A Retrospective Review of Malignant Liver Tumors

NCT ID: NCT00728650

Last Updated: 2012-02-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 228 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2011-06-30

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.

Conditions

Liver Cancer

Study Design

• Study Time Perspective: RETROSPECTIVE

Study Groups

Observation

Patients with primary or metastatic hepatic malignancies

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with primary or metastatic hepatic malignancies

Exclusion Criteria

• Patients not diagnosed with primary or metastatic hepatic malignancies

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas A Broughan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma-Tulsa

Locations

The University of Oklahoma College of Medicine, Tulsa - Department of Surgery

Tulsa, Oklahoma, United States

Countries

United States

References

Curley SA, Izzo F, Delrio P, Ellis LM, Granchi J, Vallone P, Fiore F, Pignata S, Daniele B, Cremona F. Radiofrequency ablation of unresectable primary and metastatic hepatic malignancies: results in 123 patients. Ann Surg. 1999 Jul;230(1):1-8. doi: 10.1097/00000658-199907000-00001.

Reference Type: RESULT

PMID: 10400029 (View on PubMed)

Other Identifiers

TAB11119

Identifier Type: -

Identifier Source: org_study_id