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Radiofrequency Ablation for Liver Abscesses From Chronic Granulomatous Disease

NCT01851460 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-03-26

No results posted yet for this study

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.

Conditions

  • Chronic Granulomatous Diseases (CGD) and Liver Lesions

Interventions

DEVICE

Cool-tip RF Ablation System

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Elizabeth M Kang, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-08
Primary Completion
2020-03-24
Completion
2020-03-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01851460 on ClinicalTrials.gov