- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01851460
Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease
Radiofrequency Ablation (RFA) for the Treatment of Liver Abscesses in Patients With Chronic Granulomatous Disease
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of RFA in the treatment of liver abscesses in CGD subjects
Time Frame: Fater each patient completes the study
|
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).
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Fater each patient completes the study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine if RFA is a reasonable treatment options
Time Frame: After last patient completes the study
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To determine if RFA is a reasonable treatment option for patients with liver abscesses who are not suitable candidates for completely curative hepatic surgery
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After last patient completes the study
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Compare recovery outcomes
Time Frame: After last patient completes the study
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To compare the recovery outcomes of patients undergoing RFA versus historical controls for patients undergoing surgery for treatment of liver abscesses
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After last patient completes the study
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Hematologic Diseases
- Liver Diseases
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Leukocyte Disorders
- Suppuration
- Phagocyte Bactericidal Dysfunction
- Abdominal Abscess
- Abscess
- Granuloma
- Granulomatous Disease, Chronic
- Liver Abscess
Other Study ID Numbers
- 130117
- 13-I-0117
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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