Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01851460
First received: May 8, 2013
Last updated: January 16, 2015
Last verified: December 2014
  Purpose

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.

Condition Intervention Phase
Chronic Granulomatous Disease (CGD)
Device: Cool-tip RF Ablation System
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation (RFA) for the Treatment of Liver Abscesses in Patients With Chronic Granulomatous Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The primary objective of this study is to determine the safety ofradiofrequency ablation (RFA) in the treatment of liver abscesses insubjects with chronic granulomatous disease (CGD). [ Time Frame: Throughout ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine if RFA is a reasonable treatment option for patients with liver abscesses who are not suitable candidates for completely curative hepatic surgery [ Time Frame: Throughout ] [ Designated as safety issue: No ]
  • To compare the recovery outcomes of patients undergoing RFA versus historical controls for patients undergoing surgery for treatment of liver abscesses [ Time Frame: Throughout ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: January 2030
Estimated Primary Completion Date: January 2030 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RFA
All subjects enrolled onto this study will receive treatment of their liver abscess (es) by RFA ablation
Device: Cool-tip RF Ablation System
RFA therapy will be administered according to the instructions of the RFA device manufacturer.

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, and a growing body of literature supports this technique as a therapeutic option for patients with primary or metastatic hepatic malignancies. In vivo animal studies have also shown that this technique can also be used to treat infections. Insertion of the thermal energy delivery probe into an infected liver abscess destroys the bacteria while preserving surrounding tissue. Off-label use of RFA was successfully used to treat 22 abscesses in 4 patients with chronic granulomatous disease who had inoperable liver abscesses. The proposed clinical trial will specifically evaluate the feasibility, safety, and to a lesser extent, efficacy of RFA to treat liver abscesses in subjects with previously diagnosed chronic granulomatous disease. This will be a non-randomized case study conducted at the Clinical Center at the National Institutes of Health. One RFA device will be used. Ten subjects will be enrolled. If the method proves to be both feasible and safe, detailed analysis on efficacy will be performed. RFA eventually could play an important clinical role in patients with chronic granulomatous disease and liver abscesses that are not amenable to surgical management and are without other effective therapeutic options, or might otherwise be incompletely treated with surgical resection and debridement alone.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION/ELIGIBILITY CRITERIA:

A patient will be included if he or she meets all of the following criteria:

  1. Has documented chronic granulomatous disease
  2. Age 18 - 75
  3. Has a liver abscess infected with Staphylococcus aureus, 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.
  4. Is willing to return to NIH for imaging scans
  5. Is willing to undergo testing or procedures associated with this protocol
  6. 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:

  1. Positive results for toxin-producing bacteria obtained from liver biopsy in the pertinent abscess.
  2. Is a good candidate for liver-curative open surgical resection and does not refuse the surgery
  3. Is not a candidate for RFA therapy due to lesion size, location, and/or infection with a non staphylococcal bacteria.
  4. 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).
  5. Has a platelet count < 50,000/mm(3) which cannot be maintained despite platelet transfusions.
  6. If you are pregnant.
  7. 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851460

Contacts
Contact: Patricia L Littel, R.N. (301) 402-5964 plittel@cc.nih.gov
Contact: Elizabeth M Kang, M.D. (301) 402-7567 ekang@niaid.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Elizabeth M Kang, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01851460     History of Changes
Other Study ID Numbers: 130117, 13-I-0117
Study First Received: May 8, 2013
Last Updated: January 16, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Staphylococcus Infection
RFA
Hepatic
CGD

Additional relevant MeSH terms:
Granuloma
Granulomatous Disease, Chronic
Liver Abscess
Abdominal Abscess
Abscess
Digestive System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Infection
Leukocyte Disorders
Liver Diseases
Lymphatic Diseases
Lymphoproliferative Disorders
Pathologic Processes
Phagocyte Bactericidal Dysfunction
Suppuration

ClinicalTrials.gov processed this record on July 01, 2015