Fibroscan – A new tool in assessing chronic liver disease.

Liver disorders can vary from simple (uncomplicated) elevations in liver enzymes to advanced forms of cirrhosis [end stage liver disease].   Viral hepatitis (hepatitis B or C), alcoholic liver disease, and non-alcoholic fatty liver disease (NAFLD) are among the most common liver diseases seen in the outpatient setting.  Laboratory testing including serological (antibody) tests play an important part in evaluation of liver patients.  Ultrasound and cross sectional imaging (CT or MRI) are also useful in assessing for complications of chronic liver disorders.  For nearly a century liver biopsy has been used as an important tool in providing us information about the progression of liver disease and diagnosis of cirrhosis.  As physicians, our objective is to interfere with the progression of liver disease from simple steatosis (fat accumulation) to inflammation to early fibrosis (scarring) and eventual cirrhosis and liver failure.  However until recently, the only real means of assessing disease activity was a liver biopsy, with its associated risks and costs.  However with the approval of the Fibroscan by the FDA in 2013, physicians now have noninvasive tool for assessment of liver disease.

Fibroscan is a revolutionary diagnostic modality that can assess the elasticity of the liver by bouncing shear (sound) waves across the skin overlying the liver.  Fibroscan measures the velocity of these waves as they bounce off the liver.  The velocity of the shear wave correlates with the stiffness of the organ which reflects the degree of scarring (fibrosis) in the underlying liver.  The faster the wave travels the stiffer the organ. Thus a liver which has poor elasticity or sponginess tends to be firm (similar to a rock) and cirrhotic (with heavy scarring).  Fibroscan is a non-invasive, painless, inexpensive and rapid procedure that correlates well with findings of a liver biopsy in assessing for liver fibrosis (scarring).  Thus it has revolutionized the field of hepatology and provided patients an alternative to having a liver biopsy to determine the progression of their disease state.  Since the Fibroscan examination is brief and painless, it can easily be repeated on an annual basis to assess for liver fibrosis.  Hence it provides the physician an enhanced means of following the patient’s response to therapy or progression of disease.

Due to its ease of use, a larger proportion of patients with liver disease are being assessed for fibrosis, than previously with liver biopsies.  Most patients that have chronic viral or alcoholic hepatitis or fatty liver disease have never had a liver biopsy.  This is due to physician reluctance, patient fear and cost of the procedure.  However all of these patients can now readily be scanned with Fiboscan to determine whether they are showing signs of early fibrosis and need closer medical attention and treatment.  Being available in Europe and Asia, Fibroscan has instantly become a ‘routine’ procedure in the evaluation of chronic liver disorders in the U.S.

Fibroscan Examination –

  • The patient lies down on a stretcher looing up toward the ceiling.
  • The technician will apply a small amount of water based gel to right upper abdomen and place the probe with a slight pressure over the liver.
  • Ten consecutive measurements are made at the same location. The device will measure the state of the liver globally, as opposed to a biopsy where only a very small sample is measured.
  • The test takes about 10 minutes, and the quantitative results are delivered immediately.  The result is a number between 1.5 and 75 kPa (measure of resistance).
  • Fibroscan scoring is than correlated with the biopsy grading system F(0-4)

Electrical stimulation for management of reflux

Gastroesophageal reflux is believed to be due to prolonged or abnormal relaxation of the lower esophageal sphincter (LES).  Current pharmacological treatments for reflux are focused on suppression of gastric acid secretion rather the enhancement of LES function.  An electric stimulator device, similar to a cardiac pacemaker, was implanted under anesthesia in a subcutaneous pocket.  Two leads were attached to the LES to deliver electrical pulses to induce contractions in 30-minute sessions to coincide with peak periods of reflux events.  In the initial pilot study 24 patients with reflux were identified.  Most of these patients only had partial response to PPI therapy and showed elevated levels of esophageal acid exposure on 24 hour pH monitoring.  Both in short term and 12 month follow-up, investigators showed that none of the treated patients remained on daily PPI therapy and 77% of patients reported either normalization or significant reduction (>50%) in distal acid exposure over 24 hours.    There were no complications related to the implanted device or the electrical stimulation.  This technique may serve as a substitute for anti-reflux surgery in a select group of patients with reflux that are not adequately controlled with PPI use. [Rodriguez L, et al. Surgical Endoscopy, October 2012; DOI:10.1007/ s00464-012-2561-4]

Non-cardiac chest pain

Chest pain is one of the common causes of Emergency Room visits in the U.S.  The initial evaluation typically involves EKG and stress testing to rule out cardiac disease.  Equivocal test results lead to further studies including cardiac catherization.   However, most patients with chest pain do not have serious heart disease and are discharged from the hospital with a label of “non-cardiac” chest pain (NCCP) without a definitive diagnosis.

Once cardiac disease is ruled out, patients and physicians should entertain further evaluation of alternate sources of NCCP.  Nearly 35-40% of such patients have gastroesophageal reflux (GERD) as the cause of their pain with another 10-15% having other sources of esophageal disease that account for their chest symptoms.   While some of these patients have classic heartburn (consisting of burning sensation behind the breast bone), regurgitation, excess belching, or acidic taste in the throat, others do not have the typical symptoms of reflux disease.  Some patients have hypersensitivity of the esophagus resulting in chest pain even with non-painful esophageal stimuli.

Given the high propensity of GERD in patient with non-cardiac chest pain, the initial management of these patients involves a therapeutic trial with potent acid suppressant medications such as omeprazole and rabeprizole.  Resolution of chest symptoms with these medications is highly suggestive of underling acid reflux disease.  Lack of response may still indicate underling esophageal disease including hiatal hernia, paraesophageal hernia, non-reflux esophagits, or esophageal motilitiy disorder.  These conditions would require further evaluation including upper GI endoscopy and esophageal motility.

In spite of extensive evaluation, some patients with NCCP may never have structural abnormality or an organic disorder to account for their chest complaints.  Many of these patients have underlying anxiety, stress and psychiatric disorders that contribute to their symptoms.   They may benefit from low dose anti-anxiety or antidepressant medication in management of their symptoms.


Use of stents beyond heart disease

The use of stents for treatment of atherosclerotic disease of the heart has become popular in the past decade.  A recent recipient was the Prince Phillip of England  (Dec. 2011).   A stent is a small, hollow, plastic device inserted into the arteries of the heart in order to prevent the blood vessel from closing due to excess plaque.  Stents can be life saving devices as they maintain circulation (including oxygen and nutrient delivery) to the heart muscle.

Similarly larger stents can be used in the digestive tract to preserve patency (opening) of the esophageal or bowel lumen.  Esophageal stent placement involves the use of both endoscopy and fluoroscopy (x-ray).  Once the location of the esophageal narrowing is established, the physician is able to insert a long delivery apparatus through the mouth in order to deliver the stent at the point of narrowing or blockage in the esophagus.  Once the stent is deployed it expands within the esophageal lumen. This keeps the esophagus open in order to help the patient swallow or drink more easily. Esophageal stents are made of polyester (plastic), nitinol (metal) or hybrid material. These stents are typically used to treat patients suffering from advanced malignant (cancerous) disease.

Similarly, colonic stents are used for management of colorectal cancers.  Although these cancers are typically treated with surgery, in patients with advanced morbidity (with likelihood of surgical complication) or in patients needing preoperative chemo-radiation, colonic stents serve as a management option.  The insertion of colonic stents involves the use of an endoscopy (with fluoroscopic assistance). Once the stent is inserted through the endoscope and deployed, it expands to a diameter of 20mm.  This support structure remains in place permanently, relieving symptoms of blockage  which includes bloating, nausea, constipation and pain. These stents do not rust nor interfere with daily activity. Complications of colonoscopy are very rare but can include bleeding, perforation, infiltration of tumor (and recurrent blockage) and migration (stent movement).

What are the causes of rectal bleeding in adults?

Rectal bleeding is a common complaint among patients seeking care in a GI clinic.  Patient presentation can be quite variable.  There is also the concern that the underlying disease may be serious.  The vast majority of patients with isolated rectal bleeding (> 95%) have a benign disease process.   In younger patients (< age 40) with minimal bright red blood noted in the toilet or stool, we worry about the following problems:

1.  HEMORRHOIDS – Symptomatic (internal) hemorrhoids are perhaps the most common cause of bleeding in clinical practice.  These swollen blood vessels in the rectum can also be associated with anal discomfort, itching and protrusion.  The bleeding is typically bright red and typically coats the stool or drips in the toilet.  Some patients notice blood on the toilet paper.  Risk factors include underlying constipation, straining, pregnancy, long distance driving or cycling and hereditary factors.

2.  ANAL FISSURES – Bleeding from anal fissures is typically associated with sharp pain during defecation.  Fissures are tears in the lining of the anus and thus produce a sharp stabbing or tearing pain (and bleeding) during bowel movements.  They can be treated with topical anal cream but have a tendency to recure.

3.  PROCTITIS and INFLAMMITORY BOWEL DISEASE (IBD) that can cause rectal bleeding at any age.  Additional symptoms of this condition include loose frequent BMs and urgency to defecate.  Some patients can also have rectal/abdominal soreness and discomfort.

In older patients or those with significantly brisk bleeding we worry about the following issue:

4.   DIVERTICULOSIS – Diverticula are small out pocketing of the large intestine that are very common beyond age 50.   These herniated sacks usually do not cause symptoms.  However in older patients blood vessels that erode into these sacs can be a cause of profuse bleeding requiring hospitalization

5.   VASCULAR DISEASE – Abnormal vascular structures or diseases can be a source of bleeding in older patients.   These conditions include angiodysplasia, radiation colitis and ischemic colitis.  Although they do not typically produce profuse bleeding they can be associated with pain (in the case of colitis) or anemia (low blood count).

6.  COLON POLYPS AND CANCER  – Serious growths and tumors in the large intestine (colon) can occur at any age.  However the prevalence of these conditions tend to increase with age.   Clinical presentation of these patients is quite variable.  Some individuals are not even aware that they are losing small quantities of blood in their stool and are anemic upon presentation.  Obviously the diagnosis of such abnormalities should be made early in order to achieve the best clinical outcome.

The groupings of above diseases are based generalities and there are many exceptions (such as 32 year old patient with rectal cancer, or 76 year old patient with hemorrhoidal  bleeding)

All patients presenting with rectal bleeding to the clinic, irrespective of their age, need a physician evaluation including a digitial (finger) exam and a bedside scope test to evaluate the anus and rectum.  Some patients may need further evaluation of the colon including colonoscopy and laboratory testing.

Simple and inexpensive treatment of common digestive complaints.

Most common problems in the realm of gastrointestinal diseases are “functional” digestive disorders.  These ailments include Irritable Bowel syndrome, Dyspepsia, Functional Bloating and many of the bowel complaints commonly encountered in adults.  These conditions are not structural or pathological abnormalities that can be readily seen or diagnosed by endoscopy, x-rays or laboratory tests.   In contrast these disorders often arise from body’s altered response to external signals, food and stress.  Many of these patients have impairment that may be related to intestinal motility, hypersensitivity of the intestinal nervous system, or alterations in the mind-body signaling.  Much of these disorders are currently under intense medical research.  However effective pharmaceutical treatments are very scarce.   In contrast most of these conditions are readily manageable by common sense recommendations.   Effective implementation of the following lifestyle habits tends to be more useful than any prescription (or nonprescription) medications on the  market.

1. Stress reduction.

Excess stress can increase inflammation, increase indigestion and worsen existing digestive problems.   Stress reduction can be achieved through regular exercise, cultivating a support network, and developing a spiritual practice.   It is also important to get plenty of sleep, control anger & anxiety and consider pursuing innovative relation techniques.  For those with psychiatric problems seeing a therapist may also be helpful.

2. Improve diet

  • Eat more fiber – Most adults consume only about half the recommended dose of fiber (30 gm) on a daily basis.  Fiber in the form of fresh fruits, cereals, legumes and grains and oats facilitates regular BMs, regulates blood sugar level s and blood cholesterol.
  • Adopt a Mediterranean diet with intake of lean proteins, healthy fats (olive oil), anti-inflammatory fiber-rich whole grains.  Also limit carbohydrates and intake of highly processed foods.  If you need formal education consider seeing a dietitian.
  • Downsize meals.  Use a small plate to trick your senses into thinking you’re eating a plateful of food.  Eat until you feel almost full.
  • Chew food well and eat mindfully.  Rather than rushing through a meal take time to appreciate the food noticing its color, aroma and texture.  Be thankful for natures harvest.  Chew food well to activate the enzymes to breakdown foodstuff and provide time for stomach to digest nutrients
  • Try an elimination diet.  Many people have maldigestion as a result of lactose (dairy) intolerance, fructose intolerance or gluten (wheat) sensitivity.  It may be useful to keep a food diary for several days to determine correlation of digestive symptoms with specific foods.   Elimination of suspected food for periods of 2-3 weeks may be informative.


3. Change undesirable habits (for all the obvious reasons)

  • Stop smoking and using illicit drugs
  • Discontinue or curtail alcohol use
  • Minimize or avoid caffeine intake
  • EXERCISE regularly at least three times a week
  • Maintain ideal body weight

Emergence of Accountable Care Organization (ACOs) in Healthcare


Key part of the 2010 Health Care Reform has been the development of Accountable Care Organizations (ACO) which is planning to go into effect on Jan. 1, 2012.  These entities will eventually oversee the clinical care and financing for health care in the near future.  They will ultimately be accountable to the payers and will assume the risk of cost and quality of care.  The federal statues outline various requirements that are necessary for organizations to become ACOs.  CMS recently issued proposed regulation on March 31, 2011, to guide the development of ACOs that will contract with Medicare.   Large hospitals systems with strong physician networks will be in good position to become ACOs in the near future.  Similarly large PCP practices (or IPAs with numerous primary care physicians in a community), working with specialist and hospitals may develop the infrastructures to form ACOs in metropolitan centers.  Independent physicians or subspecialists will need to form alliances with regional ACOs in order to take advantage of this healthcare delivery system of the future.  Physicians can participate with several ACOs within a community.

Since ACOs are likely to be led by hospital or primary care groups, subspecialists will need to find innovative ways in working and negotiating with these entities.   Perhaps they will be asked to show quality metric measurements and implementation of cost effective practice guidelines in their practices.  For example gastroenterologists may be given “carve outs” for key illnesses, that they will be responsible for in their entirety.   This may include management of patients with Crohn’s disease, cirrhosis, or irritable bowel syndrome.  Hence the gastroenterologist would not only diagnose, treat and manage patient during an acute flare-up, but would also continue to be responsible for patient’s specific GI disease for the duration of his life.  Obviously this takes considerable knowledge about the cost of such care including costs of medications and being proactive in minimizing flare-ups and hospitalizations.  Since this is not a fee-for-service model, the GI practice will be rewarded by keeping patients healthy and avoiding expensive care and intervention.

Further reading:

Summary of CMS Proposal:


Medical food for treatment of hemorrhoids


Symptomatic hemorrhoids are among the most complaints in adult patients.  Nearly 50% of the population tends to have hemorrhoid trouble during their life time.  Most common symptoms include bleeding, itching, pain and prolapse.  Conservative (non-invasive) measures in management of hemorrhoids include high fiber diet, adequate fluid intake, sitz baths and topical anal creams (typically consisting of steroids).    Although there are numerous oral medications, and herbals that are marketed for management of hemorrhoidal disease, most of these agents have no proven track record.  An exception to this may be a medication called Diasmon.   This is a flavonoid fraction, a plant secondary metabolite.  Due to lack of any significant side effects, Diosmin is listed by the FDA in the Generealy Regarded As Safe (GRAS) category.   The active ingredient is non-toxic and safe without any know cross reactivity with other compounds.  Rather than a prescription medication, Diosmin is categorized as a medical food and is intended to be used under medical supervision for a specific medical disorder.

Diosmin has been studied in numerous clinical trials over the past twenty years.  It’s mechanism of action is in minimizing chronic venous insufficiency by improving venous tone and suppressing local inflammatory response in veins.  Micronized diosmin, marketed as Daflon has been used extensively in Europe.  In addition to hemorrhoids this compound has also been utilized in the treatment of varicose veins.

As a single agent for the treatment of hemorrhoids, Godeberge (1) showed that diosmin significantly decreased (50%) acute and chronic symptoms of internal hemorrhoids including anal bleeding, pruritus, and edema over a two month treatment period.   In a separate study by Ho (2), there was no significant difference in the treatment of Grade 1 small internal hemorrhoids using diosmin versus rubber band ligation.  However in larger hemorrhoids Yuksel (3) showed that schlerotheapy was more effective than diosmin alone.  Use of diosmin as an adjunct to conservative post-op care from hemorrhoidectomy was studied by La Torre (4).  This study showed that a disomin significantly decreased pain, tenesmus, and bleeding in the post-operative phase of recovery in the first two months after surgery.   Hence, diosmin may be used both in conjunction with conservative therapy for hemorrhoids or as an adjunct to more invasive intervention.  Currently, this medical food can be purchased as a micronized tablet supplement or as brand name Vasculera, which is component of Analpram Advanced Kit containing 2.5% hydrocortisone anal cream.



1) Goldberg, P. Daflon 500 mg in the Treatment of Hemorrhoidal Disease:  A deomastrated Efficacy in Comparison with Placebo.  Angiology 1994; 45-574

2) Ho YH et. al.  Micronized Purified Flavonidic Fraction compared Favorably with Rubber Band Ligation and Fiber Alone in the Management of bleeding hemorrhoids. Dis Colon Rectum 2000; 43-66

3) Yuksel BC, et al Conservative Management of Hemorrhods:  A cComparison of Venotonic Flavonidic fraction to reduce bleeding after haemorrhoidectomy. Br J Surgery 1995; 82:1034.

4) La Torre, et. al.  Clinical Use of Micronized Purified Flavonoid Fraction for Treatment of Symptoms after Hemorrhoidectomy.  Results of a Randomized Controlled Clinical Trial.  Dis Colon Rectum  2004: 47-704

New era in Hepatitis C treatment


This month the FDA approved two new medications for the treatment of chronic HCV disease.  Boceprevir and Telaprevir are both protease inhibitors that block the replication of the HCV virus in the liver.  They are not approved as monotherapy but rather as adjunct treatment to the standard (established) regimen of PEG-interferon and ribovarin.

Both Boceprevir and Telaprevir have been shown to significantly improve cure rates in the most common and difficult to treat group of patients (that have genotype 1 virus).  Typical eradication rates for genotype 1 chronic HVC disease, using 48 weeks of standard therapy are 45%.   The newer agents have been shown to improve this eradication rate to nearly 65-70% with just 24 weeks of treatment.  In patients that have never been treated with antiviral agents, cure rates with triple therapy including Telaprevir may be higher than 80%.   Although response rates in the black population is typically lower with antiviral agents, the use of triple therapy with Boceprevir increased cure rates in one study from 23 to 50%.   Similar improvements were seen, when patient that were previously nonresponders or partial responders to standard therapy, were subject to triple therapy.

Although  the recent data and FDA approval of these protease inhibitors improves the outlook for patients with  chronic HCV disease there are several issues that are of concern.   The triple regimens mentioned above come with significant side effects including flu-like symptoms, headaches, fatigue, depression, anemia and rash.   In the case of Boceprevir over 40% of patients required injectable erythropeitin to manage symptoms of anemia.  In the case of Telaprevir more than 50% of patients developed a skin rash with 7% of patients discontinuing therapy.  Furthermore there is concern that a proportion of previously treated patients (nonresponders) that are exposed to protease inhibitors may develop resistance –associated mutant variants.

As physicians develop programs to improve compliance and effectively manage adverse side effects, the new triple therapy with PEG interferon, ribovarin and a protease inhibitor is likely to become the standard treatment for HCV (genotype 1 ) disease.



McHutchinson JG et. al. Telaprevir with Peginterferon and Ribovarin for chronic HCV genotype 1 infection. NEJM 2009 Apr 30; 360-1827

McHutchinson JG et. al. Telaprevir for previously treated chronic HCV infection. NEJM 2010 Apr 8; 362-1292

Poordad F et. al. Boceprevir for untreated chronic HCV genotype 1 infection.  NEJM 2011  Mar 31; 364-1195

Bacon BR et. al. Boceprevir for previoulsy treatd chroinc HCV genotype 1 infection. NEJM 2011  Mar 31; 364-1207

Jensen DM, A new era of hepatitis C therapy begins. NEJM 2011  Mar 31; 364-1272



What is the cost of colonoscopy?

Colonoscopy is considered the gold standard in the anatomical evaluation of the large intestine.  Many patients ask whether a colonoscopy procedure is covered by their health insurance and cost of the procedure (in the case of those patients that have high deductibles and end up paying for this test out-of-pocket).

There are two types of colonoscopies;

  1. Screening colonoscopies is performed in patients (typically over the age of 50) that have no symptoms (no complaints).  This procedure is routinely recommended for early diagnosis of polyps and colon cancer.
  2. Diagnostic colonoscopy is performed in patients with specific complaints such as rectal bleeding, change in BMs, weight loss of unexplained nature and abdominal pain.

Since the year 2000, most commercial insurance companies and Medicare has covered the expense of screening colonoscopy.   In fact some insurance companies such as Blue Cross and Blue Shield (BCBS) will typically pay the entire cost of the procedure except for small co-pay ($25-50) which the patient is responsible.    The cost of diagnostic colonoscopy is typically covered by insurance companies once the patient’s deductible is met.   For example a patient with a deductible of $2,000 per year may have to pay the entire cost of the procedure out of pocket, if they have not met this deductible earlier in the year.

The cost (reimbursement) of colonoscopy is typically negotiated between the provider (physician’s office) and the health insurance company.   The complete expense of this test consists of the following components;

  1. Facility fee (for the use of the Endoscopy Center and instruments)
  2. Physician fee for performing the actual examination procedure
  3. Anesthesia fee for sedation provided during the procedure

There is also the pathology fee if there is any removal of tissue or polyps

The 2011 Medicare cost of colonoscopy with biopsy (CPT  45380) in Raleigh-Durham area are as follows:

  1. Facility fee          $ 362
  2. Physician fee      $ 277
  3. Anesthesia fee   $ 127

Pathology Fee (per specimen)   $ 112

The cost of colonoscopy services for commercially insured patients can be 40-60% higher than Medicare.   The patients should check with their insurance companies regarding their specifics coverage.

Additional useful information for Medicare patients (effective Jan 2011)