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 Gasdal 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 Vihnann, 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 Siniantov, Nathan Gluck, Eran Israeli, Trine Stigaard, Shay Matalon, Alexander Vilkin, Ariel Benson, Stine Sloth, Amit Mahar, Ainir 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

Research output: Contribution to journalArticleAcademicpeer-review

14 Citations (Web of Science)

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-efinition 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 nZ396; 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

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 GEYE device could impact the quality of CRC screening by reducing miss rates and consequently reducing interval cancer incidence.

Original languageEnglish
Pages (from-to)545-553
Number of pages9
JournalGastrointestinal Endoscopy
Volume89
Issue number3
DOIs
Publication statusPublished - Mar 2019

Keywords

  • SOCIETY TASK-FORCE
  • ENDOCUFF-ASSISTED COLONOSCOPY
  • COLORECTAL-CANCER INCIDENCE
  • BALLOON COLONOSCOPE
  • TANDEM COLONOSCOPY
  • MISS RATE
  • INTERVAL
  • SURVEILLANCE
  • MULTICENTER
  • LESIONS

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