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Radiofrequency Ablation (RFA) for the Treatment of Liver Abscesses in Patients With Chronic Granulomatous Disease


Phase 1
18 Years
75 Years
Open (Enrolling)
Both
Radiofrequency Ablation, Liver Abscesses -Staphylococcus Infection, CGD, Chronic Granulomatous Disease, RFA

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Trial Information

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.

Inclusion Criteria


- INCLUSION/ELIGIBILITY CRITERIA:

A patient will be included if he or she meets all of the following criteria:

1. Has documented chronic granulomatous disease

2. Age 18 - 75

3. Has a liver abscess infected with Staphylococcus aureus, but is not an optimal
candidate for curative surgical resection either due to location of disease,
multiplicity of disease, or previous surgery or other comorbidities, such as
pulmonary insufficiency, or has other contraindications to general anesthesia or
perioperative management or refuses surgery.

4. Is willing to return to NIH for imaging scans

5. Is willing to undergo testing or procedures associated with this protocol

6. Has failed long term antibiotic treatment and abscess drainage if applicable.

EXCLUSION CRITERIA:

A patient will be excluded if he or she satisfies 1 or more of the following criteria:

1. Positive results for toxin-producing bacteria obtained from liver biopsy in the
pertinent abscess.

2. Is a good candidate for liver-curative open surgical resection and does not refuse
the surgery

3. Is not a candidate for RFA therapy due to lesion size, location, and/or infection
with a non staphylococcal bacteria.

4. Has a prothrombin time (PT) or partial thromboplastin time (PTT) > 1.5 times normal
(except in patients who have a known lupus anticoagulant or other condition which a
hematologist deems will not cause excessive bleeding despite the abnormal coagulation
parameters).

5. Has a platelet count < 50,000/mm(3) which cannot be maintained despite platelet
transfusions.

6. If you are pregnant.

7. Any condition that, in the investigator's opinion, places the patient at undue risk
by participating in the study

Please Note: Co-morbidities in critically ill patients will not themselves constitute
exclusion criteria because the cause of their illness/condition may require the use of RFA
as a less invasive treatment than surgery.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Elizabeth M Kang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Allergy and Infectious Diseases (NIAID)

Authority:

United States: Federal Government

Study ID:

130117

NCT ID:

NCT01851460

Start Date:

April 2013

Completion Date:

February 2023

Related Keywords:

  • Radiofrequency Ablation
  • Liver Abscesses -Staphylococcus Infection
  • CGD
  • Chronic Granulomatous Disease
  • RFA
  • Radiofrequency Ablation (RFA)
  • Liver Abscesses
  • Congenital Immunodeficiency
  • Chronic Granulomatous Disease (CGD)
  • Non-toxin producing Staphylococcus Aureus
  • Inoperable Liver Abscesses
  • Abscess
  • Granulomatous Disease, Chronic
  • Liver Abscess
  • Staphylococcal Infections
  • Granuloma

Name

Location
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892