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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-I-0117

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 75

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Radiofrequency Ablation (RFA);
Liver Abscesses;
Congenital Immunodeficiency;
Chronic Granulomatous Disease (CGD);
Non-toxin producing Staphylococcus Aureus;
Inoperable Liver Abscesses

Recruitment Keyword(s)

None

Condition(s)

Radiofrequency Ablation;
Liver Abscesses -Staphylococcus Infection;
CGD;
Chronic Granulomatous Disease;
RFA

Investigational Drug(s)

Cool-Tip Radiofrequency (RF) Ablation System

Investigational Device(s)

None

Intervention(s)

Procedure/Surgery: RFA - Radiofrequency Ablation
Procedure/Surgery: Scans - Liver
Procedure/Surgery: Liver
Procedure/Surgery: Drawn

Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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Eligibility

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.


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Citations:

Rossi S, Di Stasi M, Buscarini E, Cavanna L, Quaretti P, Squassante E, Garbagnati F, Buscarini L. Percutaneous radiofrequency interstitial thermal ablation in the treatment of small hepatocellular carcinoma. Cancer J Sci Am. 1995 May-Jun;1(1):73-81.

Siperstein AE, Rogers SJ, Hansen PD, Gitomirsky A. Laparoscopic thermal ablation of hepatic neuroendocrine tumor metastases. Surgery. 1997 Dec;122(6):1147-54; discussion 1154-5.

Rossi S, Di Stasi M, Buscarini E, Quaretti P, Garbagnati F, Squassante L, Paties CT, Silverman DE, Buscarini L. Percutaneous RF interstitial thermal ablation in the treatment of hepatic cancer. AJR Am J Roentgenol. 1996 Sep;167(3):759-68.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Elizabeth M. Kang, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
BG 10-CRC RM 6-3750
10 CENTER DR
BETHESDA MD 20814
(301) 402-7567
ekang@niaid.nih.gov

Patricia L. Littel, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 6-3750
10 Center Drive
Bethesda, Maryland 20892
(301) 402-5964
plittel@cc.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01851460

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