RSS-Feed abonnieren
DOI: 10.1055/s-2007-966452
© Georg Thieme Verlag KG Stuttgart · New York
Proof-of-concept study of the Aer-O-Scope™ omnidirectional colonoscopic viewing system in ex vivo and in vivo porcine models
Publikationsverlauf
submitted 18 March 2007
accepted after revision 5 April 2007
Publikationsdatum:
22. Mai 2007 (online)
![](https://www.thieme-connect.de/media/endoscopy/200705/lookinside/thumbnails/10.1055-s-2007-966452-1.jpg)
Background and study aims: The limited angle of view of standard colonoscopes means that lesions can be missed. A multidirectional viewing system (OmniVision) has been developed recently and has been incorporated into the Aer-O-Scope™ (GI View Ltd., Ramat Gan, Israel), a disposable, self-propelling, and self-navigating colonoscope. The objectives of this study were to qualitatively assess the sensitivity of this viewing system in an ex vivo porcine polyp induction model, and to demonstrate its feasibility and safety in live pigs.
Materials and methods: For the ex vivo part of the study, six red metal beads of various sizes were randomly sewn into the mucosa of an unfolded, 2-meter-long porcine colonic segment. Seven passages of the Aer-O-Scope™ were video-recorded separately and blindly reviewed by six experienced gastroenterologists. The sensitivity of the Aer-O-Scope™ to detect beads of various sizes was calculated. For the in vivo experiment, in a repeated-measure study, nine female domestic pigs were examined with the Aer-O-Scope™ with the OmniView optics, followed immediately by examination with standard optical colonoscopy in order to assess the integrity of the colonic mucosa.
Results: In the ex vivo study the sensitivity of the Aer-O-Scope™ was 97.6 % (CI 94.0 % - 100 %) for any bead (i. e. any ”polyp”). The rate of polyp detection was similar for the six endoscopists, and was consistent for all bead sizes. The average false-positive rate was 0.3 % polyps per run (SD 0.61 %). The mean time taken for the video assessment was 8.0 minutes (SD 4.0 minutes). In the in vivo experiments with the Aer-O-Scope™, both the front-viewing and omnidirectional-viewing systems were functional in all cases. The colon in front of the optical capsule was well distended and a complete and meticulous inspection of the entire colonic mucosa was performed in all the pigs. There were no adverse events.
Conclusions: The OmniVision system allows for a highly sensitive inspection of the colonic mucosa without the need for tip manipulation. Clinical studies are warranted in order to validate these results in humans.
References
- 1 Winawer S J, Zauber A G, Ho M N. et al . Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993; 329 1977-1981
- 2 Rex D K, Rahmani E Y, Haseman J H. et al . Relative sensitivity of colonoscopy and barium enema for detection of colorectal cancer in clinical practice. Gastroenterology. 1997; 112 17-23
- 3 Hixson L J, Fennerty M B, Sampliner R E, Garewal H S. Prospective blinded trial of the colonoscopic miss-rate of large colorectal polyps. Gastrointest Endosc. 1991; 37 125-127
- 4 Rex D K, Cutler C S, Lemmel G T. et al . Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997; 112 24-28
- 5 Atkin W, Rogers P, Cardwell C. et al . Wide variation in adenoma detection rates at screening flexible sigmoidoscopy. Gastroenterology. 2004; 126 1247-1256
- 6 Sanchez W, Harewood G C, Petersen B T. Evaluation of polyp detection in relation to procedure time of screening or surveillance colonoscopy. Am J Gastroenterol. 2004; 99 1941-1945
- 7 Barclay R, Vicari J J, Johanson J F, Greenlaw R I. Variation in adenoma detection rates and colonoscopic withdrawal times during screening colonoscopy. Gastrointest Endosc. 2005; 61 AB107
- 8 Van Gelder R E, Nio C Y, Florie J. et al . Computed tomographic colonography compared with colonoscopy in patients at increased risk for colorectal cancer. Gastroenterology. 2004; 127 41-48
- 9 Pickhardt P J, Nugent P A, Mysliwiec P A. Location of adenomas missed by optical colonoscopy. Am Intern Med. 2004; 141 352-359
- 10 Miller R E, Lehman G. Polypoid colonic lesions undetected by endoscopy. Radiology. 1978; 129 295-297
- 11 Rex D, Chadalawada V, Helper D J. Wide angle colonoscopy with a prototype instrument: impact on miss rates and efficiency determined by back-to-back colonoscopies. Am J Gastroenterol. 2003; 98 2000-2005
- 12 Deenadayalu V P, Chadalawada V, Rex D K. 170 degrees wide-angle colonoscope: effect on efficiency and miss rates. Am J Gastroenterol. 2004; 99 2138-2142
- 13 Fatima H, Rex D K, Rahmani E. et al . Wide angle (WA) (170° angle of view) versus standard (ST) (140° angle of view) colonoscopy. Gastrointest Endosc. 2006; 63 AB204
- 14 Vucelic B, Rex D, Pulanic R. et al . The Aer-O-Scope™: proof of concept of a pneumatic, skill-independent, self-propelling, self-navigating colonoscope. Gastroenterology. 2006; 130 672-677
- 15 Pfeffer J, Grinshpon R, Rex D. et al . The Aer-O-Scope™: proof of the concept of a pneumatic, skill-independent, self-propelling, self-navigating colonoscope in a pig model. Endoscopy. 2006; 38 105-208
N. Arber, MD
Integrated Cancer Prevention Center
Tel-Aviv Sourasky Medical Center
6 Weizmann Street
Tel-Aviv 64239
Israel
Fax: +972-3-6950339
eMail: narber@post.tau.ac.il