Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: The TERRACE study

Anke M. Leufkens; Daniel C. Demarco; Amit Rastogi; Paul A. Akerman; Kassem Azzouzi; Richard I. Rothstein; Frank P. Vleggaar; Alessandro Repici; Giacomo Rando; Patrick I. Okolo; Olivier Dewit; Ana Ignjatovic; Elizabeth Odstrcil; James East; Pierre H. Deprez; Brian P. Saunders; Anthony N. Kalloo; Bradley Creel; Vikas Singh; Anne Marie Lennon; Peter D. Siersema

doi:10.1016/j.gie.2010.09.004

Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: The TERRACE study

Anke M. Leufkens, Daniel C. Demarco, Amit Rastogi, Paul A. Akerman, Kassem Azzouzi, Richard I. Rothstein, Frank P. Vleggaar, Alessandro Repici, Giacomo Rando, Patrick I. Okolo, Olivier Dewit, Ana Ignjatovic, Elizabeth Odstrcil, James East, Pierre H. Deprez, Brian P. Saunders, Anthony N. Kalloo, Bradley Creel, Vikas Singh, Anne Marie LennonPeter D. Siersema

School of Medicine

Research output: Contribution to journal › Article › peer-review

139 Scopus citations

Abstract

Background: Although colonoscopy is currently the optimal method for detecting colorectal polyps, some are missed. The Third Eye Retroscope provides an additional retrograde view that may detect polyps behind folds. Objective: To determine whether the addition of the Third Eye Retroscope to colonoscopy improves the adenoma detection rate. Design: Prospective, multicenter, randomized, controlled trial. Setting: Nine European and U.S. centers. Patients: Of 448 enrolled subjects, 395 had data for 2 procedures. Interventions: Subjects underwent same-day tandem examinations with standard colonoscopy (SC) and Third Eye colonoscopy (TEC). Subjects were randomized to SC followed by TEC or TEC followed by SC. Main Outcome Measurements: Detection rates for all polyps and adenomas with each method. Results: In the per-protocol population, 173 subjects underwent SC and then TEC, and TEC yielded 78 additional polyps (48.8%), including 49 adenomas (45.8%). In 176 subjects undergoing TEC and then SC, SC yielded 31 additional polyps (19.0%), including 26 adenomas (22.6%). Net additional detection rates with TEC were 29.8% for polyps and 23.2% for adenomas. The relative risk of missing with SC compared with TEC was 2.56 for polyps (P < .001) and 1.92 for adenomas (P = .029). Mean withdrawal times for SC and TEC were 7.58 and 9.52 minutes, respectively (P < .001). The median difference in withdrawal times was 1 minute (P < .001). The mean total procedure times for SC and TEC were 16.97 and 20.87 minutes, respectively (P < .001). Limitations: Despite randomization and a large cohort, there was disparity in polyp prevalence between the 2 groups of subjects. Conclusion: The Third Eye Retroscope increases adenoma detection rate by visualizing areas behind folds. (Clinical trial registration number: NCT01044732.)

Original language	English (US)
Pages (from-to)	480-489
Number of pages	10
Journal	Gastrointestinal endoscopy
Volume	73
Issue number	3
DOIs	https://doi.org/10.1016/j.gie.2010.09.004
State	Published - Mar 2011

Keywords

ADR
ITT
PDR
SC
TEC
TER
Third Eye Retroscope
Third Eye colonoscopy
adenoma detection rate
intent to treat
polyp detection rate
standard colonoscopy

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging
Gastroenterology

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10.1016/j.gie.2010.09.004

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Leufkens, A. M., Demarco, D. C., Rastogi, A., Akerman, P. A., Azzouzi, K., Rothstein, R. I., Vleggaar, F. P., Repici, A., Rando, G., Okolo, P. I., Dewit, O., Ignjatovic, A., Odstrcil, E., East, J., Deprez, P. H., Saunders, B. P., Kalloo, A. N., Creel, B., Singh, V., ... Siersema, P. D. (2011). Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: The TERRACE study. Gastrointestinal endoscopy, 73(3), 480-489. https://doi.org/10.1016/j.gie.2010.09.004

Leufkens, AM, Demarco, DC, Rastogi, A, Akerman, PA, Azzouzi, K, Rothstein, RI, Vleggaar, FP, Repici, A, Rando, G, Okolo, PI, Dewit, O, Ignjatovic, A, Odstrcil, E, East, J, Deprez, PH, Saunders, BP, Kalloo, AN, Creel, B, Singh, V, Lennon, AM & Siersema, PD 2011, 'Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: The TERRACE study', Gastrointestinal endoscopy, vol. 73, no. 3, pp. 480-489. https://doi.org/10.1016/j.gie.2010.09.004

@article{1a2a667937b646cd8a403e98a0001b51,

title = "Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: The TERRACE study",

abstract = "Background: Although colonoscopy is currently the optimal method for detecting colorectal polyps, some are missed. The Third Eye Retroscope provides an additional retrograde view that may detect polyps behind folds. Objective: To determine whether the addition of the Third Eye Retroscope to colonoscopy improves the adenoma detection rate. Design: Prospective, multicenter, randomized, controlled trial. Setting: Nine European and U.S. centers. Patients: Of 448 enrolled subjects, 395 had data for 2 procedures. Interventions: Subjects underwent same-day tandem examinations with standard colonoscopy (SC) and Third Eye colonoscopy (TEC). Subjects were randomized to SC followed by TEC or TEC followed by SC. Main Outcome Measurements: Detection rates for all polyps and adenomas with each method. Results: In the per-protocol population, 173 subjects underwent SC and then TEC, and TEC yielded 78 additional polyps (48.8%), including 49 adenomas (45.8%). In 176 subjects undergoing TEC and then SC, SC yielded 31 additional polyps (19.0%), including 26 adenomas (22.6%). Net additional detection rates with TEC were 29.8% for polyps and 23.2% for adenomas. The relative risk of missing with SC compared with TEC was 2.56 for polyps (P < .001) and 1.92 for adenomas (P = .029). Mean withdrawal times for SC and TEC were 7.58 and 9.52 minutes, respectively (P < .001). The median difference in withdrawal times was 1 minute (P < .001). The mean total procedure times for SC and TEC were 16.97 and 20.87 minutes, respectively (P < .001). Limitations: Despite randomization and a large cohort, there was disparity in polyp prevalence between the 2 groups of subjects. Conclusion: The Third Eye Retroscope increases adenoma detection rate by visualizing areas behind folds. (Clinical trial registration number: NCT01044732.)",

keywords = "ADR, ITT, PDR, SC, TEC, TER, Third Eye Retroscope, Third Eye colonoscopy, adenoma detection rate, intent to treat, polyp detection rate, standard colonoscopy",

author = "Leufkens, {Anke M.} and Demarco, {Daniel C.} and Amit Rastogi and Akerman, {Paul A.} and Kassem Azzouzi and Rothstein, {Richard I.} and Vleggaar, {Frank P.} and Alessandro Repici and Giacomo Rando and Okolo, {Patrick I.} and Olivier Dewit and Ana Ignjatovic and Elizabeth Odstrcil and James East and Deprez, {Pierre H.} and Saunders, {Brian P.} and Kalloo, {Anthony N.} and Bradley Creel and Vikas Singh and Lennon, {Anne Marie} and Siersema, {Peter D.}",

note = "Funding Information: Fifteen endoscopists at 4 European and 5 U.S. sites performed at least 10 to 15 practice cases by using the TER before starting the trial. Patients undergoing colonoscopy for screening, surveillance after previous polypectomy, or as a diagnostic workup were recruited. Exclusion criteria included a history of colonic resection, inflammatory bowel disease, polyposis syndrome, radiation therapy to the abdomen or pelvis, suspicion of colonic stricture, active diverticulitis, or concurrent enrollment in another study. The protocol was approved by each institution's institutional review board, and all patients signed informed consent. Bowel preparation complied with standard protocol for each institution and was graded with the Ottawa Bowel Preparation Quality Scale Score. 12 Subjects were enrolled between March 2009 and February 2010. Research support for this study was provided by Avantis Medical Systems, Sunnyvale, California. ",

year = "2011",

month = mar,

doi = "10.1016/j.gie.2010.09.004",

language = "English (US)",

volume = "73",

pages = "480--489",

journal = "Gastrointestinal endoscopy",

issn = "0016-5107",

publisher = "Mosby Inc.",

number = "3",

}

TY - JOUR

T1 - Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy

T2 - The TERRACE study

AU - Leufkens, Anke M.

AU - Demarco, Daniel C.

AU - Rastogi, Amit

AU - Akerman, Paul A.

AU - Azzouzi, Kassem

AU - Rothstein, Richard I.

AU - Vleggaar, Frank P.

AU - Repici, Alessandro

AU - Rando, Giacomo

AU - Okolo, Patrick I.

AU - Dewit, Olivier

AU - Ignjatovic, Ana

AU - Odstrcil, Elizabeth

AU - East, James

AU - Deprez, Pierre H.

AU - Saunders, Brian P.

AU - Kalloo, Anthony N.

AU - Creel, Bradley

AU - Singh, Vikas

AU - Lennon, Anne Marie

AU - Siersema, Peter D.

N1 - Funding Information: Fifteen endoscopists at 4 European and 5 U.S. sites performed at least 10 to 15 practice cases by using the TER before starting the trial. Patients undergoing colonoscopy for screening, surveillance after previous polypectomy, or as a diagnostic workup were recruited. Exclusion criteria included a history of colonic resection, inflammatory bowel disease, polyposis syndrome, radiation therapy to the abdomen or pelvis, suspicion of colonic stricture, active diverticulitis, or concurrent enrollment in another study. The protocol was approved by each institution's institutional review board, and all patients signed informed consent. Bowel preparation complied with standard protocol for each institution and was graded with the Ottawa Bowel Preparation Quality Scale Score. 12 Subjects were enrolled between March 2009 and February 2010. Research support for this study was provided by Avantis Medical Systems, Sunnyvale, California.

PY - 2011/3

Y1 - 2011/3

N2 - Background: Although colonoscopy is currently the optimal method for detecting colorectal polyps, some are missed. The Third Eye Retroscope provides an additional retrograde view that may detect polyps behind folds. Objective: To determine whether the addition of the Third Eye Retroscope to colonoscopy improves the adenoma detection rate. Design: Prospective, multicenter, randomized, controlled trial. Setting: Nine European and U.S. centers. Patients: Of 448 enrolled subjects, 395 had data for 2 procedures. Interventions: Subjects underwent same-day tandem examinations with standard colonoscopy (SC) and Third Eye colonoscopy (TEC). Subjects were randomized to SC followed by TEC or TEC followed by SC. Main Outcome Measurements: Detection rates for all polyps and adenomas with each method. Results: In the per-protocol population, 173 subjects underwent SC and then TEC, and TEC yielded 78 additional polyps (48.8%), including 49 adenomas (45.8%). In 176 subjects undergoing TEC and then SC, SC yielded 31 additional polyps (19.0%), including 26 adenomas (22.6%). Net additional detection rates with TEC were 29.8% for polyps and 23.2% for adenomas. The relative risk of missing with SC compared with TEC was 2.56 for polyps (P < .001) and 1.92 for adenomas (P = .029). Mean withdrawal times for SC and TEC were 7.58 and 9.52 minutes, respectively (P < .001). The median difference in withdrawal times was 1 minute (P < .001). The mean total procedure times for SC and TEC were 16.97 and 20.87 minutes, respectively (P < .001). Limitations: Despite randomization and a large cohort, there was disparity in polyp prevalence between the 2 groups of subjects. Conclusion: The Third Eye Retroscope increases adenoma detection rate by visualizing areas behind folds. (Clinical trial registration number: NCT01044732.)

AB - Background: Although colonoscopy is currently the optimal method for detecting colorectal polyps, some are missed. The Third Eye Retroscope provides an additional retrograde view that may detect polyps behind folds. Objective: To determine whether the addition of the Third Eye Retroscope to colonoscopy improves the adenoma detection rate. Design: Prospective, multicenter, randomized, controlled trial. Setting: Nine European and U.S. centers. Patients: Of 448 enrolled subjects, 395 had data for 2 procedures. Interventions: Subjects underwent same-day tandem examinations with standard colonoscopy (SC) and Third Eye colonoscopy (TEC). Subjects were randomized to SC followed by TEC or TEC followed by SC. Main Outcome Measurements: Detection rates for all polyps and adenomas with each method. Results: In the per-protocol population, 173 subjects underwent SC and then TEC, and TEC yielded 78 additional polyps (48.8%), including 49 adenomas (45.8%). In 176 subjects undergoing TEC and then SC, SC yielded 31 additional polyps (19.0%), including 26 adenomas (22.6%). Net additional detection rates with TEC were 29.8% for polyps and 23.2% for adenomas. The relative risk of missing with SC compared with TEC was 2.56 for polyps (P < .001) and 1.92 for adenomas (P = .029). Mean withdrawal times for SC and TEC were 7.58 and 9.52 minutes, respectively (P < .001). The median difference in withdrawal times was 1 minute (P < .001). The mean total procedure times for SC and TEC were 16.97 and 20.87 minutes, respectively (P < .001). Limitations: Despite randomization and a large cohort, there was disparity in polyp prevalence between the 2 groups of subjects. Conclusion: The Third Eye Retroscope increases adenoma detection rate by visualizing areas behind folds. (Clinical trial registration number: NCT01044732.)

KW - ADR

KW - ITT

KW - PDR

KW - SC

KW - TEC

KW - TER

KW - Third Eye Retroscope

KW - Third Eye colonoscopy

KW - adenoma detection rate

KW - intent to treat

KW - polyp detection rate

KW - standard colonoscopy

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DO - 10.1016/j.gie.2010.09.004

M3 - Article

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SN - 0016-5107

VL - 73

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JO - Gastrointestinal endoscopy

JF - Gastrointestinal endoscopy

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ER -

Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: The TERRACE study

Abstract

Keywords

ASJC Scopus subject areas

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