Recurrence of Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Risk Factors for Recurrence of Hepatocellular Carcinoma After Radiofrequency Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520779
• Other study ID #: HCC recurrence after RFA
• Status: Completed
• Phase: N/A
• First received: January 26, 2012
• Last updated: September 29, 2013
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: September 2013
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Locations

Country	Name	City	State
Egypt	Tropical medicine department	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of hepatocellular carcinoma		1 year	No