Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease
- Conditions
- Chronic Granulomatous Diseases (CGD) and Liver Lesions
- Interventions
- Device: Cool-tip RF Ablation System
- Registration Number
- NCT01851460
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RFA Cool-tip RF Ablation System All subjects enrolled onto this study will receive treatment of their liver abscess (es) by RFA ablation
- Primary Outcome Measures
Name Time Method Safety of RFA in the treatment of liver abscesses in CGD subjects Fater each patient completes the study The primary objective of this study is to determine the safety of radiofrequency ablation (RFA) in the treatment of liver abscesses in subjects with chronic granulomatous disease (CGD).
- Secondary Outcome Measures
Name Time Method Compare recovery outcomes After last patient completes the study To compare the recovery outcomes of patients undergoing RFA versus historical controls for patients undergoing surgery for treatment of liver abscesses
Determine if RFA is a reasonable treatment options After last patient completes the study To determine if RFA is a reasonable treatment option for patients with liver abscesses who are not suitable candidates for completely curative hepatic surgery
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
🇺🇸Bethesda, Maryland, United States