Sponsor study identifier
Secondary identifiers
interventional
0
1 country
1
Study Start
May 8, 2013
Actual (reported)Primary Completion
March 24, 2020
Actual (reported)Study Completion
March 24, 2020
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 24, 2020
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 8, 2013
Actual (reported)May 8, 2013
Actual (reported)May 10, 2013
Actual (reported)March 24, 2020
Actual (reported)March 24, 2020
Actual (reported)Safety of RFA in the treatment of liver abscesses in CGD subjects
The primary objective of this study is to determine the safety of radiofrequency ablation (RFA) in the treatment of liver abscesses in subjects with chronic granulomatous disease (CGD).
Fater each patient completes the study
Determine if RFA is a reasonable treatment options
After last patient completes the study
Compare recovery outcomes
After last patient completes the study
All subjects enrolled onto this study will receive treatment of their liver abscess (es) by RFA ablation
RFA therapy will be administered according to the instructions of the RFA device manufacturer. After infiltration of the skin (for percutaneous approach) with a local anesthetic, the needle probe will be directed into the lesion. For all methods, the needle placement is confirmed to be within the lesion by ultrasound or other imaging modality as appropriate. After confirming needle placement, the lesion will be heated to a target temperature of \>75 (Infinite)c for up to 15 minutes. The exposure time may be varied depending on the temperatures achieved. Depending on the size of the lesion to be ablated, multiple passes of the probe as well as multiple ablation cycles may be performed. Adequacy of ablation will be monitored by ultrasound throughout the procedure. Depending on the size of the lesions and the time required to complete the ablation, multiple lesions may be treated as staged procedures so as to improve safety.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Livraghi T. Radiofrequency ablation, PEIT, and TACE for hepatocellular carcinoma. J Hepatobiliary Pancreat Surg. 2003;10(1):67-76. doi: 10.1007/s10534-002-0714-y.
Lublin M, Bartlett DL, Danforth DN, Kauffman H, Gallin JI, Malech HL, Shawker T, Choyke P, Kleiner DE, Schwartzentruber DJ, Chang R, DeCarlo ES, Holland SM. Hepatic abscess in patients with chronic granulomatous disease. Ann Surg. 2002 Mar;235(3):383-91. doi: 10.1097/00000658-200203000-00010.
Elizabeth M Kang, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
0 participants (actual enrollment reported by the registry).
First Submitted
May 8, 2013
First Posted
May 10, 2013
Study Start
May 8, 2013
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
March 24, 2020
Actual (reported)Study Completion
March 24, 2020
Actual (reported)Last Updated
March 26, 2020
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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