G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos)

Haim Shirin; Beni Shpak; Julia Epshtein; John Gásdal Karstensen; Arthur Hoffman; Rogier de Ridder; Pier Alberto Testoni; Sauid Ishaq; D. Nageshwar Reddy; Seth A. Gross; Helmut Neumann; Martin Goetz; Dov Abramowich; Menachem Moshkowitz; Meir Mizrahi; Peter Vilmann; Johannes Wilhelm Rey; Silvia Sanduleanu-Dascalescu; Edi Viale; Hrushikesh Chaudhari; Mark B. Pochapin; Michael Yair; Mati Shnell; Shaul Yaari; Jakob Westergren Hendel; Daniel Teubner; Roel M.M. Bogie; Chiara Notaristefano; Roman Simantov; Nathan Gluck; Eran Israeli; Trine Stigaard; Shay Matalon; Alexander Vilkin; Ariel Benson; Stine Sloth; Amit Maliar; Amir Waizbard; Harold Jacob; Peter Thielsen; Eyal Shachar; Shmuel Rochberger; Tiberiu Hershcovici; Julie Isabelle Plougmann; Michal Braverman; Eduard Tsvang; Armita Armina Abedi; Yuri Brachman; Peter D. Siersema; Ralf Kiesslich

doi:10.1016/j.gie.2018.09.028

G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos)

Haim Shirin, Beni Shpak, Julia Epshtein, John Gásdal Karstensen, Arthur Hoffman, Rogier de Ridder, Pier Alberto Testoni, Sauid Ishaq, D. Nageshwar Reddy, Seth A. Gross, Helmut Neumann, Martin Goetz, Dov Abramowich, Menachem Moshkowitz, Meir Mizrahi, Peter Vilmann, Johannes Wilhelm Rey, Silvia Sanduleanu-Dascalescu, Edi Viale, Hrushikesh ChaudhariMark B. Pochapin, Michael Yair, Mati Shnell, Shaul Yaari, Jakob Westergren Hendel, Daniel Teubner, Roel M.M. Bogie, Chiara Notaristefano, Roman Simantov, Nathan Gluck, Eran Israeli, Trine Stigaard, Shay Matalon, Alexander Vilkin, Ariel Benson, Stine Sloth, Amit Maliar, Amir Waizbard, Harold Jacob, Peter Thielsen, Eyal Shachar, Shmuel Rochberger, Tiberiu Hershcovici, Julie Isabelle Plougmann, Michal Braverman, Eduard Tsvang, Armita Armina Abedi, Yuri Brachman, Peter D. Siersema, Ralf Kiesslich^*

^*Corresponding author for this work

Department of Clinical Medicine

12 Citations (Scopus)

29 Downloads (Pure)

Abstract

Background and Aims: Colorectal cancer (CRC) is largely preventable with routine screening and surveillance colonoscopy; however, interval cancers arising from precancerous lesions missed by standard colonoscopy still occur. An increased adenoma detection rate (ADR) has been found to be inversely associated with interval cancers. The G-EYE device includes a reusable balloon integrated at the distal tip of a standard colonoscope, which flattens haustral folds, centralizes the colonoscope's optics, and reduces bowel slippage. The insufflated balloon also aims to enhance visualization of the colon during withdrawal, thereby increasing the ADR. Methods: In this randomized, controlled, international, multicenter study (11 centers), patients (aged ≥50 years) referred to colonoscopy for screening, surveillance, or changes in bowel habits were randomized to undergo either balloon-assisted colonoscopy by using an insufflated balloon during withdrawal or standard high-definition colonoscopy. The primary endpoint was the ADR. Results: One thousand patients were enrolled between May 2014 and September 2016 to undergo colonoscopy by experienced endoscopists; 803 were finally analyzed (standard colonoscopy n = 396; balloon-assisted colonoscopy n = 407). Baseline parameters were similar in both groups. Balloon-assisted colonoscopy provided a 48.0% ADR compared with 37.5% in the standard colonoscopy group (28% increase; P =.0027). Additionally, balloon-assisted colonoscopy provided for a significant increase in detection of advanced (P =.0033) flat adenomas (P <.0001) and sessile serrated adenomas/polyps (P =.0026). Conclusion: Balloon-assisted colonoscopy yielded a higher ADR and increased the detection of advanced, flat, and sessile serrated adenomas/polyps when compared with standard colonoscopy. Improved detection by the G-EYE device could impact the quality of CRC screening by reducing miss rates and consequently reducing interval cancer incidence. (Clinical trial registration number: NCT01917513.)

Original language	English
Journal	Gastrointestinal Endoscopy
Volume	89
Issue number	3
Pages (from-to)	545-553
Number of pages	9
ISSN	0016-5107
DOIs	https://doi.org/10.1016/j.gie.2018.09.028
Publication status	Published - 2019

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G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos)Final published version, 1.12 MBLicence: CC BY-NC-ND

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Shirin, H., Shpak, B., Epshtein, J., Karstensen, J. G., Hoffman, A., de Ridder, R., Testoni, P. A., Ishaq, S., Reddy, D. N., Gross, S. A., Neumann, H., Goetz, M., Abramowich, D., Moshkowitz, M., Mizrahi, M., Vilmann, P., Rey, J. W., Sanduleanu-Dascalescu, S., Viale, E., ... Kiesslich, R. (2019). G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos). Gastrointestinal Endoscopy, 89(3), 545-553. https://doi.org/10.1016/j.gie.2018.09.028

Shirin, H, Shpak, B, Epshtein, J, Karstensen, JG, Hoffman, A, de Ridder, R, Testoni, PA, Ishaq, S, Reddy, DN, Gross, SA, Neumann, H, Goetz, M, Abramowich, D, Moshkowitz, M, Mizrahi, M, Vilmann, P, Rey, JW, Sanduleanu-Dascalescu, S, Viale, E, Chaudhari, H, Pochapin, MB, Yair, M, Shnell, M, Yaari, S, Hendel, JW, Teubner, D, Bogie, RMM, Notaristefano, C, Simantov, R, Gluck, N, Israeli, E, Stigaard, T, Matalon, S, Vilkin, A, Benson, A, Sloth, S, Maliar, A, Waizbard, A, Jacob, H, Thielsen, P, Shachar, E, Rochberger, S, Hershcovici, T, Plougmann, JI, Braverman, M, Tsvang, E, Abedi, AA, Brachman, Y, Siersema, PD & Kiesslich, R 2019, 'G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos)', Gastrointestinal Endoscopy, vol. 89, no. 3, pp. 545-553. https://doi.org/10.1016/j.gie.2018.09.028

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title = "G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos)",

abstract = "Background and Aims: Colorectal cancer (CRC) is largely preventable with routine screening and surveillance colonoscopy; however, interval cancers arising from precancerous lesions missed by standard colonoscopy still occur. An increased adenoma detection rate (ADR) has been found to be inversely associated with interval cancers. The G-EYE device includes a reusable balloon integrated at the distal tip of a standard colonoscope, which flattens haustral folds, centralizes the colonoscope's optics, and reduces bowel slippage. The insufflated balloon also aims to enhance visualization of the colon during withdrawal, thereby increasing the ADR. Methods: In this randomized, controlled, international, multicenter study (11 centers), patients (aged ≥50 years) referred to colonoscopy for screening, surveillance, or changes in bowel habits were randomized to undergo either balloon-assisted colonoscopy by using an insufflated balloon during withdrawal or standard high-definition colonoscopy. The primary endpoint was the ADR. Results: One thousand patients were enrolled between May 2014 and September 2016 to undergo colonoscopy by experienced endoscopists; 803 were finally analyzed (standard colonoscopy n = 396; balloon-assisted colonoscopy n = 407). Baseline parameters were similar in both groups. Balloon-assisted colonoscopy provided a 48.0% ADR compared with 37.5% in the standard colonoscopy group (28% increase; P =.0027). Additionally, balloon-assisted colonoscopy provided for a significant increase in detection of advanced (P =.0033) flat adenomas (P <.0001) and sessile serrated adenomas/polyps (P =.0026). Conclusion: Balloon-assisted colonoscopy yielded a higher ADR and increased the detection of advanced, flat, and sessile serrated adenomas/polyps when compared with standard colonoscopy. Improved detection by the G-EYE device could impact the quality of CRC screening by reducing miss rates and consequently reducing interval cancer incidence. (Clinical trial registration number: NCT01917513.)",

author = "Haim Shirin and Beni Shpak and Julia Epshtein and Karstensen, {John G{\'a}sdal} and Arthur Hoffman and {de Ridder}, Rogier and Testoni, {Pier Alberto} and Sauid Ishaq and Reddy, {D. Nageshwar} and Gross, {Seth A.} and Helmut Neumann and Martin Goetz and Dov Abramowich and Menachem Moshkowitz and Meir Mizrahi and Peter Vilmann and Rey, {Johannes Wilhelm} and Silvia Sanduleanu-Dascalescu and Edi Viale and Hrushikesh Chaudhari and Pochapin, {Mark B.} and Michael Yair and Mati Shnell and Shaul Yaari and Hendel, {Jakob Westergren} and Daniel Teubner and Bogie, {Roel M.M.} and Chiara Notaristefano and Roman Simantov and Nathan Gluck and Eran Israeli and Trine Stigaard and Shay Matalon and Alexander Vilkin and Ariel Benson and Stine Sloth and Amit Maliar and Amir Waizbard and Harold Jacob and Peter Thielsen and Eyal Shachar and Shmuel Rochberger and Tiberiu Hershcovici and Plougmann, {Julie Isabelle} and Michal Braverman and Eduard Tsvang and Abedi, {Armita Armina} and Yuri Brachman and Siersema, {Peter D.} and Ralf Kiesslich",

year = "2019",

doi = "10.1016/j.gie.2018.09.028",

language = "English",

volume = "89",

pages = "545--553",

journal = "Gastrointestinal Endoscopy",

issn = "0016-5107",

publisher = "Mosby Inc.",

number = "3",

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TY - JOUR

T1 - G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate

T2 - an international randomized controlled trial (with videos)

AU - Shirin, Haim

AU - Shpak, Beni

AU - Epshtein, Julia

AU - Karstensen, John Gásdal

AU - Hoffman, Arthur

AU - de Ridder, Rogier

AU - Testoni, Pier Alberto

AU - Ishaq, Sauid

AU - Reddy, D. Nageshwar

AU - Gross, Seth A.

AU - Neumann, Helmut

AU - Goetz, Martin

AU - Abramowich, Dov

AU - Moshkowitz, Menachem

AU - Mizrahi, Meir

AU - Vilmann, Peter

AU - Rey, Johannes Wilhelm

AU - Sanduleanu-Dascalescu, Silvia

AU - Viale, Edi

AU - Chaudhari, Hrushikesh

AU - Pochapin, Mark B.

AU - Yair, Michael

AU - Shnell, Mati

AU - Yaari, Shaul

AU - Hendel, Jakob Westergren

AU - Teubner, Daniel

AU - Bogie, Roel M.M.

AU - Notaristefano, Chiara

AU - Simantov, Roman

AU - Gluck, Nathan

AU - Israeli, Eran

AU - Stigaard, Trine

AU - Matalon, Shay

AU - Vilkin, Alexander

AU - Benson, Ariel

AU - Sloth, Stine

AU - Maliar, Amit

AU - Waizbard, Amir

AU - Jacob, Harold

AU - Thielsen, Peter

AU - Shachar, Eyal

AU - Rochberger, Shmuel

AU - Hershcovici, Tiberiu

AU - Plougmann, Julie Isabelle

AU - Braverman, Michal

AU - Tsvang, Eduard

AU - Abedi, Armita Armina

AU - Brachman, Yuri

AU - Siersema, Peter D.

AU - Kiesslich, Ralf

PY - 2019

Y1 - 2019

N2 - Background and Aims: Colorectal cancer (CRC) is largely preventable with routine screening and surveillance colonoscopy; however, interval cancers arising from precancerous lesions missed by standard colonoscopy still occur. An increased adenoma detection rate (ADR) has been found to be inversely associated with interval cancers. The G-EYE device includes a reusable balloon integrated at the distal tip of a standard colonoscope, which flattens haustral folds, centralizes the colonoscope's optics, and reduces bowel slippage. The insufflated balloon also aims to enhance visualization of the colon during withdrawal, thereby increasing the ADR. Methods: In this randomized, controlled, international, multicenter study (11 centers), patients (aged ≥50 years) referred to colonoscopy for screening, surveillance, or changes in bowel habits were randomized to undergo either balloon-assisted colonoscopy by using an insufflated balloon during withdrawal or standard high-definition colonoscopy. The primary endpoint was the ADR. Results: One thousand patients were enrolled between May 2014 and September 2016 to undergo colonoscopy by experienced endoscopists; 803 were finally analyzed (standard colonoscopy n = 396; balloon-assisted colonoscopy n = 407). Baseline parameters were similar in both groups. Balloon-assisted colonoscopy provided a 48.0% ADR compared with 37.5% in the standard colonoscopy group (28% increase; P =.0027). Additionally, balloon-assisted colonoscopy provided for a significant increase in detection of advanced (P =.0033) flat adenomas (P <.0001) and sessile serrated adenomas/polyps (P =.0026). Conclusion: Balloon-assisted colonoscopy yielded a higher ADR and increased the detection of advanced, flat, and sessile serrated adenomas/polyps when compared with standard colonoscopy. Improved detection by the G-EYE device could impact the quality of CRC screening by reducing miss rates and consequently reducing interval cancer incidence. (Clinical trial registration number: NCT01917513.)

AB - Background and Aims: Colorectal cancer (CRC) is largely preventable with routine screening and surveillance colonoscopy; however, interval cancers arising from precancerous lesions missed by standard colonoscopy still occur. An increased adenoma detection rate (ADR) has been found to be inversely associated with interval cancers. The G-EYE device includes a reusable balloon integrated at the distal tip of a standard colonoscope, which flattens haustral folds, centralizes the colonoscope's optics, and reduces bowel slippage. The insufflated balloon also aims to enhance visualization of the colon during withdrawal, thereby increasing the ADR. Methods: In this randomized, controlled, international, multicenter study (11 centers), patients (aged ≥50 years) referred to colonoscopy for screening, surveillance, or changes in bowel habits were randomized to undergo either balloon-assisted colonoscopy by using an insufflated balloon during withdrawal or standard high-definition colonoscopy. The primary endpoint was the ADR. Results: One thousand patients were enrolled between May 2014 and September 2016 to undergo colonoscopy by experienced endoscopists; 803 were finally analyzed (standard colonoscopy n = 396; balloon-assisted colonoscopy n = 407). Baseline parameters were similar in both groups. Balloon-assisted colonoscopy provided a 48.0% ADR compared with 37.5% in the standard colonoscopy group (28% increase; P =.0027). Additionally, balloon-assisted colonoscopy provided for a significant increase in detection of advanced (P =.0033) flat adenomas (P <.0001) and sessile serrated adenomas/polyps (P =.0026). Conclusion: Balloon-assisted colonoscopy yielded a higher ADR and increased the detection of advanced, flat, and sessile serrated adenomas/polyps when compared with standard colonoscopy. Improved detection by the G-EYE device could impact the quality of CRC screening by reducing miss rates and consequently reducing interval cancer incidence. (Clinical trial registration number: NCT01917513.)

U2 - 10.1016/j.gie.2018.09.028

DO - 10.1016/j.gie.2018.09.028

M3 - Journal article

C2 - 30273591

AN - SCOPUS:85056308396

SN - 0016-5107

VL - 89

SP - 545

EP - 553

JO - Gastrointestinal Endoscopy

JF - Gastrointestinal Endoscopy

IS - 3

ER -

G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos)

Abstract

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