Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease (NCT01851460) | Clinical Trial Compass
WithdrawnPhase 1
Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease
Stopped: PI choose to close the study
United States0Started 2013-05-08
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion 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
✕. 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.
What they're measuring
1
Safety of RFA in the treatment of liver abscesses in CGD subjects
Timeframe: Fater each patient completes the study
Trial details
NCT IDNCT01851460
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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