Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease
Withdrawn before enrolling · Phase 1
Conditions studied: Chronic Granulomatous Diseases (CGD) and Liver Lesions
In brief
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.
Key facts
- Study ID
- NCT01851460
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 0
- Starts
- 2013-05-08
- Expected to finish
- 2020-03-24
- Last updated by the study team
- 2020-03-26
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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