Chronic Granulomatous Diseases (CGD) and Liver Lesions Clinical Trial
Official title:
Radiofrequency Ablation (RFA) for the Treatment of Liver Abscesses in Patients With Chronic Granulomatous Disease
Background:
- Abscesses are a pocket of infection in an organ or tissue. Patients with a disease called
chronic granulomatous disease (CGD) often develop these abscesses. CGD is an inherited
disorder that affects how white blood cells function. Liver abscesses in people with CGD
often require surgery to remove them and treat the infection. However, some people with CGD
cannot have full surgery because it would be too risky. Researchers want to try a procedure
called radiofrequency ablation (RFA) to treat these liver abscesses. RFA can usually be done
without a major operation. This study will see if RFA is a safe and effective treatment for
liver abscesses in patients with CGD.
Objectives:
- To see if RFA is a safe and effective treatment for CGD-related liver abscesses.
Eligibility:
- Individuals between 18 and 75 years of age with CGD who have liver abscesses that cannot be
treated with surgery.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine
samples will be collected. Imaging studies will be performed on the liver.
- Participants will have RFA for the abscesses. RFA is an image-guided technique that
heats and destroys specific tissue, such as tumor tissue. It will target any abscesses
on the liver.
- After the procedure, participants will stay in the hospital for monitoring before being
released.
- Participants will have regular follow-up visits for up to 1 year after treatment. Blood
and urine samples will be collected. Additional imaging studies will be performed.
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. ;