A Retrospective Review of Malignant Liver Tumors

Completed

• Conditions: Liver Cancer

• Registration Number: NCT00728650
• Lead Sponsor: University of Oklahoma

Brief Summary

This study will review the treatment and outcomes of patients having primary and metastatic hepatic malignancies. Patients treated with surgical resection, percutaneous radiofrequency ablation (RFA), and transarterial chemoembolization (TACE) will be compared with patients not receiving these treatments. Tumor recurrence and survival data will be compared to the published literature to determine the efficacy of current treatment strategies in this patient population.

Detailed Description

Subjects will be identified by diagnosis and procedure codes from a university surgical practice and the St. John Medical Center Cancer Registry. Data will be obtained by review of both the clinic and hospital charts. In addition we plan to review and utilize liver tumor treatment and outcomes data from a national database. Treatment decisions, in cases managed by the primary investigator, were made on a clinical basis, often in collaboration with an interventional radiologist. Of the patients managed by the principal investigator, all procedures were undertaken after an informed consent process. Subjects were not exposed to risk beyond that posed by the recommended treatment. All treatments were within the scope of standard medical care. The primary investigator has no knowledge of the treatments chosen for the patients he did not manage. The subject's referring physician may be contacted to obtain follow-up data on the subject. The follow-up data will include: is the patient alive with disease; alive without disease, alive unknown; dead free of disease; dead with disease; dead unknown.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-01
• Study First Posted: 2008-08-06
• Primary Completion: 2010-10
• Study Completion: 2011-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-06
• Last Update Posted: 2012-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

• Patients with primary or metastatic hepatic malignancies

Exclusion Criteria

• Patients not diagnosed with primary or metastatic hepatic malignancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	lifetime

Secondary Outcome Measures

Name	Time	Method
Efficacy	lifetime

Trial Locations

Locations (1)

The University of Oklahoma College of Medicine, Tulsa - Department of Surgery; 🇺🇸 Tulsa, Oklahoma, United States