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

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  • 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
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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 languageEnglish
JournalGastrointestinal Endoscopy
Volume89
Issue number3
Pages (from-to) 545-553
Number of pages8
ISSN0016-5107
DOIs
Publication statusPublished - 15 Mar 2019

ID: 56361252