Status:
WITHDRAWN
Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Chronic Granulomatous Diseases (CGD) and Liver Lesions
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 disorde...
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, ...
Eligibility Criteria
Inclusion
- 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 or other microorganism susceptible to RFA, 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 or location.
- 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.
Exclusion
Key Trial Info
Start Date :
May 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01851460
Start Date
May 8 2013
End Date
March 24 2020
Last Update
March 26 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892