Published clinical reports documenting polyp miss rates associated with colonoscopy from
4% to as high as 36%
Why Third Eye
Colorectal Cancer
Colorectal cancer is the second leading cause of cancer death in the United States. Average-risk adults, 50 years of age and older, are advised to routinely undergo colorectal cancer screening in order to reduce the incidence and mortality associated with colorectal cancer1. In fact, estimates suggest that widespread adoption of colorectal cancer screening could possibly lead to greater than 50% reduction in colorectal cancer related mortality rates2.Screening for Colorectal Cancer
Clinical guidelines endorsed by the US Multisociety Task Force on Colorectal Cancer offer 5 different screening options for average-risk adults: (a) annual fecal occult blood test, (b) sigmoidoscopy every 5 years, (c) annual fecal occult blood test combined with sigmoidoscopy every 5 years, (d) barium enema every 5 years, and (e) colonoscopy every 10 years3. Among these colonoscopy is still considered the “gold standard” for colorectal cancer screening4-5.Lesion Miss Rates
Even colonoscopy, considered the most sensitive and specific method for detection of colorectal neoplasia, is not infallible. Published clinical reports documenting polyp miss rates associated with colonoscopy from 4% to as high as 36% (see Table 1) highlight the limitations of traditional colonoscopy.
- In a pivotal study at Indiana University, two endoscopists performed back-to-back colonoscopies on the same patients and reported an average miss rate of 24% of all adenomas (Rex 1997)6.
- A review of cancer patients enrolled in a dietary Polyp Prevention Trial showed that 23% of patients with cancer had a “normal” colonoscopy within 30 months of their diagnosis, representing the miss rate of cancer or precancerous adenomas (Pabby 2005)7.
- Finally in a meta-analysis of 6 tandem colonoscopy studies, the overall average miss rate was 22% (van Rijn 2006)8.
Why are so many lesions missed with colonoscopy? Most clinically significant adenomas missed during colonoscopy are located behind the folds of the colon or near the anal verge. Pickhardt, et al. reported that 71.4% of neoplasms missed during colonoscopic evaluation were situated on the proximal aspect of folds9. Small polyps in “blind spots”, behind these folds, can easily be missed, even under the most meticulous examination.
Why Third Eye?
The Third Eye Retroscope offers a straightforward, practical solution. The Third Eye Retroscope is an imaging device that illuminates and delivers a continuous retrograde view of the colon. When used in conjunction with a colonoscope, it allows the physician to look behind the folds to find hidden lesions and potentially increases diagnostic yield without significantly impacting procedural time10. The Third Eye addresses the significant unmet need to reduce the miss rates of standard colonoscopy.
References
1. Pignone M, Rich M, Teutsch SM, Berg AO, Lohr KN. Screening for colorectal cancer in adults at average risk: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2002; 137(2):132-41.
2. Bond JH. Screening guidelines for colorectal cancer. Am J Med. 1999; 106(1A):7S-10S.
3. Winawer S, Fletcher R, Rex D, Bond J, Burt R, Ferrucci J, Ganiats T, Levin T, Woolf S, Johnson D, Kirk L, Litin S, Simmang C; Gastrointestinal Consortium Panel. Colorectal cancer screening and surveillance: clinical guidelines and rationale-Update based on new evidence. Gastroenterology. 2003; 124(2):544- 60.
4. Winawer SJ, Stewart ET, Zauber AG, Bond JH, Ansel H, Waye JD, et al. A comparison of colonoscopy and double-contrast barium enema for surveillance after polypectomy. National Polyp Study Work Group. N Engl J Med. 2000; 342:1766-72.
5. Bond JH. Colon polyps and cancer. Endoscopy. 2003; 35:27-35.
6. Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic Miss Rates of Adenomas Determined by Back-to- Back Colonoscopies. Gastroenterology. 1997 Jan; 112(1):24-8.
7. Pabby A, Schoen RE, Weissfeld JI, Burt R, Kikendall JW, Lance P, Shike M, Lanza E, Schatzkin A. Analysis of colorectal cancer occurrence during surveillance colonoscopy in the dietary Polyp Prevention Trial. Gastrointest Endosc 2005,61:385-391.
8. van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp Miss Rate Determined by Tandem Colonoscopy: A Systematic Review. Am J Gastroenterol. 2006 Feb; 101(2):343-50.
9. Pickhardt PJ, Nugent PA, Mysliwiec PA, Choi JR, Schindler WR. Location of Adenomas Missed by Optical Colonoscopy Ann Intern Med. 2004 Sep 7; 141(5):352-9.
10. Triadafilopoulos G, Li J. A pilot study to assess the safety and efficacy of the Third Eye retrograde auxiliary imaging system during colonoscopy. Endoscopy. 2008 Jun;40(6):478-82
11. Kaltenbach T, Friedland S, Soetikno R.A. Randomized tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates. Gut. 2008 Jun 3.
12. Heresbach D, Barrioz T, Lapalus MG, Coumaros D, Bauret P, Potier P, Sautereau D, Boustière C, Grimaud JC, Barthélémy C, Sée J, Serraj I, D'Halluin PN, Branger B, Ponchon T. Miss Rate for Colorectal Neoplastic Polyps: A Prospective Multicenter Study of Back-to-Back Video Colonoscopies. Endoscopy. 2008 Apr; 40(4):284-90.
13. Stergiou N, Frenz MB, Menke D, Riphaus A, Wehrmann T. Int J Colorectal Dis. Reduction of Miss Rates of Colonic Adenomas by Zoom Chromoendoscopy. 2006 Sep;21(6):560-5. Epub 2005 Nov 8.
14. Deenadayalu VP, Chadalawada V, Rex DK. 170 Degrees Wide-Angle Colonoscope: Effect on Efficiency and Miss Rates. Am J Gastroenterol. 2004 Nov; 99(11):2138-42.
15. Bressler B, Paszat LF, Vinden C, Li C, He J, Rabeneck L. Colonoscopic Miss Rates for Right-Sided Colon Cancer: A Population Based Analysis. Gastroenterology. 2004 Aug; 127(2):452-6.
16. Harrison M, Singh N, Rex DK. Am J Gastroenterol. Impact of Proximal Colon
Retroflexion on Adenoma Miss Rates. 2004 Mar; 99(3):519-22.
17. Rex DK, Chadalawada V, Helper DJ. Am J Gastroenterol. Wide Angle Colonoscopy with a Prototype Instrument: Impact on Miss Rates and Efficiency as Determined by Back-to-Back Colonoscopies. 2003 Sep; 98(9):2000-5.
18. Shehadeh I, Rebala S, Kumar R, Markert RJ, Barde C, Gopalswamy. Retrospective Analysis of Missed Advanced Adenomas on Surveillance Colonoscopy. N. Am J Gastroenterol.2002 May; 97(5):1143-7.
19. Bensen S, Mott LA, Dain B, Rothstein R, Baron J. Colonoscopic Miss Rates Determined by Direct Comparison of Colonoscopy with Colon Resection Specimens. Am J Gastroenterol. 1999 Jan; 94(1):194-9.
20. Hixson LJ, Fennerty MB, Sampliner RE, Garewal HS. Prospective Blinded Trial of the Colonoscopic Miss-Rate of Large Colorectal Polyps. Gastrointest Endosc. 1991 Mar-Apr; 37(2):125-7.
21. Hixson LJ, Fennerty MB, Sampliner RE, McGee D, Garewal H. Prospective Study of the Frequency and Size Distribution of Polyps Missed by Colonoscope. J Natl Cancer Inst. 1990 Nov 21; 82(22):1769-72.
22. Postic G, Lewin D, Bickerstaff C, Wallace MB. Colonoscopic Miss Rates Determined by Direct Comparison of Colonoscopy with Colon Resection Specimens. Am J Gastroenterol. 2002 Dec; 97(12):3182-5.
23. Stergiou N, Frenz MB, Menke D, Riphaus A, Wehrmann T. Reduction of Miss Rates of Colonic Adenomas by Zoom Chromoendoscopy. Int J Colorectal Dis. 2006 Sep;21(6):560-5. Epub 2005 Nov 8.
MKT 16040, Rev A