Recurrence of Hepatocellular Carcinoma

NCT ID: NCT01520779

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-12-31

Brief Summary

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analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular carcinoma within 1 year after radiofrequency ablation.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Keywords

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Hepatocellular cacinoma Radiofrequancy ablation Intrahepatic recurrence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with recurrence

Hepatocellular carcinoma patients with intra-hepatic or distant recurrence of hepatocellular carcinoma within 1 year after radiofrequency ablation

No interventions assigned to this group

Patients with no recurrence

Hepatocellular carcinoma with no intra-hepatic or distant recurrence of hepatocellular carcinoma within 1 year after radiofrequency ablation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Proved diagnosis of HCC according to AASLD practice guidelines (Bruix and Sherman, 2005).
2. Patients underwent RFA for HCC with BCLC (The Barcelona-Clinic- Liver-Cancer staging system) stage A (Bruix and Sherman, 2005) with no eligibility or ability to do transplantation or resection.
3. Patients should be followed-up for more than 12 months to exclude early recurrence i.e. recurrence within 1 year.
4. Patients with INR \< 1.5 or prothrombin concentration \> 50%.
5. Platelet count \> 50000 cell/mm3.

Exclusion Criteria

1. Presence of extra-hepatic metastasis or gross vascular invasion.
2. Child class C patients.
3. Follow up period of less than 12 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Iman Fawzy Montasser

Lecturer of tropical medicine , Ain Shams university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tropical medicine department

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HCC recurrence after RFA

Identifier Type: -

Identifier Source: org_study_id