIT | Procedure | Percutaneous Ethanol Injection Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1,3,5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall Survival: Number of Participants who Died | through study completion, an average of 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won Kim, Professor | Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23461618 | Derived | Seo JY, Kim W, Kwon JH, Jin EH, Yu SJ, Kim HY, Jung YJ, Kim D, Kim YJ, Yoon JH, Lee HS. Noninvasive fibrosis indices predict intrahepatic distant recurrence of hepatitis B-related hepatocellular carcinoma following radiofrequency ablation. Liver Int. 2013 Jul;33(6):884-93. doi: 10.1111/liv.12132. Epub 2013 Mar 5. | |
| 22011297 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | RFTA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT analysis | Posted | Number | participants | 1,3,5 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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nothing to comment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Won Kim | Seoul National University Hospital Boramae Medical Center | 82 2 870 2233 | wonshiri@yahoo.com |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D019694 | Hepatitis B, Chronic |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| RFTA | Procedure | Radiofrequency Thermal Ablation |
|
|
| Chung GE, Kim W, Lee JH, Kim YJ, Yoon JH, Lee JM, Lee JY, Kim SH, Kim D, Lee HS. Negative hepatitis B envelope antigen predicts intrahepatic recurrence in hepatitis B virus-related hepatocellular carcinoma after ablation therapy. J Gastroenterol Hepatol. 2011 Nov;26(11):1638-45. doi: 10.1111/j.1440-1746.2011.06777.x. |
high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Treatment modality | Number | participants |
|
|
|
| Secondary | Overall Survival | Overall Survival: Number of Participants who Died | Posted | Number | participants | through study completion, an average of 3 years |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | 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. | 0 | 85 | 0 | 85 | 0 | 85 |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |