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Recurrence of Hepatocellular Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01520779
First Posted: January 30, 2012
Last Update Posted: October 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Iman Fawzy Montasser, Ain Shams University
  Purpose
analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular carcinoma within 1 year after radiofrequency ablation.

Condition
Hepatocellular Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Factors for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation

Further study details as provided by Iman Fawzy Montasser, Ain Shams University:

Primary Outcome Measures:
  • Recurrence of hepatocellular carcinoma [ Time Frame: 1 year ]

Enrollment: 99
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with recurrence
Hepatocellular carcinoma patients with intra-hepatic or distant recurrence of hepatocellular carcinoma within 1 year after radiofrequency ablation
Patients with no recurrence
Hepatocellular carcinoma with no intra-hepatic or distant recurrence of hepatocellular carcinoma within 1 year after radiofrequency ablation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hepatocellular carcinoma (HCC) who underwent radiofrequency ablation (RFA) from 1/2006 till 12/2010in Tropical medicine department and hepatocellular carcinoma clinic, Ain Shams university
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520779


Locations
Egypt
Tropical medicine department
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
  More Information

Responsible Party: Iman Fawzy Montasser, Lecturer of tropical medicine , Ain Shams university, Ain Shams University
ClinicalTrials.gov Identifier: NCT01520779     History of Changes
Other Study ID Numbers: HCC recurrence after RFA
First Submitted: January 26, 2012
First Posted: January 30, 2012
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by Iman Fawzy Montasser, Ain Shams University:
Hepatocellular cacinoma
Radiofrequancy ablation
Intrahepatic recurrence

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes