Radiofrequency Ablation (RFA) for the Treatment of Liver Abscesses in Patients With Chronic Granulomatous Disease
Radiofrequency Ablation (RFA) has become an increasingly common therapeutic treatment for
neoplasms in the liver. A number of devices are now Food and Drug Administration cleared for
this indication, and a growing body of literature supports this technique as a therapeutic
option for patients with primary or metastatic hepatic malignancies. In vivo animal studies
have also shown that this technique can also be used to treat infections. Insertion of the
thermal energy delivery probe into an infected liver abscess destroys the bacteria while
preserving surrounding tissue. Off-label use of RFA was successfully used to treat 22
abscesses in 4 patients with chronic granulomatous disease who had inoperable liver
abscesses. The proposed clinical trial will specifically evaluate the feasibility, safety,
and to a lesser extent, efficacy of RFA to treat liver abscesses in subjects with previously
diagnosed chronic granulomatous disease. This will be a non-randomized case study conducted
at the Clinical Center at the National Institutes of Health. One RFA device will be used.
Ten subjects will be enrolled. If the method proves to be both feasible and safe, detailed
analysis on efficacy will be performed. RFA eventually could play an important clinical role
in patients with chronic granulomatous disease and liver abscesses that are not amenable to
surgical management and are without other effective therapeutic options, or might otherwise
be incompletely treated with surgical resection and debridement alone.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint for this study is patient safety, defined as no occurrences of Grade 3 or higher toxicities and are at least possibly related to the study intervention.
Elizabeth M Kang, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|