Fibroscan

[SteveHepC]

Does anyone know if Fibroscan has been approved for general use, of is it still being evaluated and tested?

I'm desperate for a good non-invasive test that shows fibrosis level.

[rivll]

Mt. Sinai Hospital in NYC has one-I believe Dr. Dietrich is the one to contact.

[Bali05]

Assessment of liver fibrosis:

A major difficulty in developing antifibrotic therapies is the lack of accurate and established techniques to estimate fibrosis regression in response to therapy. Liver biopsy has long been the gold standard for assessing staging, but has several limitations. First, biopsy is an invasive technique which has associated morbidity; pain occurs in 20% of patients and major complications (such as bleeding or hemobilia) in 0.5% [Cadranel et al. 2000]. The bleeding rate (0.5%) has not changed significantly in recent years, according to a large multicenter study from the HALT C trial sponsored by NIDDK-NIH [Seeff et al. 2010]. The primary factor that appeared to contribute to bleeding risk was platelet count rather qualitative factors such as operator experience, needle size or the use of ultrasound to localize the site. Second, the small size of the biopsy makes it prone to sampling variability [Bedossa et al. 2003]. Third, the interpretation of the histologic changes can be problematic with inter- and intra-observer variation [Regev et al. 2002]. On the other hand, at least some correlation between biopsy stage and outcomes has begun to emerge. In the NIH-HALT C cohort, a correlation was found between the Ishak fibrosis stage and clinical outcomes, the need for liver transplantation, and liver-related deaths in patients with chronic HCV. However, even in this study up to 25% of the biopsy samples were fragmented, which significantly diminished the ability to draw correlations between biopsy findings and clinical outcomes [Everhart et al. 2010].

The current focus in the field is to develop noninvasive techniques to assess fibrosis stage. Ongoing efforts include serum markers and imaging based on ultrasound, CT, and MRI. The goal is to develop tests with high specificity and sensitivity to estimate fibrosis and predict outcomes.

Class II and class I serum biomarkers:

Class II biomarkers are indirect methods using serum biochemical and/or hematological tests, and are based on the detection of common functional alterations in the liver. In contrast, class I biomarkers are associated with the process of fibrogenesis, and their presence in the serum is the result of the increased turnover of ECM. The clinical acceptance of these biomarkers is still low in the United States. Simple and readily available biomarkers have low accuracy in predicting liver fibrosis and more advanced markers have an unacceptable cost–benefit ratio. Thus, liver biopsy still remains the gold standard for diagnosis of fibrosis. Additional noninvasive alternatives are being developed, and their implementation will be essential to test antifibrotic drugs in clinical trials [Jarcuska et al. 2010].

Measures using combinations markers have comparable ranges of accuracies as the individual markers. The best-validated methods are Fibrotest (gamma-glutamyl transpeptidase [GGT], haptoglobin, bilirubin, apolipoprotein A1, alpha-2-macroglobulin) and enhanced liver fibrosis test (ELF) (N-terminal propeptide of collagen type III, hyaluronic acid, TIMP-1, age). Recent data indicate that the results from these serum tests may be more accurate than biopsy findings in predicting risk of decompensation, survival without HCV-related complications and overall survival [Mayo et al. 2008; Ngo et al. 2006].

Imaging techniques:

Major advances in imaging technologies enable better detection of fibrosis. Transient elastography (FibroScan) is the most widely used noninvasive method for assessing the degree of liver fibrosis in Europe [Sandrin et al. 2003]. The technology is based on pulse-echo ultrasound to obtain liver stiffness measurements (LSM). It is rapid, noninvasive, reproducible, and acquires information from a much larger portion of the tissue than liver biopsy; therefore, the risk of sampling error is significantly lower. Transient elastography best distinguishes between stages at either end of the fibrosis spectrum. Its utility is limited, however, in patients with narrow intercostal spaces or morbid obesity. The stiffness may also be elevated in patients with acute hepatitis, probably reflecting edema and inflammation rather than fibrosis [Arena et al. 2008]. Using the combination of clinical variables of donor age and bilirubin with LSM has proven to be an effective strategy to estimate fibrosis progression rate, and to distinguish between rapid and slow fibrosers after liver transplant patients with recurrent HCV [Carrion et al. 2010]. Most recently, liver stiffness values as well as FibroTest have been more closely correlated with risk of decompensation over 5 years than liver biopsy [Vergniol et al. 2011] Recently a combination of FibroMeter and Fibroscan has provided a new classification for the noninvasive staging of liver fibrosis in patients with chronic HCV [Boursier et al. 2011]. This is similar to the Lok score in which liver stiffness is combined into a noninvasive algorithm for the assessing the likelihood of esophageal varices in cirrhotic patients [Stefanescu et al. 2011].

Acoustic radiation force impulse (ARFI) imaging technology has been implemented as a method to assess liver fibrosis. Recent studies have shown excellent diagnostic accuracy in identifying significant fibrosis and cirrhosis in patients with various liver diseases [Friedrich-Rust et al. 2009]. The technology can be adapted to existing ultrasound devices, making it potentially more accessible than transient elastography.

New MRI-based technologies are also gaining interest: contrast-enhanced MRI, diffusion-weighted MRI, and magnetic resonance elastography [Talwalkar et al. 2008]. The advantages are their assessment of the entire liver parenchyma, lack of an acoustical window requirement, and operator independence. The disadvantages are their cost and time-consuming nature.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3187682/

[quayle]

Dainne it is still a fact that Biopsy is still the gold standard,And my Specialist uses every bit of information to make a diagnosis,goolge the phrase "problems with fibroscans",and see for yourself,I already have,and many of the site are from eminnant medical universities and bodies all over the world I wish the test
was proven to be the best,but it's not

[quayle]

My specialist runs the clinic for hundreds of people in south Queensland,I think he knows what he's talking about.

[Diana66]

Well, I did not have to pay for mine as it is covered by the Public System.

I do have a LIver Specialist which is world renowned and I truly trust his advice. I also have a relative working in Radiology and that is why I know that US will never be used to diagnose cirrhosis or the level of Fibrosis

Again, if you prefer to rely on a radiologist advice based on an ultrasound, suit yourself, but be fair to everyone else and do not mislead them as you do not have any evidence supporting what you said

[quayle]

Your wrong I paid $250 for mine like I said the public or the Private system will not cover the test that has been in Australia for 4 years why/ and again your wrong as there are quite a few signs of cirrhosis on the ultra sounds and the Dr.s reading those ultrasounds Can SEEE evidence of cirrhosis,in many ways,fibroscan,is a blind test that only a machine can gauge,google utrasounds and cirrhosis you wil find they can sorry your just plain wrong.

[Diana66]

And with all respect for Hector, in matter of diagnose, investigations or treatment I would rely on a Specialist advice. A Liver specialist

[Diana66]

So what is the Australian Public System covering? Or the private one. I am sure you have done your Fibroscan through the Public System  as I have done it as well here in New Zealand. Biopsy it is not necessary and to be honest I cannot really see how a biopsy will be better since it is only a reflection of one spot.

Since with the Fibroscan you do several readings and it is based on an average , it will give you far more chances to get an accurate picture of what is happening. From the 10 readings I had, couple of the were very high and a few very low. So probably I do have a few spots were the liver is scarred but as a whole it is not a cirrhotic liver. A biopsy from the spots with a high reading would have put me to cirrhosis. So I really find a non invasive method being far better.

Ultrasounds are really useless to ***** the level of fibrosis. According to US I was great and fine (figure that), where in fact the fibrosis is severe and had the hep C probably for many many years. So I prefer not to be caught in a sense of false security. Sure, I would love to pretend that my liver is great based on the CT scans and ultrasounds I had but that would not serve me

So just to understand: who recommend it you the Fibroscan and who the ultrasound.
Dr in Radiology has nothing to do with diagnosing liver disease.

[quayle]

Buy the way,The Australian Public health system,or the private health companies, niether will cover this procedure and it has been in use 4 years here,so that gives you some Idea of how much faith they put in it.

[quayle]

Have You had a fibroscan Dianee?

[quayle]

Because a fibroscam is blind vibration and an ultrasound is a visual site of your liver blood flow spleen texture and the Dr that had my ultra sound from a year earlier and every year before that had a comparison to go buy,the Fibroscam  Had registered me 21 five times over the severe cirrhosis number for Cirrhosis for a Fubro scam,ultra sound showed No Hypertention normal blood flow spleen was well defined and visable,No sign of nodulation,( a sign of cirrhosis)
and according to the fibroscam I should have had stage 4 cirrhosis,and don't tell me a Dr. of radiology has not seen a cirrhotic liver before,they've seen [plenty  my final diagnosis from a comparetive ultrasound from one done by the same people a year before was a slightly enlarged liver.Ask any medical professional,your liver shrinks with stage 4 cirrhosis not enlarges,read about them you will see they get false positives
that's how I know.I gave Hector all the information of the ultra sound and he said it was good,.

[Willy50]

Thank you for weighing in on this.

My understanding is that there is no one perfect method.  Each method has it's benefits.

A biopsy takes a miniscule amount of tissue and extrapolates that represents the liver in it's entirety.

My understanding is that a fibroscan can find areas (for example) that might show advanced damage or minimal damage.  If one took a biopsy from either of these areas one might get very different liver damage staging results.

In this way a fibroscan is superior, or in it's cost and lack of invasiveness.  I believe that it is true that there is both calibration sensitivity issues which can skew results.  Also the operator can also affect the scores, and perhaps even interpretation of the scores the machine gives.

In light of that, if one traveled and got tests from various machines with various operators, it might make the test less useful and accurate.

*Fibrosure*, a blood test is another such tools for evaluation.  In this case the blood is drawn, tested and scores run in an algorithm which approximates liver damage staging.  Therefore, since many of these scores fluxuate throughout the day, the end score may also.  Differing labs processing the tests can also vary.  

My liver panel blood was drawn at the same time as my fibrosure test, but the fibrosure test scores showed approximately a 10% higher ALT.

I don't think we should take any of these tests as absolute.  There is margin of error in all of them.  

willy

[stef2011]

by the way also being fat (bmi>27) is a big problem because stiffness and wave propagation is different, with bmi so high as 27 or very obese over 30 fibroscan readings cannot be done even by using XL probe

and this is surely a problem in US (maybe the reason they dont use it) where obesity is so common while in europe and asia being less than bmi 23-25 is the majority of population and over bmi 27-30 rare

[stef2011]

it also matters the experienced doctor to read the fibroscan (not experinced doctors with fibroscan are useless) because the fibroscan detects stiffness which is the sum of fibrosis, inflammation and if present fatty liver, in case of advanced cirrhosis even nodules add some stiffness

once cirrhotic the fibroscan will register by monitoring the worsening of cirrhosis and its stages.

so in case of fatty liver or alt flares the reading is not correlated to the fibrosis only, any decent doctor know this when reading fibroscan results

[stef2011]

US is totally useless to see a cirrhosis, it just detects a destroyed liver with nodules which is a very advanced stage of cirrhosis, according to the patients end stage (not all cirrhotic livers go decompensated fast), early cirrhosis which is still reversable blocking the source of damage is totally missed by US and blood tests, not a single sign of it.i had it and no sings of it except the nodules of advanced cirrhosis and fibroscan, luckily it is all regressed to normal liver now except some small nodules

in case of any doubts a biopsy will rule out but biopsies are not used anymore in europe we have fibroscans since the early 2000, enough time to build statistics over thousands of patients

[Diana66]

I do not think that a simple ultrasound can can rule out the Fibroscan findings. If so they will base the diagnosis only on ultrasounds which obliviously it is not the case

I am not sure why would you believe more the findings of an ultrasound versus a fibroscan?

[quayle]

Steve DON"T BOTHER I Had one and it was 21 6points over the limit for total chirrosis,scarred the daylights out of me.After many ultrra sounds and one done after te Fibroscam (that's what they sould be called).NO CIRRHOSIS,NO PORTAL HYPERTENTION< NO NODULATION<NORMAL BLOOD FLOW,final diagnosis,slightly fatty liver,IT WAS WRONG.if you want to hear more just let me know

[orleans]

don't see what you're taliking about.

[apache1]

so the above correction goes in my first post right under
Only problem is the gray area.

so why is the forum editing me ???

apache

[apache1]

dont know why forum wont let me say this ???

less than four is no damage

over twelve is cirrhosis

[apache1]

wow, it wont let me post correction !
Lets try this

The way it was explained to me,

12 = cirrhosis

[apache1]

Sorry, this was suppose to be in the my last post.
Not sure why it did not post correctly.


The way it was explained to me,
12= cirrhosis

[apache1]

I got one done at Dr Schiff's office in the University of Miami liver center,

Dr Reddy did the Fibroscan and also was teaching a Hepatologist fellowship dr how to use Fibroscaner on me. Dr Reddy impressed me as being one of the most knowledgeable doctors I ever spoke with. Easy to talk to, aggressive treating, on the cutting edge hepatologist, imo.

It is a few minute painless procedure.
Although Dr spent about 25 minutes on me, explaining to his student how to place the probe properly and get an accurate reading and what the readings means on the screen.
All in all it was very interesting to me.

Only problem is the gray area.

The way it was explained to me,
12= cirrhosis

Anything in between is the gray area and could more or less go either way. He did say, readings over 18 are not good at all.

My score was 6.8

Fibroscan is not approved yet, but will probably tell you if you have cirrhosis or no damage, at least as good as the 'gold standard' harpoon bx 30% error rate.

apache

[SteveHepC]

I have a Mechanical Aortic Valve, am on blood thinners and the Doctors will not take a chance on a biopsy due to bleeding.