Clinical trial NCT00728650: A Retrospective Review of Malignant Liver Tumors
Official title: A Retrospective Review of Malignant Liver Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer
Keywords: hepatocellular carcinoma
colorectal carcinoma metastatic to liver
primary liver cancer
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-08-06
Enrollment: 228
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic and patients treated at St. John Medical Center in Tulsa, OK

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.

Eligibility criteria: Inclusion Criteria:

* Patients with primary or metastatic hepatic malignancies

Exclusion Criteria:

* Patients not diagnosed with primary or metastatic hepatic malignancies

Primary outcomes:
measure: Survival
timeFrame: lifetime
Secondary outcomes:
measure: Efficacy
timeFrame: lifetime
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: The University of Oklahoma College of Medicine, Tulsa - Department of Surgery
state: Oklahoma
Study officials:
affiliation: University of Oklahoma-Tulsa
name: Thomas A Broughan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.