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
N1 - Publisher Copyright:
© 2019 American Society for Gastrointestinal Endoscopy
PY - 2019/3
Y1 - 2019/3
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.)
UR - http://www.scopus.com/inward/record.url?scp=85056308396&partnerID=8YFLogxK
U2 - 10.1016/j.gie.2018.09.028
DO - 10.1016/j.gie.2018.09.028
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C2 - 30273591
AN - SCOPUS:85056308396
SN - 0016-5107
VL - 89
SP - 545
EP - 553
JO - Gastrointestinal Endoscopy
JF - Gastrointestinal Endoscopy
IS - 3
ER -
