At the beginning of February, Given Imaging announced that it received FDA clearance for PillCam COLON. William Katkov, MD, a gastroenterologist with Saint John's Health Center in Santa Monica, Calif., responds to the approval and takes a look at the role the PillCam will play in the field of gastroenterology. Question: What role do you think PillCam COLON plays alongside traditional colonoscopy?
Dr. William Katkov: The approval of PillCam Colon by the FDA is an exciting development. It will help gastroenterologists in achieving one of our most important goals: getting as many people as possible screened for colorectal cancer in a safe, cost effective manner.
Colonoscopy and PillCam both rely on a thorough, high-quality preparation for accuracy. While it is unclear what role PillCam will play in first line colorectal cancer screening, this new technology will be particularly useful for the occasional case of a difficult colonoscopy that prevents a complete examination of the colon. Technically challenging colonoscopies do not always reflect underlying serious pathology. A classic example is when a patient who has undergone pelvic or abdominal surgery in the past has scar tissue or adhesions. This can result in a loss of flexibility and pliability in the colon. Prior to PillCam, physicians would choose between attempting the procedure a second time, virtual colonoscopy or completely foregoing the screening process.
Q: How reliable of a tool is PillCam? Are there any limitations?
WK: In recent studies, the sensitivity and specificity of PillCam for detecting polyps and cancer is high, but it isn't perfect. Colonoscopy remains the gold standard for colon cancer prevention: the detection and removal of polyps that interrupts the polyp-to-cancer process.
One important aspect of PillCam is that, unlike virtual colonoscopy, it does not involve radiation. Many people are becoming increasingly concerned with the risks of ionizing radiation associated with radiologic studies.
PillCam is a low risk procedure. The most important contraindication to capsule endoscopy is any increased risk of the capsule not passing freely through the small intestine and becoming lodged. A patient with Crohn's disease and small intestinal strictures would not be a candidate for PillCam.
Q: How does the interpretation of results vary between PillCam and colonoscopy?
WK: Resolution with capsule endoscopy is very impressive, but there is a learning curve involved in interpreting the examinations. Colonoscopy occurs in real-time, while the results of PillCam will be reviewed after it has passed through a patient's digestive tract. It is likely that one or two members of a GI practice will become skilled in reading the PillCam results.
Q: Do you think that PillCam will be adopted as a regular option in most gastroenterology practices?
WK: PillCam has the potential to become an important part of the arsenal in a gastroenterologist's office. The efficiency and integration of the technology is very appealing. We have had capsule endoscopy for the evaluation of the small intestine in our practice for many years. We are working with Given Imaging to expand our service line to include PillCam.
PillCam would ideally be available in the endoscopy center so patients with incomplete colonoscopies could move to capsule colonoscopy while fully prepared immediately after an incomplete colonoscopy. At this time, I believe it will generally be an office-based modality.
Q: Is PillCam a cost-effective option for patients?
WK: The aggregate cost is less expensive than colonoscopy and it does interfere less with patient's lives. However it is important to consider whether or not the sensitivity is sufficient to use PillCam as a primary screening tool. Issues of sensitivity, specificity and patient acceptability are going to factor into this. There is a definite measurable rate of false positives associated with PillCam. Is it going to be acceptable for patients to undergo the preparation process for PillCam and then a second preparation for a normal colonoscopy? Many questions will be asked and answered about this exciting new technology in the near future.
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