Recurrence of Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iman Fawzy Montasser, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01520779
First received: January 26, 2012
Last updated: September 29, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • Recurrence of hepatocellular carcinoma [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520779

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

No publications provided

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
Study First Received: January 26, 2012
Last Updated: September 29, 2013
Health Authority: Egypt: Institutional Review Board

Keywords provided by Ain Shams University:
Hepatocellular cacinoma
Radiofrequancy ablation
Intrahepatic recurrence

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

ClinicalTrials.gov processed this record on October 22, 2014