| |
A Real-life Fantastic Voyage
Irene Burgo
 A
new, cutting-edge medical technology is revolutionizing the treatment
of gastrointestinal disorders. It’s called the “capsule endoscope”
and the technology has linked three Villanova alumni involved with its
use. In fact, you might say the capsule endoscope has launched them on
a real-life fantastic voyage. Scott D. Fraser, ’93 C&F, Dr.
Edward V. Loftus ’84 A&S and Dr. Christopher Gostout ’76
A&S, didn’t cross paths at Villanova. A serendipitous encounter
with this innovative technology made by Given Imaging, Inc., connected
them a few years ago when the company launched its “capsule endoscope.”
The capsule endoscope is in fact a capsule pill, containing a miniature
camera that is used to perform endoscopies in a non-traditional way. (In
the traditional endoscopy, the physican threads a tube down the patient’s
esaphagus to examine the small intestine.) In the new non-invasive procedure,
patients simply swallow a large vitamin-sized capsule. The miniature camera
within takes images of the patient’s digestive system as it travels
through the patient’s gastro-intestinal system. While traveling
on a real-life fantastic voyage, the capsule records thousands of images
and data that get transmitted into video format. A belt pack containing
software that receives and converts the data from the capsule into video
format is worn by the patient around his or her waist. The procedure takes
about eight hours to complete. Once the data is formatted, the physician
then reads the results by reviewing the video on a computer screen. Since
the product’s launch in this country in 2000, the three Villanova
alumni have been exploring the possibilities of this progressive new medical
tool.
Fraser ’93, who is the director of marketing for Given, is responsible
for introducing the capsule endoscope to potential clients worldwide.
Given, an Israeli-based company which makes only the camera pill, has
already distributed it in more than 40 countries. It was Fraser who introduced
the innovative technology to Loftus and Gostout, who are both based at
the Mayo Clinic in Rochester, Minnesota.
The capsule endoscope is (see photo on this page) used primarily to diagnose
diseases of the small intestine. This camera pill was invented by a former
Israeli missile designer, named Gavriel Meron, who is president and chief
executive officer of Given. The technology is based on an Israeli-designed
missile used in the Persian Gulf War. Fantastic but true.
According to an article in Modern Healthcare’s February 2003, since
the
Capsule endoscope was cleared for the U.S. market in August 2001, it literally
has been swallowed up by patients and physicians alike. In an interview
for Villanova Magazine, Drs. Gostout and Loftus discussed why the capsule
endoscope is getting such rave reviews.
Two Villanova physicians at May Clinic
Dr. Edward Loftus, who graduated from the College of Arts and Sciences
with a major in biology, is a consultant for gastroenterology and hepatology,
specializing in inflammatory bowel disease (IBD), at the Mayo Clinic in
Rochester, Minnesota. He’s also an associate professor of medicine
at the Mayo Medical School and at Mayo Clinic. He has been using the capsule
endoscope in his research on IBD. The two main inflammatory bowel diseases
are Crohn’s disease and ulcerative colitis. The capsule can be useful
in identifying variants of inflammatory bowel disease such as microscopic
colitis, a term encompassing two conditions: collagen us colitis and lymphocytic
colitis, according to Loftus. To better understand how the capsule endoscope
can identify these problems, Loftus has designed a protocol and is currently
conducting a study comparing the capsule endoscope’s accuracy to
standard techniques.
 Gostout,
who also graduated from the College of Arts and Sciences with a major
in biology, is a professional endoscopist, specializing in endoscopic
techniques, who heads the Mayo Clinic’s Developmental Endoscopy
Unit. The only one of its kind in the country, the Unit was designed to
advance the field of endoscopy. Researchers there seek new ways to treat
patients with the endoscope. Gostout spends his day performing various
endoscopic procedures. That’s how Gostout became involved with the
capsule endoscope. “Most of what I do is therapeutic as opposed
to diagnostic,” said Gostout. “When a patient is sent to be,
they have a problem that needs to be fixed. They may have a tumor that
needs to be removed, heartburn that needs remedying, or bleeding problems
that it is presumed may be handled with an endoscope.”
Gostout also is president of the American Society for Gastrointestinal
Endoscopy this year. As one of his major initiatives in that capacity,
he developed a series training courses for physicians in the use of the
capsule endoscopy.
The capsule endoscope is part of Given Imaging’s Diagnostic System.
It consists of a diagnostic tool—the capsule--for imaging the small
intestine. Normally, this part of the small bowel cannot be reached by
the traditional procedures known as upper endoscopy or by colonoscopy.
Given promotes its technology as non-invasive, easy to perform, with results
that provide a substantially improved level of visual imaging for early
detection and diagnosis of the gastrointestinal tract. (See sidebar for
description of Given Imaging’s Diagnostic System.)
So far, the capsule endoscope has proven to be a breakthrough tool for
doctors, especially gastroenterologists who diagnose GI symptoms. “The
capsule pill is truly the newest technology to impact the field of endoscopy,”
said Dr. Gostout. “There is no doubt about it. There has been nothing
for the past 10 years that has been as dramatic as the capsule endoscope.”
The device is referred to as the camera pill, or cam pill, but its official
name is the “capsule endoscope.” It is the size of a very
large vitamin and it contains a miniature camera capable of taking about
55,000 useful images once the patient swallows it with some water. (Given
claims that overall the capsule is capable of recording 66,000 images.)
The capsule endoscope is already being widely used to diagnose patients
who suffer with persistent gastrointestinal symptoms.
There is no doubt about Gostout’s enthusiasm for the technology.
The physician has used capsule endoscopy since the fall of 2001 when the
Mayo Clinic acquired it. “We immediately started to do an investigative
study using the capsule to see how well it would work in patients who
have unexplained gastrointestinal bleeding,” he said.
In fact, Gostout was one of the first physicians in the 1980s who researched
methods for examining the small intestine using an endoscope. “This
[endoscopy] was such a difficult task, not only for the physician performing
the examination. It was very difficult and stressful for the patient as
well.” In addition to being a non-invasive procedure, the benefit
of this technology is that it allows physicians to image the small intestine.
Previously, this was an area of the digestive system that could not be
reached by the standard tests like colonoscopy or upper endoscopy.
In endoscopic procedures, the physician threads the scope into the patient’s
gastrointestinal system and monitors its progress through a video screen
with miniature instruments that go through the endoscope to the target
area.
The traditional methods previously used to examine as much as possible
of the small intestine were inconclusive and uncomfortable. They included
the Sonde endoscope as well as another, longer scope, called the “push
enterescope, according to Loftus. With the Sonde method, patients had
to swallow an instrument about 5 millimeters in diameter and about 12
feet long. “It’s very difficult and uncomfortable for the
patients. It’s like trying to push a piece of spaghetti into a pipe.
It’s done under sedation, and it only gives you an extra three of
four feet of visualization of the small intestine. So, there’s still
a large portion that the doctor cannot see. That’s where the capsule
really adds a whole other dimension to diagnosis here, in the small intestine.”
The most common reason for doing the capsule endoscopy is to explore the
cause of unexplained bleeding from the small intestine. The procedure
also is valuable in diagnosing patients with suspected inflammatory bowel
disease (Crohn’s disease), polyps ulcers and tumors of the small
intestine. Before the capsule, doctors found it difficult to diagnose
patients whose symptoms could not be alleviated or diagnosed by results
from standard testing such as colonoscopy or upper endoscopy. Patients
whose symptoms were severe or who had continued intestinal bleeding were
forced to undergo even more uncomfortable invasive testing, including
scopes of the lower intestine known as asenteroscopes, which deliver only
a partial image; or fuzzy cat scans.
Imagine you visit your doctor complaining of gastrointestinal symptoms.
You might be suffering GI symptoms such as recurrent abdominal pain, bloating
and chronic diarrhea. Perhaps you have undergone multiple, uncomfortable,
invasive tests that have yielded no results and no conclusive diagnosis.
Despite extensive testing, your doctor has not been able to diagnose or
help you manage your symptoms. With no course conclusive results or treatment,
your symptoms continue. As an alternative, your physician suggests exploratory
surgery. This type of surgery is extremely invasive and requires a minimum
of six-weeks of recuperation.
Typically, doctors prescribe a standard course of testing for patients
with unexplained bleeding in the GI system. These tests include a colonoscopy,
upper endoscopy plus a follow-up exam called a barium X-ray. If the colonoscopy
and upper endoscopy yield no results, then the patient is given the barium
X-ray. Sometimes the doctor will order various scans of the abdomen. Before
the capsule endoscope, the barium X-ray was the only way, short of surgery,
to image part of the small intestine.
Also, before the capsule endoscope, there was no way for doctors to fully
image the small intestine. “The small intestine or small bowel is
the part of the intestine that’s collapsed onto each other,”
said Fraser. “Colonoscopy views about a six-foot section. Upper
endoscopy views the first portion from the esophagus down to your stomach,
to the beginning of the small intestine. So, until now, the area of the
small bowel was considered the black box of medicine.” Exploratory
surgery was the only option for patients who continued to exhibit symptoms.
Unfortunately, this surgery was often the last resort, and it still is
highly undesirable for several reasons.
“Even with exploratory surgery, your yield of actually finding the
source of gastrointestinal bleeding is at best 40 to 50 percent,”
said Loftus. “Usually a gastroenterologist will examine the images
and try to find a bleeding blood vessel. Sometimes, blood vessels bleed
only intermittently. They [the source of the problem] might be no bleeding
during surgery. So, with exploratory surgery, you’re subjecting
a lot of people to full surgery, and yet you know, you weren’t even
solving the problem in half the cases.”
FDA Approval as front-line test
As the capsule endoscope becomes more widely used, patients will be able
to have this test first, in lieu of the more invasive GI tests. In July
of this year, the FDA approved it as the front-line diagnostic tool. This
is important stride because it allows physicians to make the judgment
to use the capsule first, over all of the existing methods that are available
to examine the small intestine.
“Previously, the FDA had approved capsule endoscopy for use very
exclusively, for trying to uncover the source of bleeding in patients
for whom it was not known what they were bleeding from,” said Gostout.
“This was after they had gone through examinations of the small
intestine involving a small intestinal X-ray. Now physicians can go straight
to the capsule endoscope to try to make a diagnosis. That’s a major,
major impact on how this instrument now will be used.”
Gostout feels strongly about the capsule’s benefits. “The
capsule has revolutionized our ability to look into the small intestine—and
not only for unexplained cases of bleeding from the intestine. It’s
expanding now to other patient groups like those who have inflammatory
diseases of the intestines, especially Crohn’s disease, which Dr.
Loftus studies, and which afflicts a much larger patient population.”
Some healthcare providers have approved the capsule endoscope as eligible
for reimbursement. Dr. Gostout feels that efficacy of the capsule will
not only save money for the healthcare providers but that it will encourage
them to approve the procedure more readily. “The cost-benefit ratio
will be in favor of doing capsule endoscope once they realize how well
this technology provides an answer over subjecting the patient to multiple
diagnostic studies.”
Case example
 Loftus
cited a case example of how the capsule endoscope successfully pinpointed
a problem that other tests had missed. A patient was being treated at
the inflammatory bowel disease clinic at the Mayo Clinic. “We suspected
Crohn’s disease in a patient, before we had our study up and running,”
he explained. “A woman came into the hospital with abdominal pain.
“She had all the tests—the colonoscopy, upper endoscopy, scans,
and the GI small bowel barium X-ray follow-through,” said Loftus.
“All of those tests didn’t show a cause, so we decided to
perform the capsule endoscopy. And low and behold, in the middle of her
small bowel, she had numerous small ulcers. We then did a blood test.
An antibody test called an ASCA test (which stands for antibodies to Saccharomyces),
a form of baker’s yeast. There are some patient’s with Crohn’s
disease who have a positive antibody. So, the fact that she had ulcers
in her small bowel and had this positive antibody made us suspect Crohn’s
disease. We initiated treatment and she got better. That’s the most
dramatic example I’ve seen where the capsule endoscope really did
solve the diagnostic dilemma.”
Capsule Risks
“The capsule is not perfect,” Loftus cautions. “In some
people you can’t find anything wrong [a cause to diagnose] even
with the capsule. That does happen, but at least it occurs in a non-invasive
way.”
Do patients experience complications with capsule endoscopy? In some instances,
the capsule has gotten stuck in the patient’s gastrointestinal tract.
“This has happened in actually .01 percent of patients—so
it’s one in a thousand.” Out of 26,500 capsule endoscopes
performed, about 28 got stuck. When it has gotten stuck, it’s often
gotten trapped at the source of the patient’s problem.. “The
interesting thing is that virtually all the people in whom the capsule
has gotten stuck, needed to go to surgery to have it removed. In all the
cases, the capsule was stuck at a point where there was a stricture or
narrowing of the small bowel and there was a tumor. So, even when the
capsule has gotten stuck, the patients have benefited because it had identified
an important clinical finding for the surgeon.” It takes a physician
about one hour to read the results from the video produced during the
capsule endoscope and make a diagnosis.
Even though it has received recent FDA approval, the capsule probably
won’t be widely used until both healthcare insurance providers settle
the reimbursement issue. According to the “Medical Healthcare”
article, “it could be years before community hospitals” adopt
the technology. Not all insurance companies are reimbursing for this procedure.
“The cost can be prohibitive,” observed Gostout. “ It
will take a while. If physicians aren’t going to get paid well enough
for their time and effort, they are not going to recommend it. And they’re
not going to embrace it, even though it may be phenomenal. That is a major
concern.”
Nevertheless, Gostout feels strongly about the capsule’s benefits.
“The capsule can save money and save unnecessary surgery in some
patients,” he said. “It allows you to make a diagnosis where
previously you couldn’t. It allows you to direct management to the
patient’s problem more precisely than you could before. It can reduce
unnecessary testing, and reduce unnecessary surgery. It also can create
more appropriate surgery by being more precise [in identifying the problem].
For the patient, it’s more convenient and more tolerable, and more
accurate for them as well. It gives them answers where before there was
no chance of any. “There are no equally effective alternatives for
what the capsule does.
“The capsule has revolutionized our ability to look into the small
intestine—not only for cases of unexplained bleeding from the intestine,
but it’s expanding to other patient groups,” added Gostout.
“Dr. Loftus’s research will eventually become very intimately
involved with one group of patients who have inflammatory diseases of
the intestines, especially Crohn’s disease.”
|
|
