Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease
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ClinicalTrials.gov Identifier: NCT01851460 |
Recruitment Status
:
Recruiting
First Posted
: May 10, 2013
Last Update Posted
: March 29, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Granulomatous Disease (CGD) | Device: Cool-tip RF Ablation System | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Radiofrequency Ablation (RFA) for the Treatment of Liver Abscesses in Patients With Chronic Granulomatous Disease |
Study Start Date : | May 8, 2013 |
Estimated Primary Completion Date : | January 1, 2020 |
Estimated Study Completion Date : | January 1, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: RFA
All subjects enrolled onto this study will receive treatment of their liver abscess (es) by RFA ablation
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Device: Cool-tip RF Ablation System
RFA therapy will be administered according to the instructions of the RFA device manufacturer.
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- The primary objective of this study is to determine the safety ofradiofrequency ablation (RFA) in the treatment of liver abscesses insubjects with chronic granulomatous disease (CGD). [ Time Frame: Throughout ]
- To determine if RFA is a reasonable treatment option for patients with liver abscesses who are not suitable candidates for completely curative hepatic surgery [ Time Frame: Throughout ]
- To compare the recovery outcomes of patients undergoing RFA versus historical controls for patients undergoing surgery for treatment of liver abscesses [ Time Frame: Throughout ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- INCLUSION/ELIGIBILITY CRITERIA:
A patient will be included if he or she meets all of the following criteria:
- Has documented chronic granulomatous disease
- Age 18 - 75
- 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.
- Is willing to return to NIH for imaging scans
- Is willing to undergo testing or procedures associated with this protocol
- 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:
- Positive results for toxin-producing bacteria obtained from liver biopsy in the pertinent abscess.
- Is a good candidate for liver-curative open surgical resection and does not refuse the surgery
- Is not a candidate for RFA therapy due to lesion size, location, and/or infection with a non staphylococcal bacteria.
- 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).
- Has a platelet count <50,000/mm(3) which cannot be maintained despite platelet transfusions.
- If you are pregnant.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851460
Contact: Patricia L Littel, R.N. | (301) 402-5964 | plittel@cc.nih.gov | |
Contact: Elizabeth M Kang, M.D. | (301) 402-7567 | ekang@niaid.nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov |
Principal Investigator: | Elizabeth M Kang, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
Additional Information:
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT01851460 History of Changes |
Other Study ID Numbers: |
130117 13-I-0117 |
First Posted: | May 10, 2013 Key Record Dates |
Last Update Posted: | March 29, 2018 |
Last Verified: | November 22, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Staphylococcus Infection RFA Hepatic CGD |
Additional relevant MeSH terms:
Granulomatous Disease, Chronic Granuloma Liver Abscess Lymphoproliferative Disorders Lymphatic Diseases Pathologic Processes Phagocyte Bactericidal Dysfunction Leukocyte Disorders Hematologic Diseases Genetic Diseases, X-Linked |
Genetic Diseases, Inborn Immunologic Deficiency Syndromes Immune System Diseases Abdominal Abscess Abscess Suppuration Infection Liver Diseases Digestive System Diseases |