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Ablatherm® HIFU
About Ablatherm® HIFU
Overview of Ablatherm® HIFU
This therapy is available as a new therapeutic option for localized
prostate cancer with the advantages of a non-invasive treatment:
precise local treatment in one session, repeatable if necessary,
a low complication rate* and completed in an outpatient setting.
This treatment is recommended for patients with localized cancer
(stages T-1 and T-2) who are not candidates for a prostatectomy
(because of their age, their general state of being or an associated
disease), or patients who want an alternative to surgery or radiation.
Additionally, this treatment can be used for cure with patients
who have local recurrence after external beam radiation therapy
(EBRT) or "salvage" treatment.
Ablatherm® HIFU is presently being used in England, the
EU, Russia, South Korea, and other Asian countries. The Ablatherm® HIFU
is currently not available in the US where clinical trials are
underway.
* C. Chaussy, S. Thuroff - High Intensity Focused Ultrasound:
Complications and Adverse Events - Molecular Urology, 2000, Vol.
4, 3:183-7
A Brief History of Ablatherm® HIFU Development
In 1989, INSERM Unit U281(National Institute for Health and
Medical Research), the Urology service of the Edouard Herriot
Hospital Lyon, France, and EDAP Technomed joined efforts and
initiated a research project in France. This project sought to
develop an efficient and minimally invasive treatment for localized
prostate cancer (stages T1-T2). After ten years of development,
the Ablatherm® HIFU was CE marked (European approval) and
the FDA gave approval in the United States to conduct a clinical
study.
Today, thousands of prostate cancer patients have been treated
successfully in multiple European centres.
Ablatherm® HIFU is approved for marketing and distribution
in the EU, Canada, Russia, South Korea and Australia.
How is the Ablatherm® HIFU Treatment Performed?
Preparation
Treatments are performed as an outpatient procedure. The night
before the treatment the patient is given an enema for colorectal
preparation.
Procedure
The treatment is performed transrectally generally under spinal
or epidural anesthesia. A probe is placed in the rectum with
the patient lying in the right lateral position. This probe emits
a beam of high intensity convergent ultrasound. At the point
where the ultrasound waves are focused (focal point) the sudden
and intense absorption of the ultrasound beam creates a sudden
elevation of the temperature (to greater than 85°C), which
destroys the cells located in the targeted zone.
 The
targeted zone destroyed by each pulse is oval-shaped and measures
from 19 to 24mm in height, 1.7mm in width and 1.7mm in thickness.
By repeating the pulses, and moving the focal point, it is possible
to destroy the volume of the whole tumor (400 to 600 pulses are
generally done to treat the volume previously defined).
The treatment duration varies according to prostate volume (1
to 3 hours). Swelling of the prostate appears immediately after
the treatment and compresses the urethra. A temporary urinary
catheter is placed until the edema recedes (which takes generally
from 7-14 days, depending on the case).
(*) Approved in the European Union (CE marked), under investigation
in the US.
What Kind of Follow-up is Necessary After Ablatherm® HIFU
The patient is usually discharged the day of the treatment and
can return to a normal diet that evening. The urinary catheter
is generally removed 10 to 14 days after the session.
Prophylactic antibiotics may be prescribed following the treatment
for 1 to 4 weeks. PSA level measurements and the urinalyses are
performed regularly.
Possible complications include:
mild bleeding in the beginning of micturition, frequent and sometimes
urgent micturition, urine leakage on exertion, and elimination
of necrotic debris (these are usually transient and self-limited).
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