Download mr guided laser ablation informed consent

MR GUIDED LASER ABLATION INFORMED CONSENT
Definition
Laser ablation of the prostate gland is a minimally-invasive alternative to active
surveillance, radical prostatectomy, radiation therapy and brachytherapy for the treatment
of prostate cancer. It is a targeted procedure that focuses on a single area of tumor as
opposed to whole-gland therapy. For the procedure a laser applicator is introduced under
MRI-guidance via the rectum. Once in the gland, a non-therapeutic “test” dose is
administered to verify proper placement in the target, then turned up while the doctor
observes activity “real time” on a thermal map. Once the entire area is treated (1-2
minutes), the laser is turned off. One or more ablations may be performed depending on
the size, number or shape of the target lesion(s). Although animal and human research
indicate that laser prostate ablation is effective and safe, we still do not know the long term
effects and success rate of this procedure and its role in the treatment of prostate cancer
remains under active investigation. You will be asked to sign a second request form to allow
us to gather data about your medical condition after this treatment.
Preparation
The procedure cannot be done if you are currently on or have recently taken any
medication that may interfere with your ability to clot your blood (“blood thinners”). We will
have reviewed all of your current medications with you during the consultation, but please
tell us if anything has changed since your previous visit. We need to make sure that your
medication is not a blood thinner. The most common of these medications are aspirin and
all related pain reliever or anti-inflammatory compounds (whether prescription or over-thecounter).
You do not have to fast in order to have a prostate focal ablation. It is recommended that
you eat a very light breakfast (if your procedure is in the morning), or a very light lunch (if
your procedure is in the afternoon). Try, however, to eat at least 1 hour prior to the
appointment. If you have diabetes, make sure that you do not miss your regular meal.
You will be asked to take two adult fleet enemas. These should be administered 1-2 hours
before you leave for your appointment with our office.
You will be given antibiotic tablets as well. They should be taken as directed by our
physicians.
Have a friend or family member come with you that day to keep you company and drive
you home. This is especially important since you will receive conscious sedation.
The procedure cannot be done if you are currently on or have recently taken any
medication that may interfere with your ability to clot your blood (“blood thinners”). We will
have reviewed all of your current medications with you during the consultation, but please
tell us if anything has changed since your previous visit. We need to make sure that your
medication is not a blood thinner. The most common of these medications are aspirin and
all related pain reliever or anti-inflammatory compounds (whether prescription or over-thecounter).
You should fast in order to have a prostate focal ablation. Do not eat after midnight but
take your regular medications in the morning with only water. If you have diabetes, do not
take your morning insulin dose/
You will be asked to take two adult fleet enemas. These should be administered 1-2 hours
before you leave for your appointment with our office.
You will be given antibiotic tablets as well. They should be taken as directed by our
physicians.
Have a friend or family member come with you that day to keep you company and drive
you home. This is especially important since you will receive conscious sedation.
Procedure
The actual procedure typically takes 1-2 hours. You will be given an IV sedative medication
before and during the procedure. You will be placed lying face down on the MRI table. A
laser guide will be gently placed in your rectum. Although it is slightly uncomfortable, very
few patients believe it is painful. After confirming the precise position of the small laser
applicator with MRI, we will then treat the target area. Again, while most admit it is
uncomfortable, very few claim that it is actually painful. The amount of time the laser is on
will depend on the decision of your radiologist, your anatomy, and possibly on whether you
have had a therapy done in the past.
Post Procedure
After the procedure, you might feel a bit sore in the rectal or anal area for a few hours. We
rarely hear of problems beyond that, although patients with hemorrhoids might have
discomfort a bit longer. It is very common to see some blood from the rectum, on the stool
with the next bowl movement, or on the toilet paper especially that day and rarely the next
day. Again, this is more common in patients with hemorrhoids. A small amount of blood in
the urine or some discoloration of the urine is rarely seen but not impossible. You may
commonly see blood in your semen (ejaculation) for 1-2 days and sometimes up to 3-4
weeks. It might be red or just discolor your semen brown.
You are restricted from driving immediately following the treatment. You have no other
restrictions after the procedure other than to take it easy that day. Have a family member
or friend drive you home following the procedure. At the discretion of your radiologist, you
may go home with a urinary catheter in place. This is temporary.
Possible Complications of the Procedure
All procedures, regardless of complexity or time, can be associated with unforeseen
problems. They may be immediate or even quite delayed in presentation. While we have
discussed these and possibly others in your consultation, we would like you to have a list so
that you may ask questions if you are still concerned. Aside from anesthesia complications,
it is important that every patient be made aware of all possible outcomes which may
include, but are not limited to:
Excessive Bleeding from the Rectum/Anus: It is uncommon to require any treatment,
and the majority of the time bleeding stops on its own. This is far more common in patients
with hemorrhoids.
Blood Clots in the Urine: The device can enter the middle of the prostate where the
urethra or the neck of the bladder are located and cause blood in the urine. If the bleeding
is significant, it can cause clots that can block the urine flow. A urinary catheter may need
to be inserted to flush out the clots.
Urinary Retention: Even in the absence of bleeding, the prostate can become swollen
from the treatment or secondary to infection. In this instance, a catheter will be placed and
your doctor will discuss the next step. Usually, the problem resolves with time after the
swelling goes down. Sometimes, medications are given that may help to open the prostate
channel. Patients at greater risk are those who already have difficulty urinating before the
procedure due to BPH (Benign Prostatic Hyperplasia).
Urinary Tract Infection or Urosepsis: Although we give you antibiotics, it is possible for
you to get an infection. It might be a simple bladder infection that presents with symptoms
of burning urination, urinary frequency and a strong urge to urinate. This will usually
resolve in a few days with antibiotics. If the infection enters the bloodstream, you may feel
very ill. This type of infection often presents with the urinary symptoms and any
combination of the following: fevers, shaking, chills, weakness or dizziness, nausea and
vomiting. You may need a short hospitalization for intravenous antibiotics, fluids, and
observation. This is more common in diabetics, patients on long-term steroids, or patients
with any disorder of the immune system. Lastly, an abscess of the prostate, while quite
rare, can develop. This is an infection cavity that may respond to antibiotics alone or need
surgical (needle) drainage. It can begin with urinary symptoms but also progress to the
symptoms of bloodstream infection. Urinary retention is possible with an abscess.
this procedure in less than 10% of patients. This condition may be temporary or
permanent.
ly control urination may be lost in less than
5% of men undergoing this procedure. This may be a temporary or permanent condition.
the procedure. This condition usually resolves over weeks to months.
urinary bladder may develop. This may require surgery for treatment.
here is improved survival
after ten years following whole-gland definitive therapy (radical prostatectomy, radiation
therapy) compared with active surveillance (watchful waiting) for the treatment of prostate
cancer confined to the prostate gland. No similar studies currently exist confirming
improved survival following laser focal ablation of the prostate gland for prostate cancer.
If you have symptoms of any of the above, especially those of infection, you
must contact the office of Dr. Eric Walser immediately or go to the nearest
emergency room.
We provide this literature for patients and family members. It is intended to be an
educational supplement that highlights some of the important points of what has been
previously discussed in the office. Alternative treatments, the purpose of the
procedure/laser ablation, and the points in this handout have been covered in our face-toface consultation(s).
By signing this Informed Consent, I agree to have magnetic resonance thermal imageguided laser-induced interstitial thermal therapy for focal ablation of prostate cancer.
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Physician
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Patient
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