The low-tech barriers of this high-tech procedure.
Virtual colonoscopyusing such imaging techniques as CT or MRI
to visualize the bowel and screen for potentially troublesome polyps and lesionsis
gaining ground as a supplement or alternative to traditional optical colonoscopy. Virtual
colonoscopy has proven about 90% accurate in identifying potentially cancerous polyps of
10mm or more, making it an increasingly viable option to direct visualization with a
colonoscope.
With colonscopies, it is not the high-tech scanning equipment but the low-tech
bowel-prep procedure that is proving the biggest issue for patient acceptanceand
reimbursement issues and lack of training might deter physicians and imaging centers from
coming on board.
Techniques
In traditional colonoscopy, patients must complete a fairly harsh preparatory
procedure that combines fasting with use of a strong laxative, often polyethylene glycol,
to wash all fecal matter from the bowel, ensuring a clean visual field. The bowel is then
viewed by means of a video camera thats inserted via a flexible tube to the proximal
end of the bowel, then slowly extracted to allow the endoscopist to scan for polyps and
suspicious areas. Any questionable areas usually can be removed for biopsy in the same
procedure.
In contrast, virtual colonoscopy does not involve as much preparation or any invasion.
Patients consume a low-residue diet for up to 3 days prior to the exam and use a much
gentler laxative, often a citrate osmotic preparation, to clean the bowel of nearly all
fecal matter; a tagging agent is sometimes used to allow residual matter to appear clearly
on scans and be disregarded. The patients colon is then insufflated with either room
air or carbon dioxide, and a CT scan is taken with the patient in both prone and supine
positions. The resulting images can be manipulated by software to provide a variety of
views and to subtract the tagged fecal matter from the picture.
The conventional procedure will typically take an endoscopist 20 to 30 minutes to
perform, examining the bowel during the procedure. By contrast, virtual colonoscopy could
require 10 to 15 minutes to perform and then 10 to 15 minutes for a radiologist to read.
Some imaging centers might provide for on-site reads, while some might use the services of
a radiologist at a remote location, creating a wait for the results.
Virtual colonoscopy compares favorably with the conventional method in sensitivity of
detection of the sorts of polyps that could be the most problematic. For polyps 10mm or
greater, virtual colonoscopy shows a sensitivity of 90%. Even slightly smaller polyps are
picked up fairly easily. Seven- to 10-mm polyps, were very good at, says
Erik Paulson, professor of radiology and chief of the Abdominal Imaging Division for Duke
University (Durham, NC).
For still smaller polyps of 5mm or less, sensitivity drops off to as low as 50%,
according to data from the American Cancer Society (ACS) in Atlanta. This might not
present much of a problem, as the risk of malignancy decreases along with polyp size.
Smaller polyps are much more likely to be hyperplastic and are not likely to become
cancerous in the patients lifetime, according to the ACS. This finding is not an
excuse to be cavalier, however. Nothing good can come of a polyp, Paulson
says.
In addition to the lower level of accuracy in detecting smaller polyps, virtual
colonoscopy has the potential for incorrect readings, says Judy Yee, associate professor
of radiology for the University of California, San Francisco, and chief of CT and GI
radiology for the VA Medical Center. While residual stool and thick folds of bowel lining
and tissue can lead to a false positive, flat lesions and small lesions can be overlooked,
leading to a false negative, Yee says. The ACS adds that inaccurate results also can come
from diverticular disease and metal or motion artifacts, both of which can produce a false
positive.
Virtual colonoscopy has some notable advantages over the more traditional optical
method, says Jim Clayton, research analyst with Frost & Sullivan (San Antonio, Texas).
First among these is the noninvasive nature of the procedure. [There is] much less
chance of a perforated bowel, Clayton says. This risk is small but real in
conventional colonoscopy, according to Gregory Snyder, medical director for Minnesota
Radiology (Edina, Minn). With endoscopy, one in a thousand will have a ruptured
bowel, he says, adding that 10% to 15% of these conventional procedures will be
incomplete, translating to an overall success rate of just 85% to 90%. As a
screening exam, [conventional colonoscopy] doesnt make sense, Snyder adds,
extolling virtual colonoscopy as painless, no risk, no morbidity, and no
mortality.
But perhaps the most important advantage from the patient perspective is the bowel prep
procedure, which can be less harsh and conducted over a shorter period than that for
traditional colonoscopy. The biggest problem for conventional [colonoscopy],
Clayton says is the prep solution and time.
Preparation
[There are] neat new imaging technologies, but the biggest hurdle is low
tech: bowel prep, Paulson says. Conventional and virtual colonoscopy both depend
upon the bowel being free or mostly free of fecal matter, and it is this process of
cleaning the colon through laxatives and diet that most patients find unpleasant.
According to Snyder, this preparatory procedure is at the heart of patient acceptance.
He explains that the standard prep involves the patient ingesting approximately 2 gallons
of polyethylene glycol that literally washes fecal matter out of the bowel, a process that
patients often find unpleasant due to cramping and diarrhea.
But for virtual colonoscopy prep, Snyder uses products from E-Z-Em (Westbury, NY) that
make the preparation less harsh. Patients use a citrate laxative that is osmotic, so
ingestion of plenty of water helps to evacuate bowel contents. Then, a barium sulfate
stool tag product called Tagitol is used to help the residual fecal matter show up on
scans. Once fecal matter is tagged, it can be removed from the image by software programs
in a process known as electronic subtraction, or, less accurately, electronic cleansing.
This means that residual fecal matter presents less of a problem, allowing patients to
undergo less harsh but slightly less complete cleansing procedures prior to the exam.
Although physicians, and certainly patients, may hope for the day that virtual
colonoscopy can be performed without preparation, Snyder is not optimistic that this will
come. I dont know if well ever get to prepless, he says, noting
that insufflation is difficult with a fecal mass in the colon.
Insufflation is another issue where steps can be taken to make the procedure more
comfortable and attractive for the patient. Typically, the colon is insufflated with
either room air or carbon dioxide. While room air remains in the colon until the patient
passes it, carbon dioxide is absorbed into the bloodstream and released through
exhalation. Because of this difference, many patients prefer that carbon dioxide be used.
Automated insufflation equipment is available to help achieve maximum distention with
minimal discomfort.
Reimbursement
From a provider standpoint, the bigger issue is in obtaining insurance, says Snyder, who
estimates that, without insurance to defray costs, nine out of 10 patients
wont go through with [the procedure].
In general, virtual procedures typically cost around $750. And virtual colonoscopy
tends to be less expensive than the conventional procedure. It is this cost differential
that makes reimbursement a good deal for most insurers, and it is why Snyder expects to
see widespread reimbursement begin within a year. Its a no-brainer to sign up
for this, he says. However, some folks anticipate that insurers might see economic
advantage in moving deliberately. If a third-party payor can hold off for 6 to 12
months, [it] can save an awful lot of money [over that period], says Bryan
Westerman, clinical sciences manager for CT for Toshiba (Tokyo).
Training a Key Need
In addition to reimbursement, lack of training opportunities is a key factor limiting
radiologists acceptance of the procedure, says Abraham Dachman, professor of
radiology and director of CT for the University of Chicago and editor of the Atlas of
Virtual Colonoscopy (Springer Verlag, 2003). Theres a long learning
curve, Dachman says. Its difficult to learn to interpret [the]
examination; [it] takes a lot of skill. One difficulty arises in learning to view
both two- and three-dimensional images. Typically, virtual scans are read in 2D form to
identify suspicious areas, then a 3D image is used for closer examination. The 3D images
can also be used to create a flythrough that mimics the view seen during a
conventional procedure.
Opportunities for radiologists to develop this skill are still few and far between,
says Dachman, who explains that, currently, no organizations have guidelines mandating
frequency or content of training. Some institutions, such as the University of Chicago,
offer CME courses infrequently (Chicago offers courses four times a year), and some
manufacturers host periodic training sessions (Dachman teaches courses offered by
Waukesha, Wisbased GE Medical Systems). Only a handful of people teach
courses, Dachman says. Alternate means of gaining exposure include consulting books
like Dachmans or using software tutorials. However, the best way of gaining comfort
with reading virtual colonoscopy scans is to read practice cases and then compare the
results with those gained from a conventional read. As with many techniques, practice
builds accuracy.
Target Population
Virtual colonoscopy has certain benefits and advantages that could indicate the
best population for this procedure. On one hand, Frost & Sullivans Clayton
explains that if you find polyps or lesions greater than 10mm, you cant take a
closer look or remove them. If such an area is found, you put the patient
through two different procedures, he continues, by requiring the patient to return
for a conventional colonoscopy to examine and perhaps remove the suspicious area.
However, for normal people over 50 years [old] who want to take preventive
measures in their own hands, Clayton says that virtual colonoscopy might be an
attractive option. Paulson agrees and has identified four populations that are
particularly suited for virtual colonoscopy: those seeking a simple screening for polyps;
patients who have had a failed conventional colonoscopy and need to complete their
screening the same day without having to repeat bowel prep; patients with known colon
cancer whose tumor obstructs the bowel, preventing complete conventional screening; and
patients who particularly request the virtual procedure.
Outlook
The move to virtual colonoscopy for at least some patient screening could be a
matter of acceptance rather than technology. Many hospitals or imaging centers might
have the capabilities, but [theyre] not using [them], Clayton says. He
attributes this lacking to the need for adequate training as well as appropriate
reimbursement.
Additional research to determine the effectiveness of virtual colonoscopy for a
screening population could help both insurance companies and imaging centers to become
more comfortable with the procedure. Studies to date have been based on selected
patient groups, Paulson says. The efficacy in a screening population is
unknown. He adds that an ongoing study at Duke will be released within the next 3
years. In the meantime, Jacob Sosna and colleagues from Harvard Medical School (Boston)
have released a meta-analysis of virtual colonoscopy studies that confirms at least an 81%
sensitivity for polyps of more than 10mm.
More research might also indicate whether virtual colonoscopy will remain a CT
procedure, or whether MRI will be an alternate modality. [I have] not seen anybody
try this with MRI, Bryan Westerman says. The special resolution of CT makes it
the preferred modality, he says, adding that the speed helps CT handle the motility
of the bowel. MRI has gained greater acceptance in Europe, says the VA Medical
Centers Yee, who adds that there is more focus on radiation exposure in the
international market than in the United States. She explains that MRI colonoscopy lags far
behind the CT model in the United States due to a lack of research supporting its efficacy
and its higher cost.
Another option to reduce radiation exposure is ultralow-dose virtual colonoscopy.
At the 2003 European Congress of Radiology, Riccardo Iannaccone from the University of
Rome, La Sapienza, presented research results that compared same-day virtual low-dose and
conventional colonoscopies. Low-dose colonoscopy detected 100% of the carcinomas
identified by the conventional screening, and the procedure had an overall 89.1%
sensitivity in detecting polyps of 6mm or larger. However, the study also found reduced
ability to find extracolonic abnormalities due to lower contrast in such areas as the
liver and pancreas.
Improved data collection is also on the horizon. Data collection is probably
pretty good right now with 16-slice scanners, Westerman says. He adds, Toshiba
has a working prototype of a 256-slice machine. With dramatic increases in data
collection such as this, the medical community will need to reach consensus on cost versus
increased collection. There could be incremental changes that are very
expensive, he says.
Westerman also believes that hardware is less of a driver [than] data
handling. First among these data-handling methods is computer-aided detection (CAD),
a technique that already has found some uses in mammography and is poised to enter virtual
colonoscopy within a year or so. In this technique, software looks at the bowel images
collected and identifies areas that might be polyps. In combination with electronic
subtraction, CAD is poised to become a powerful backup tool. Although it is no replacement
for a reading by a human radiologist, CAD could serve as a double check. Its a
sort of a second read, says the University of Chicagos Dachman. And Westerman
predicts that CAD might make life a lot easier for the radiologist; [it] might save
an awful lot of time.
Currently, Dachman says that the University of Chicago, along with the National
Institutes of Health (Bethesda, Md) and Stanford University (Palo Alto, Calif), is working
on CAD programs that will be available soonthat is, likely within a year or 2. The
software will likely include a texture analysis component that analyzes masses to
determine which are fecal matter and which might be polyps.
Ultimately, virtual colonoscopy just might be the first step toward a virtual view of
nearly any hollow organ. Westerman predicts that CT endoscopy can be used for
anything tubular. It could open the doors to a variety of virtual, noninvasive
procedures that supplement, complement, or even replace a more traditional viewing method.
And most experts agree that any procedure that is easier and more attractive to patients
will improve acceptance of colon screening, taking a huge step toward widespread earlier
detection of colon cancer. s